Pharmaceutical & Medical Devices Comparative Guide

1. Legal and enforcement framework

1.1 Which legislative and regulatory provisions govern (a) pharmaceuticals and (b) medical devices in your jurisdiction?

(a) Pharmaceuticals

The main laws and decrees governing pharmaceuticals in Egypt are as follows:

• the Pharmacy Law (127/1955), as amended, most recently by Law 167/1998;
• Ministerial Resolution 265/1981 on the health and technical requirements that must be met in pharmaceutical factories;
• Minister of Health Decree 499/2012 on the mandatory profit margins for distributors and pharmacists;
• Law 151/2019 on the establishment and regulation of two new public authorities in the pharmaceutical sector:
• • the Egyptian Drug Authority (EDA); and
  • the Authority for Unified Procurement, Medical Supply and Technology Management (UPA);
• Prime Ministerial Decree 777/2020 on the issuance of the executive regulations of Law 151/2019;
• Law 48/1941 on the suppression of fraud, as amended, most recently by Law 281/1994;
• Law 15/2017 on the facilitation of procedures for granting licences to industrial facilities and its executive regulations;
• Law 214/2020 on the regulation of clinical medical research and its executive regulations;
• Law 8/2021 on the regulation of blood operations and the collection plasma to manufacture its derivatives and export them and its executive regulations; and
• regulatory guidelines issued by the EDA.

(b) Medical devices

Medical devices are regulated by the:

• guidelines and regulations issued by the EDA.

1.2 Which bodies are responsible for enforcing the applicable laws and regulations? What powers do they have?

EDA: The EDA is the main pharmaceutical regulatory body in Egypt, replacing the Ministry of Health since the enactment of Law 151/2019. The EDA is mainly responsible for:

• the registration and pricing of:
• • pharmaceutical products;
  • medicines;
  • medical plants;
  • cosmetics;
  • raw materials;
  • insecticides; and
  • products of natural origin;
• the inspection of pharmacies and manufacturing facilities; and
• the issuance of marketing authorisations and licences.

The Central Administration of Medical Devices, a unit operating under the EDA, runs all regulatory processing with respect to medical devices.

As the main regulator, the EDA holds both regulatory and executive powers.

• Regulatory powers:
• • To develop policies to ensure the availability, quality and safety of pharmaceutical and medical products;
  • To review and update regulations to meet health, safety and international standards;
  • To coordinate with the General Authority for Industrial Development on land allocation for factories;
  • To set licensing requirements for laboratories and facilities to ensure conformity and safety;
  • To establish procedures for the inspection, import/export, registration, pricing and supervision of pharmaceuticals and medical products;
  • To implement binding systems to track and ensure the quality of products across their lifecycle; and
  • To develop training programmes to enhance staff skills and efficiency.
• Executive powers:
• • To enforce laws and regulations relating to the registration, pricing and control of pharmaceuticals, ensuring consumer protection;
  • To issue licences for pharmaceutical facilities in compliance with the law;
  • To evaluate and price pharmaceuticals according to approved standards;
  • To conduct tests and analyses to ensure product quality and compliance with legal requirements;
  • To oversee the circulation of locally manufactured and imported pharmaceuticals and medical products after required testing;
  • To maintain accurate databases and share information with local and international bodies;
  • To collaborate with universities and research centres on pharmaceutical research;
  • To educate consumers about pharmaceuticals and medical products in coordination with relevant authorities;
  • To evaluate clinical trial results for pharmaceuticals according to EDA procedures; and
  • To establish reference and specialised laboratories.

UPA: The UPA is a specialised medical procurement authority, established as a public economic authority reporting directly to the prime minister. It holds exclusive responsibility for managing the procurement of medical products on behalf of all government and public sector entities in Egypt. The UPA receives a fee of up to 7% of the value of the procured products from the requesting governmental and public entities in exchange for the procurement services that it provides. Therefore, governmental and public entities are prohibited from making direct purchases of any medical product, except in emergencies, which must be assessed and approved by the Cabinet of Ministers.

1.3 What is the general approach of those bodies in regulating the pharmaceutical and medical device sector?

Since its inception, the EDA has had the clear objectives of:

• strengthening compliance on the market; and
• improving Egypt's regulatory standing with the World Health Organization (WHO).

This focus on enhancing compliance has led to some market disruptions. However, the EDA's current approach now focuses on:

• engaging with market players;
• fostering collaboration; and
• taking a less aggressive stance in enforcing regulatory standards.

Additionally, while medical devices were previously unregulated, the EDA is increasingly introducing new regulations ensure safety and quality in the market.

1.4 What other industry codes of conduct or best practices are applicable to the production and distribution of (a) pharmaceuticals and (b) medical devices in your jurisdiction?

(a) Pharmaceuticals

• The Guidelines on Classification as Nonprescription Medicinal Products (OTC) (2021);
• The EDA Guidelines on Good Pharmacovigilance Practice in Egypt for Pharmaceutical Products (2023);
• The EDA Guidelines on Good Regulatory Oversight of Clinical Trials by the EDA (2024);
• The Guidelines on Post Market Quality Monitoring of Biological Products in Egypt (2024);
• Ministerial Decree 435/2006 on Good Manufacturing Practices for Biopharmaceuticals and Vaccines;
• The draft EDA Guidelines on Good Manufacturing Practices for Pharmaceuticals (2022);
• The EDA Guidelines on Good Distribution and Storage Practices (2023);
• The Good Review Practice Guidelines Issued According to EDA Chair Decree 512/2022;
• The EDA Guidelines on Reliance Practices During Registration of Medicinal Products (2024);
• The Guidelines on the Assessment of Safety and Efficacy that Impact on the Withdrawal, Suspension or Revocation of Registration Procedures or Marketing Authorisation Licences (2023); and
• The EDA Guidelines on the Detection and Reporting of Adverse Reactions for Pharmaceutical Products and Medical Devices (2023).

(b) Medical devices

• The EDA Guidelines for Preclinical Testing and Clinical Investigation for Medical Devices (2024);
• The Good Review Practice Guidelines Issued According to EDA Chair 512/2022;
• The Guidelines on the Medical Device Vigilance System of the Medical Device Safety Department, Central Administration for Pharmaceutical Affairs, Ministry of Health and Population (2013); and
• The Regulatory Guidelines on the Issuance of Import Approvals of All Types of Medical Devices (2022).

2. Manufacturing permit

2.1 What government permits are required to manufacture pharmaceuticals and medical devices in your jurisdiction? Do any exemptions apply?

In order to manufacture a pharmaceutical product or medical device, the manufacturer must first obtain a licence from:

• the Egyptian Drug Authority (EDA); and
• the Industrial Development Authority (IDA).

There are no exemptions from this requirement under Egyptian law.

2.2 What are the key features of such permits?

The requirements to obtain such permits include:

• compliance with good manufacturing practices;
• the submission of a comprehensive application to the IDA and EDA with the essential documents outlined in question 2.3; and
• a thorough evaluation and joint inspection by the IDA and EDA to verify compliance with regulatory standards.

2.3 What are the procedural and documentary requirements to obtain such permits? What restrictions apply to applicants?

The procedure for obtaining a permit for the manufacture of pharmaceuticals and medical devices is handled through collaboration between the EDA and the IDA. The application process includes the following steps:

• Submission of the application by the manufacturer: The manufacturer must submit an application to the IDA specifying the type of factory that requires a licence, accompanied by the necessary documents, including:
• • the land allocation decree; and
  • the engineering drawings.
• Review by the IDA: The IDA will forward the application to the General Administration of Factory Licences (GAFL) at the EDA for review.
• Joint inspection: A joint inspection will be concluded by representatives of both the IDA and the EDA.
• Further requirements: After obtaining the licence from the IDA, the manufacturer must submit additional documents to the GAFL via a designated Google Drive link in order to obtain a factory data certificate.

Furthermore, the IDA has set out the following additional requirements for the manufacture of medical devices:

• The factory should have its own independent entrances and exits.
• No factory within a multi-storey industrial complex will be approved if any steps are taken in an air-classified area.
• The factory must have a clear sign bearing its name.
• The height between the factory floor and the lower surface of the ceiling lining should not be less than 2.6 metres.
• The ground floor of the spring must be at street level or higher, apart from sufficient precautions needed to prevent water from leaking into the ground floor where this is lower than the street level, including the creation of a drainage network at an appropriate distance so that it does not become a source of pollution.
• The factory must have an uninterrupted power supply for operations or steps that require a continuous power supply.
• A separate production area must be provided for medical supplies in the event of another industrial activity (in the case of non-sterile medical supplies).
• The requirements relating to security, safety, occupational health and prevention of fire hazards set out in Decree 864/2018 must be met.

2.4 What does the permitting process involve? How long does it typically take? What costs are incurred?

The permit process involves the following steps:

• submitting an application to the IDA;
• submitting the required documents;
• obtaining advance approval from both the EDA and the IDA and their internal relevant administrations;
• complying with the rules on pharmacovigilance; and
• obtaining the necessary technical operational licences.

The IDA's inspection must take place within 90 days of submission of the application form. The IDA allows a 180-day grace period for facilities to rectify any violations of the above requirements.

As per Law 151/2019 and its executive regulations, the licensing and commissioning fees for factory licensing are capped at EGP 10,000. However, in practice, such costs may vary.

2.5 What are the ongoing rights and obligations of the permit holder? How is compliance monitored? What penalties may be imposed for breach?

Permit holders have the right to:

• manufacture pharmaceuticals and medical devices; and
• trade, sell or market them as per the EDA's guidelines.

Permit holders must:

• obtain the necessary approvals;
• adhere to good manufacturing practices; and
• notify the IDA and EDA of any changes to the factory.

The EDA has set strict guidelines to monitor compliance through the Central Administration for Drug Control Guides, which monitors the quality control laboratories of pharmaceutical companies, setting:

• guidelines for the technical assessment of finished products for human use; and
• proficiency testing programmes and laboratory testing programmes.

According to Article 81 of the Pharmacy Practice Law (127/1955), anyone that trades or manufactures pharmaceuticals or medical devices without the prior approval of the EDA will be subject to a fine of between EGP 20,000 and EGP 50,000.

2.6 For how long is the permit valid? Are variations to the permit terms possible? How is the permit renewed?

The IDA has specified that licences are indefinite; only a yearly inspection of the factory by the IDA is required to maintain them. However, a licence must be renewed if the holder carries out any expansions or substantial modifications that may alter the specifications based on which the licence was initially granted. The IDA also requires renewal if:

• the factory is relocated;
• the purpose of the factory changes to the production of something other than the product(s) based on which the licence was initially granted; or
• any administrative changes are made to the factory.

2.7 Can a permit be transferred? If so, what is the process for doing so?

A permit can be transferred with the approval of the EDA. An ownership transfer request must be submitted to the GAFL for review.

3. Clinical trials

3.1 Which legislative and regulatory provisions govern clinical trials for (a) pharmaceuticals and (b) medical devices in your jurisdiction?

Clinical trials in Egypt are governed by:

• the Clinical Trials Law (214/2020) and its executive regulations (Regulation 927/2022); and
• other relevant guidelines and decrees published by the Egyptian Drug Authority (EDA).

3.2 What ethical requirements apply to clinical trials in your jurisdiction?

In Egypt, the ethical requirements for clinical trials are set out in the Clinical Trials Law, which is enforced by:

• the Institutional Committee for the Review of Medical Research Ethics;
• the EDA;
• the Supreme Council for the Review of Medical Clinical Research Ethics; and
• the General Intelligence Authority.

These requirements align with international standards, including the Declaration of Helsinki and Good Clinical Practice.

A core requirement in clinical trials is informed consent. The participants/subjects must be adequately informed about the clinical trial's objectives, procedures, potential risks and benefits prior to their participation. Consent must be given voluntarily and participants have the right to withdraw from the study at any time without facing any repercussions.

3.3 What consent requirements apply to clinical trials in your jurisdiction?

According to the Clinical Trial Law, informed consent is a necessary requirement. This means that participants in a clinical trial must voluntarily agree to participate, in writing, after being fully informed about all aspects of the research, including potential risks and benefits. If a participant is unable to provide consent, his or her legally authorised representative may do so on his or her behalf.

Subjects in a clinical trial have the right to withdraw from the study at any time, without giving a reason. They must be informed of any potential medical harms that may arise from withdrawing from the trial. Any contrary provisions in the informed consent templates are null and void.

Certain categories of individuals, known as 'vulnerable subjects', require extra protection in clinical research. These individuals have restricted autonomy due to legal, mental or health constraints, making them more susceptible to coercion or manipulation. In such cases, informed consent must be obtained from their parent, guardian or authorised representative.

3.4 What reporting requirements apply to clinical trials in your jurisdiction?

The principal investigator is obliged to notify the relevant parties – including the research sponsor, the Institutional Committee for the Review of Medical Research Ethics, the EDA and the Supreme Council – of:

• the occurrence of any adverse events; and
• the actions taken to protect participants.

These notifications must be made within a maximum period of 24 hours.

3.5 What steps does the clinical trial process typically involve?

The Clinical Trials Law sets out the stages of clinical trials and ethical requirements aimed at protecting subjects. Clinical trials must be preceded by pre-clinical research which is approved in writing by the EDA.

A protocol must be put in place and approved by:

• the Institutional Committee for the Review of Medical Research Ethics;
• the EDA; and
• the Supreme Council.

This protocol is required for clinical trials involving novel biological compounds, indications, formulations or medical devices that:

• have not previously been used in humans; and
• lack international approval.

The approval of the General Intelligence Authority must be obtained if the research is conducted with foreign entities.

Clinical trials proceed as follows:

• Phase I: This involves a small group (20-80 participants) – either healthy participants or patients – and aims to evaluate the safety of the treatment or medical device.
• Phase II: This involves a larger group (200 to 300 participants) and aims to assess the effectiveness and safety of the treatment or medical device.
• Phase III: The treatment or medical device is given to and used by large groups (hundreds to thousands) of patients in order to:
• • confirm its effectiveness;
  • monitor side effects; and
  • compare it to standard treatments.
• Phase IV: Studies are conducted with a large number of patients (several thousand) after the treatment or medical device has been offered on the market in order to:
• • collect information on the side effects associated with long-term use of the product; and
  • ensure the continuous safe use of the product.

3.6 How are clinical trials monitored in your jurisdiction?

Clinical trials in Egypt are monitored by different regulatory bodies which seek to ensure ethical and scientific compliance at multiple levels, such as:

• the Institutional Committee for the Review of Medical Research Ethics;
• the EDA;
• the Supreme Council; and
• the General Intelligence Authority.
  

3.7 What other best practices should be followed in relation to clinical trials?

Best practices for clinical trials in Egypt focus on:

• protecting participants;
• following ethical rules; and
• meeting legal requirements as set out in the Clinical Trials Law.

They include the following:

• All necessary approvals from the relevant authorities must be secured.
• International studies – especially those involving cross-border data sharing – require approval from the Egyptian Intelligence Authority.
• Informed consent and prompt reporting of adverse events are essential requirements.

4. Marketing authorisation

4.1 What are the procedural and documentary requirements to obtain marketing authorisation for (a) pharmaceuticals and (b) medical devices? What exemptions and/or restrictions apply?

(a) Pharmaceuticals

The procedures and documentation required to obtain a marketing authorisation (MA) for pharmaceuticals vary depending on factors such as:

• the pharmaceutical type (bulk, fully imported or locally manufactured); and
• the pharmaceutical category (medicinal, biological, biosimilar, innovative, veterinary or herbal).

Additionally, there are separate provisions governing the issuance of MAs for:

• cosmetics;
• pesticides; and
• disinfectants.

The procedure generally involves the submission of:

• a registration request;
• a trade name request;
• evidence of pharmaceutical vigilance;
• a quality module;
• bioequivalence and in-vitro dissolution studies;
• stability studies;
• inserts;
• mock-ups; and/or
• a final registration file.

A prerequisite for issuing an MA for imported human medical products is that the product must have been marketed for at least one year in:

• the country of origin; or
• an approved reference country.

In emergencies, a product may be offered on the market with exemptions from some conditions required for registration, subject to a detailed technical memorandum:

• prepared by the Central Administration of Pharmaceutical Products; and
• approved by the Egyptian Drug Authority (EDA) chair.

(b) Medical devices

The procedures and documents required for to obtain an MA for a medical device vary depending on:

• whether the medical device:
• • is locally manufactured;
  • holds international quality certificates; or
  • is imported;
• the nature of the medical device (eg, sterile, non-sterile, in-vitro diagnostic); and
• the device's classification.

Documents include:

• a declaration of conformity;
• a CE certificate;
• an ISO 13485:2016 certificate;
• a free sale certificate from a reference country, for devices classified as Class IIb or III; and
• a free sale certificate from the country of origin, for devices classified as Class IIa.

Guidelines issued by the EDA detail the necessary procedures and documents.

4.2 What steps does the process of obtaining marketing authorisation typically involve? How long does it take? What costs are incurred?

Pharmaceuticals: For pharmaceuticals manufactured or imported for local circulation, the applicant must submit an enquiry to the EDA on the availability of a place in the box of products with similar active pharmaceutical ingredients ('similars box'). EDA Decree 645/2018 lists some cases in which MAs can be issued even where no place is available in the similars box.

Once approved, the applicant must submit:

• suggested commercial names for the product; and
• the necessary documents for the pricing and pharmacovigilance file.

For locally manufactured pharmaceuticals, the applicant must produce a pilot batch for testing purposes. In the case of pharmaceuticals that are locally manufactured for export, the applicant must additionally submit a research and development batch for evaluation purposes. For imported pharmaceuticals:

• an analysis file must be submitted to the competent department; and
• samples must be tested by the EDA.

The timeframe for obtaining an MA is approximately three years. However, a fast-track registration system is available in certain cases. The fee for obtaining an MA ranges from EGP 15,000 to EGP 250,000.

Medical devices: For medical devices, the process for obtaining an MA involves:

• the electronic submission of a registration request;
• completion of the file according to the checklist;
• evaluation of the file by the competent department; and
• the issue of a registration licence.

It takes between six months and one year to obtain an MA for medical devices. The registration fee is:

• EGP 5,000 for local medical devices; and
• EGP 7,000 for imported devices.

In practice, the abovementioned timelines and costs may vary.

4.3 What are the ongoing rights and obligations of the marketing authorisation holder once the product has been placed on the market? How is compliance monitored? What penalties may be imposed for breach?

Once a product has been placed on the market, the MA holder has the right to sell, promote and market the product in Egypt. The MA holder:

• is responsible for the quality, safety and efficacy of the product throughout its lifecycle;
• must comply with all applicable laws, regulations, decrees and guidelines, including those on the compulsory pricing of pharmaceuticals, and submit studies required by the EDA in certain cases; and
• cannot change any aspect included in the MA – including the commercial name of the product, the dossier or the packaging – without obtaining the EDA's approval through the prescribed variation request process.

The EDA is responsible for monitoring the MA holder's compliance with applicable laws and regulations. This oversight can be conducted through various methods, including:

• site visits;
• inspections;
• random sample testing; and
• product recalls.

Depending on the nature of the violation, the penalties for non-compliance vary from fines to administrative sanctions, including:

• the confiscation of products;
• the closure of institutions; and/or
• revocation of the MA.

4.4 For how long is the marketing authorisation valid? Are variations to the terms possible? How is the marketing authorisation renewed?

Pharmaceuticals: An MA is valid for:

• 10 years for medicinal, herbal and veterinary products; and
• five years for biological and innovative products.

These timeframes begin to run from the date of issuance of the MA.

MAs for pharmaceuticals must be renewed in the 12 months before they expire; otherwise, the MA will be cancelled. The renewal procedure requires the submission of a request to the Central Administration of Pharmaceutical Products. If the MA holder exceeds the specified period for submitting the renewal application, the application must be reviewed by the EDA chair on a case-by-case basis.

Upon obtaining preliminary approval for renewal, an MA holder will be granted a grace period of up to four years from the date of expiry of the MA to complete the necessary technical studies, requirements and approvals for renewal of the MA. During this period, the product may be imported, manufactured and marketed in accordance with the law. The EDA has issued detailed guidelines on renewal documents and procedures.

Medical devices: An MA is valid for:

• 10 years for imported and local medical devices that have international quality certificates; and
• five years for locally manufactured medical devices that do not have international quality certificates.

These timeframes begin to run from the date of issuance of the MA.

MAs must be renewed on submission of a request to the Central Administration for Medical Devices in the 12 months before they expire.

Variations to the terms of the MAs for pharmaceuticals and medical devices are permitted, provided that certain procedures and documents are satisfied.

4.5 Can a marketing authorisation be transferred? If so, what is the process for doing so?

Yes, MAs can be transferred with the approval of the EDA. The MA holder must submit a variation request to the EDA. The relevant variation unit will:

• review and evaluate the variation request; and
• inform the MA holder of whether the variation is approved or rejected.

Transferring or changing the MA to a different entity requires:

• the submission of relevant documents; and
• fulfilment of the following requirements:
• • amendment of the relevant section(s) of the dossier concerning the change for pre-qualified quality products; and
  • amendment of the product information (ie, the inner leaflet and mock-up), which will be followed up by the Central Administration of Operation (Inspection Department).

The variation guidelines are updated regularly by the EDA.

5. Specific types of products

5.1 What specific provisions and requirements apply to the following types of products in your jurisdiction?

(a) Biologicals and biosimilars

The registration requirements for biologicals and biosimilars are governed by Egyptian Drug Authority (EDA) Decree 343/2021.

The marketing authorisations (MAs) for these products are valid for five years and must be renewed in the 12 months before expiry. The MA will be cancelled if the product is not offered on the market continuously for a period of one and a half years after the issuance of the MA.

(b) Controlled substances

The Anti-narcotics Law (182/1960) regulates these products. It prohibits trading in narcotics except in specified exceptional cases. The prior written approval of, and a licence from, the EDA are required to export or deal in narcotics. The list of controlled substances is set out in a table attached to the law, which can be amended by the chair of EDA.

Moreover, psychiatric medicines are specifically regulated by Ministry of Health Decree 172/2011. Such medicines are distributed solely by the Egyptian Pharmaceutical Company for Pharmaceutical Trading.

(c) Orphan drugs

There are no specific provisions that regulate orphan drugs in Egypt. These medications are subject to the general regulations governing pharmaceuticals.

(d) Paediatric medicines

There are no specific provisions that regulate paediatric medicines in Egypt. These medications are subject to the general regulations governing pharmaceuticals.

(e) Traditional and complementary medicines

Traditional and complementary medicines are regulated by EDA Decree 572/2022 on the Registration of Complementary Medical Products and its guidelines.

MAs for these products are valid for 10 years, subject to renewal. An MA will be cancelled if the product has not been continuously marketed for a period of one and a half years after the issuance of the MA.

6. Packaging and labelling

6.1 What regulatory provisions and requirements apply to the packaging and labelling of (a) pharmaceuticals and (b) medical devices? Do these vary depending on the type of product? What exemptions and/or restrictions apply?

(a) Pharmaceuticals

The packaging and labelling of pharmaceuticals are subject to various regulations, including:

• the Pharmacy Law; and
• the Egyptian Drug Authority (EDA) Guidelines on the Mock-up Design of Human Pharmaceutical Products.

The EDA guidelines provide for no exemptions in relation to packaging and labelling.

The Pharmacy Law highlights the key information that should be clearly visible on a pharmaceutical product, such as:

• the product name;
• the active ingredient;
• the manufacturer's details;
• instructions for use; and
• the EDA registration number and year of registration.

The EDA Guidelines on the Mock-up Design of Human Pharmaceutical Products set out the following conditions that must be fulfilled by, and information that must be included in, the packaging and labels of pharmaceutical products to be approved for the Egyptian market:

• The product name, strength and dosage form, manufacturing and expiration dates, licence holder name or logo and public price should be prominently displayed.
• The container label and carton labelling should not look similar across different strengths of the same products.
• Abbreviations or symbols should be avoided for clarity.
• The design of the label and packaging should not convey conflicting messages.
• The text should be clearly legible; capitals and italics are not recommended.
• If the dosage form or the product relates to a special population (eg, infants, children, adults, men, women), this should be mentioned.
• The storage conditions as determined by the approved stability study should be specified.
• Statements reading "Keep out of the reach of children" and "For more information, see the enclosed leaflet" should be included.
• Any special precautions for handling (eg, shaking, dilution) should be specified.
• Other contents of the package should be mentioned on the outer label (eg, measuring cup, applicator, dropper, syringe, calibrating dropper).
• All information should be in English and Arabic.

(c) Medical devices

The labelling of medical devices must adhere to specific regulatory requirements, including the EDA Guidelines on the Labelling Requirements for Medical Devices, Medical and Laboratory Equipment and In Vitro Diagnostics, Components and Production Inputs.

The labels of medical devices must include the following information:

• the trade name (if applicable);
• the product name;
• the product code, model or reference number;
• the batch number or serial number (if necessary);
• any special handling precautions (if applicable);
• any special storage precautions (if applicable);
• an indication of single use (for single-use medical supplies);
• the expiry date in an accepted format, clearly indicating the product's lifespan (eg, "Expires 12/2025") or manufacturing date and shelf life (eg, "Manufactured 12/2025. Shelf life: 3 years");
• the factory name and address;
• the country of origin; and
• the importer or agent details (if the medical device is imported).

The data should also be written (at minimum) in a clear and stable manner that is difficult to remove, erase or obliterate throughout the validity period of the medical device.

The packaging and labelling conditions vary depending on the type of pharmaceutical product or medical device.

6.2 How is compliance with these provisions and requirements monitored? What penalties may be imposed for breach?

The provisions and requirements are monitored by the EDA. In case of non-compliance, the EDA will not approve the products or release them onto the market.

6.3 What other best practices should be followed in relation to the packaging and labelling of (a) pharmaceuticals and (b) medical devices?

The EDA has announced plans to digitise pharmaceutical information leaflets. According to the EDA, future medicine packaging will include a QR code, which will enable users to quickly and accurately access all relevant information about each drug.

7. Advertising and promotions

7.1 What regulatory provisions and requirements apply to the advertising and promotion of (a) pharmaceuticals and (b) medical devices? How do these vary depending on: (a) The type of product? (b) The target (ie, healthcare professionals or consumers)? and (c) Whether the activity takes place online or offline?

The promotion and advertising of pharmaceuticals and medical devices are mainly regulated under:

• Law 206/2017 on the promotion of healthcare products and services; and
• Egyptian Drug Authority (EDA) Decree 590/2021 Issuing Guidelines on Online Promotional, Educational and Awareness Materials and Activities.

The approval of the EDA is required before any advertising or marketing materials are published. According to the EDA, the scientific department of the marketing authorisation holder is responsible for applying for such approval.

(a) Type of product

Prescription-only pharmaceutical products: The advertising and promotion of prescription-only medicines that target patients and the public are not allowed. However, promotional materials aimed at healthcare professionals are permitted, provided that they comply with EDA requirements.

Over-the-counter products: Promotional materials for can target the public since these products do not require a prescription. Promotions can also target health professionals in accordance with EDA requirements.

(b) Target

The EDA guidelines regulate the advertising and promotion of pharmaceutical products targeting health professionals and the public, with different requirements applicable to each.

(c) Whether the activity takes place online or offline

EDA approval is required for certain types of promotional materials, whether online or offline. Some technical requirements apply with regard to online content.

7.2 What safeguards are in place to prevent inducements from being offered to healthcare professionals to promote the use of specific pharmaceuticals or medical devices?

Gifts to healthcare professionals are permitted as long as they adhere to the Medical Profession Code of Ethics. Among other things, this requires that gifts:

• be modest;
• be relevant to the recipient's professional practice; and
• not exert undue influence or compromise the impartiality of prescribing decisions.

No gifts should aim to incentivise the prescription of specific products over the patient's best interests. Further, EDA regulations require that promotional materials and activities targeting healthcare professionals be reviewed and approved before use to ensure that the content is factual and unbiased.

7.3 What provisions and requirements apply to the promotion of off-label use?

According to the Guidelines for Online Promotional, Educational and Awareness Materials and Activities, the promotion of off-label use is not allowed

7.4 How is compliance with these provisions and requirements monitored? What penalties may be imposed for breach?

The General Administration for Regulation of Marketing and Advertising Materials (RMA) at the EDA:

• conducts periodic random monitoring across online platforms to identify any violations; and
• addresses complaints regarding potential breaches.

Upon detecting a violation, the RMA issues an attention letter, warning letter or red-flag letter, depending on the severity of the case, outlining the corrective actions required. In instances of non-compliance or repeat violations, precautionary measures will be enforced against all involved parties in accordance with applicable laws and decrees issued by the EDA chair.

7.5 What other best practices should be followed in relation to the advertising and promotion of (a) pharmaceuticals and (b) medical devices?

Companies must account for the timelines required to secure approval from the Egyptian Drug Authority (EDA) when planning marketing campaigns. Additionally, there is a growing trend to leverage new technologies and social media platforms to execute marketing strategies and enhance communication with healthcare professionals. This is reflected in the new guidelines of the EDA on online advertising and awareness campaigns.

8. Product liability and safety

8.1 What regulatory provisions and requirements apply to the safety and quality of (a) pharmaceuticals and (b) medical devices in your jurisdiction?

As per Law 151/2019, the Egyptian Drug Authority (EDA) is responsible for regulating, supervising and verifying the quality, efficacy and safety of pharmaceuticals and medical devices. The EDA has the authority to:

• ban the circulation of any pharmaceutical that is harmful to public health;
• cancel its marketing authorisation (MA); and
• confiscate existing quantities thereof.

The following regulations apply to the safety of pharmaceuticals:

• The Guidelines on Good Pharmacovigilance Practice and the Guidelines on the Vigilance System, issued by the EDA, require marketing authorisation (MA) holders to have a pharmacovigilance and medical device vigilance system in place for pharmaceuticals and medical devices respectively, separate from their obligation to detect and report adverse effects.
• EDA Chair Decree 450/2023 stipulates that a report on the safety, quality and efficacy of a registered pharmaceutical must be submitted in the fifth year of the MA validity period.
• Minister of Health Decree 540/2007 and EDA Decree 146/2022 regulate the recall of pharmaceuticals and applicable circulation bans.

The Guidelines on Adverse Reaction Detection and Reporting provide that any suspected adverse reaction from pharmaceuticals should be reported by healthcare professionals, patients or MA holders to the Pharmaceutical Vigilance Centre. Safety issues with medical devices should be reported to the Medical Device Safety Unit by:

• manufacturers;
• healthcare professionals; or
• any relevant person.

8.2 What is the typical process for conducting product recalls in your jurisdiction? Are these generally voluntary or mandatory?

Recalls may take place at any time in the production process.

Recalls may be mandatory in case of deficiencies related to quality, efficacy or safety. In this respect, a rapid alert system relating to the recall or withdrawal should be implemented, to issue urgent and serious alerts. Urgency in this regard is classified based on the relevant risk (eg, life threatening/could cause illness/violates labelling or manufacturing guidelines).

Recalls may also be voluntarily initiated by a MA holder as a result of an abnormal quality-related observation. After conducting the relevant risk assessment, the EDA will publish the recall on its website to notify the public accordingly.

The mandatory recall action process mainly comprises the following:

• an initiation phase for:
• • identification of the problem;
  • risk assessment;
  • decision making on whether to recall; and
  • planning for the recall;
• an implementation phase for the recall action notice issuance and the requested recall action execution; and
• a review phase for monitoring and reviewing the effectiveness of the recall action.

In case of mandatory recalls, a prior investigation is conducted by the EDA to determine the need for the same.

Recalled products will be destroyed to prevent them from re-entering the market. This is why an official unit is responsible for the recall follow-up and disposal of all unwanted medical products.

8.3 What reporting requirements apply to product recalls in your jurisdiction?

MA holders, applicants, manufacturers, importers, distributors and pharmacies must report to the EDA any defect in a medicinal product that could result in a recall or an abnormal supply restriction. If one or more batches of the product were imported into the Egyptian market, the MA holder must report any alerts related to product defects or enforcement taken in this regard.

MA holders and suppliers should have systems and procedures in place:

• to investigate, review and report product defects to the EDA; and
• if necessary, to promptly recall defective products.

In case of a product recall, the MA holder must follow up and notify:

• the concerned authorities;
• the supply chain; and
• customers.

If the recalled batches or products have been exported by the MA holder, it must:

• notify the importing entity of the recall; and
• provide proof of receipt to the EDA.

Defects in the above context include:

• faulty manufacture;
• product deterioration;
• detection of falsified medicines;
• any other serious quality problems with a product; and
• quality defects in active pharmaceutical ingredients.

Further, under the Consumer Protection Law (181/2018), suppliers of products, including manufacturers, must report to the Consumer Protection Authority any defect in a product and the potential harm it may cause within seven days of the date on which it identifies or learns of the defect. If the defect is expected to harm consumer health or safety, this notification must be provided immediately and the supplier must warn consumers, through the media, not to use the product.

8.4 What other best practices should be followed with regard to product recalls in your jurisdiction?

The current legal framework for pharmaceutical product recall in Egypt is robust and comprehensive – especially since the issuance in 2024 of the Guidelines on Recalls and Rapid Alert Systems for Medicinal Products, which set out comprehensive provisions on:

• the reporting of defective products;
• recall types;
• recall classification;
• appeals; and
• implementation of recalls.

Further areas for development might include establishing a more advanced tracking system for registered pharmaceuticals to facilitate a conclusive on-ground recall execution process.

8.5 What regulatory provisions and requirements apply to medical product liability in your jurisdiction?

Under Article 163 of the Civil Code, anyone that intentionally or negligently causes harm or injury to another will be liable for compensation upon proof of causation between the act and consequential harm or injury in question.

Article 67 of the Commercial Law provides that the manufacturer or distributor of a product will be liable to anyone that suffers physical or material damage caused by such a product upon proof of the link between the damage and a defect in the product.

Articles 2, 19 and 70 of the Consumer Protection Law:

• prohibit activities that could violate consumers' fundamental rights, including the rights to health and safety; and
• provide for fair compensation for damages resulting from the purchase or use of products.

The penalties imposed on suppliers in case of failure to comply with the obligation to recall defective products include:

• fines ranging from EGP 50,000 to EGP 2 million; and
• imprisonment and fines ranging from EGP 100,000 to EGP 2 million where the violation exposes consumers to danger or the risk of an incurable disease.

Further criminal liability arises under:

• Articles 238 and 244 of the Penal Code if the product causes injury, disability or death; and
• Articles 2, 3bis, 4 and 6bis of the Law on the Suppression of Fraud and Deception (48/1941) if the product is counterfeit, corrupted or expired.

8.6 What are the respective liabilities of the various parties in the supply and distribution chain under this regime?

Suppliers under the Consumer Protection Law include, among others:

• producers;
• manufacturers;
• importers;
• distributors; and
• sellers.

Under the Consumer Protection Law, a manufacturer will be liable for any damage caused by a product that results from a defect in that product. Also, the supplier will be liable for any damage caused by the product if this resulted from the supplier's failure to:

• take reasonable precautions to prevent such damage; or
• warn against the possibility of such damage.

Further, the distributor or seller will be liable for any damage caused by the product that results from a defect attributable to the way in which the product was:

• prepared for consumption;
• stored;
• packaged;
• handled; or
• displayed.

In all cases, the liability of suppliers will be joint.

Pursuant to Article 67 of the Commercial Law, manufacturers, importers and distributors will be liable for damage arising from the use of defective products. A product is 'defective' if adequate precautions were not considered in, among other things, its:

• design;
• manufacture;
• assembly;
• storage; or
• packaging.

Any condition or statement that aims to exempt the manufacturer or distributor from liability or limit that liability will be deemed null and void. Additionally, a consumer who suffers damage may file a claim against the manufacturer, distributor or both.

Lastly, criminal liability arises:

• in case of:
• • counterfeiting; or
  • the sale, offering for sale or import of counterfeit, corrupted or expired pharmaceuticals; or
• where a product causes injury, disability or death.

8.7 Who has standing to bring a medical product liability claim in your jurisdiction? What is the process for bringing a claim?

Under the Commercial Law, a consumer who suffers damage may file a claim against the manufacturer, the distributor or both.

The affected party may file a claim under:

• the Civil Code;
• the Consumer Protection Law;
• the Penal Code; and
• the Law on the Suppression of Fraud and Deception.

A medical product liability claim must be filed before the competent court like any other civil claim.

Generally, a civil claim is barred by limitation after the earlier of:

• three years from the claimant's knowledge of the damage in question; or
• 15 years from the occurrence of the damage.

This does not apply where a relevant criminal case relating thereto has been filed and remains pending after these timeframes have elapsed.

In criminal liability cases, the general rule is that the public prosecutor will:

• review complaints submitted by a claimant; and
• if sufficient evidence exists, initiate legal proceedings against the defendant.

The case is then referred to the competent court and the defendant will be summoned to appear before the court.

8.8 What defences to medical product liability claims are available in your jurisdiction? Can liability be limited?

In civil liability claims, defences may be based on proving the absence of key elements for civil liability, including:

• the default;
• the damage; and/or
• the causal link between the default and damage in question.

Further, defendants may invoke the statute of limitations, where applicable.

Any condition or statement that seeks to exempt a manufacturer or distributor from liability or limit that liability will be deemed null and void.

In criminal liability claims, defences may be based on proving, for instance, the absence of:

• a criminal offence; and/or
• knowledge or negligence, where this is required for the relevant act to constitute a crime.

Further, defendants may invoke the statute of limitations, where applicable.

Criminal penalties are public policy related. Thus, criminal liability is unlimited.

In practice, pharmaceutical companies may strengthen their defence based on the EDA's documented approvals and ongoing supervision.

8.9 What remedies can claimants seek? Are punitive damages available?

Except in criminal liability claims, the remedies sought are financial remedies against the material and moral damage incurred. Punitive damages are not recognised in Egypt. The damages recognised under the Egyptian legal regime are of a compensatory nature only.

9. Sale and distribution

9.1 What regulatory provisions and requirements apply to the dispensing, sale and distribution of (a) pharmaceuticals and (b) medical devices? How do these vary depending on:

• The Pharmacy Law;
• Minister of Health Decree 25/2009 on pharmaceutical warehouse licensing;
• The Law on Compulsory Pricing and Profit Limitation (163/1950), as amended by Minister of Supply Decree 38/1959;
• Minister of Health Decree 499/2012 on mandatory profit margins for distributors and pharmacists ('Pricing Decree');
• Law 151/2019 on the establishment and regulation the EDA and UPA; and
• Minister of Health Decree 78/2008 on the circulation of pharmaceuticals and medical devices.

Pharmaceuticals and medical devices may be traded only with the Egyptian Drug Authority's (EDA) approval. 'Trading' in this context includes producing, importing, exporting, distributing, dispensing, selling, storing, using, packaging, delivering or transferring pharmaceuticals and medical devices.

According to the Pharmacy Law, pharmaceuticals and medical devices may be made available only through 'pharmaceutical institutions', as defined under the Pharmacy Law, which mainly include:

• public pharmacies;
• private pharmacies;
• pharmaceutical manufacturing facilities; and
• pharmaceutical warehouses.

Further, pharmaceuticals must be solely distributed by authorised warehouses licensed by the EDA. The EDA sets out certain specifications in relation to such warehouses.

Human pharmaceuticals are subject to compulsory pricing at each level of the supply chain until they reach the patient. The Egyptian government imposes mandatory profit margins on distributors and pharmacists.

The Authority for Unified Procurement, Medical Supply and Technology Management is responsible for managing the procurement of medical products on behalf of all government and public sector entities in Egypt.

How do these vary depending on:

(a) The type of product?

The above provisions are applicable to all pharmaceuticals and medical devices.

However, some vaccines – including, without limitation, anti-rhesus vaccines – are provided exclusively through the Holding Company for Biological Products & Vaccines. Further, psychiatric medicines are solely distributed by the Egyptian Pharmaceutical Company for Pharmaceuticals Trading.

(b) The target (ie, healthcare professionals or consumers)?

Pharmaceuticals and medical devices may be made available only through pharmaceutical institutions. The supply chain starts from the marketing authorisation holder and moves to distributors, then public and private pharmacies, where consumers ultimately purchase the product. Thus, healthcare professionals are not part of the supply chain. In their capacity as such, healthcare professionals can receive free samples of pharmaceuticals and medical devices as part of promotional activities.

(c) Whether the activity takes place online or offline?

The online trading of pharmaceuticals and medical devices is not yet regulated in Egypt. However, the provisions governing the dispensing, sale and distribution outlined in this question are applicable to both offline and online sales.

9.2 How is compliance with these provisions and requirements monitored? What penalties may be imposed for breach?

The EDA monitors compliance with these provisions and requirements through its regulatory and executive powers as outlined in question 1.2. EDA officials have judicial seizure powers.

The penalties for breach include:

• fines;
• administrative closure;
• confiscation of products; and
• imprisonment.

For instance, Article 80 of the Pharmacy Law provides that anyone who operates a pharmaceutical institution without a licence will be penalised with:

• imprisonment for a minimum of one year; and
• a fine of between EGP 5,000 and EGP 10,000.

The institution's administrative closure will also be ordered.

Additionally, Article 81 of the Pharmacy Law penalises the sale, offering for sale or trading of any pharmaceuticals or medical devices which are not officially authorised for trading with a fine of between EGP 20,000 and EGP 50,000.

Violations of Decree 25/2009 regulating warehouse licensing are penalised by:

• the administrative closure of the entity in question; and
• the confiscation of products.

Finally, violation of compulsory pricing set by law could lead to:

• criminal and financial liabilities, such as:
• • imprisonment for one to five years; and
  • a fine; and
• confiscation of the products in question.

9.3 What other best practices should be followed in relation to the advertising and promotion of pharmaceuticals and medical devices?

Please see question 7.5.

10. Price regulation

10.1 How are the prices of (a) pharmaceuticals and (b) medical products regulated in your jurisdiction?

(a) Pharmaceuticals

Pharmaceutical pricing is governed by:

• the Law on Compulsory Pricing and Profit Limitation (163/1950), as amended by Minister of Supply Decree 38/1959; and
• Minister of Health Decree 499/2012 on mandatory profit margins for distributors and pharmacists ('Pricing Decree').

The Pricing Decree imposes mandatory profit margins at each level of the supply chain that must be reflected in the final sale price of the product.

In light of the above, a Pricing Committee established by the Egyptian Drug Authority (EDA) sets the prices of pharmaceuticals, applying an external reference pricing system. Under this system, the price of pharmaceuticals in Egypt is set based on the lowest price available in certain reference countries. The pharmaceutical's pricing certificate is valid for five years, after which the marketing authorisation (MA) holder must submit a re-pricing request at least three months before the validity term ends.

The mechanism in the Pricing Decree differs between innovator and generic pharmaceuticals. The mechanism for innovators is based on the lowest sale price in reference countries, while generics are priced at a lower price than innovators according to certain percentages specified in the Pricing Decree.

Finally, the Pricing Decree allows for a review of the price of pharmaceuticals in the following cases:

• There are currency fluctuations of 15% on average in one year (based on the Central Bank of Egypt's exchange rate); or
• A pharmaceutical company requests a reassessment of the pricing of its registered pharmaceuticals, capped at 5% of such pharmaceuticals per year, to be evenly divided on a quarterly basis.

(b) Medical devices

No explicit provisions govern the pricing of medical devices. However, in practice, if a medical device is closely intertwined with a pharmaceutical so that they constitute one single product, they will be priced as a pharmaceutical and will be subject to compulsory pricing.

There are no regulations setting out a pricing mechanism for medical devices. The current practice is that the prices of medical devices are set by the MA holder and submitted to the EDA for approval.

10.2 Does the government subsidise the cost of pharmaceuticals and medical devices in your jurisdiction? If so, what is the process for doing so?

Under Minister of Health Decree 290/2010, as amended, state-funded medical treatment is designed for the benefit of Egyptian citizens who do not qualify for any form of public or private health insurance. Specific procedures, eligibility requirements and financial limits (within the framework of the government's annual health budget allocated for these purposes) apply to the receipt of such treatment, which includes, without limitation, the necessary pharmaceuticals and medical supplies.

Certain medical conditions are prioritised for treatment under this system, including:

• cancer (malignant tumours);
• heart disease;
• kidney failure;
• hepatitis;
• diabetes and hypertension; and
• emergency cases.

The Egyptian government indirectly subsidises the cost of pharmaceuticals by imposing compulsory pricing along with a specific pricing review mechanism (see question 10.1).

Financial patient support programmes (PSPs) are regularly launched in Egypt in relation to pharmaceuticals, with the aim of lessening the financial burden on patients. These financial PSPs are authorised by the EDA through their inclusion in the pricing certificate for the relevant pharmaceutical. Financial PSPs are not yet heavily regulated under Egyptian law, although related regulations are anticipated in the near future.

Egypt introduced an obligatory universal health insurance system in 2018. This system is designed to provide comprehensive and equitable healthcare coverage to all Egyptians, regardless of their socioeconomic status. Its coverage is from birth to death, with no age restrictions, including essential medical services such as:

• consultations;
• diagnostic tests; and
• specialised treatments.

It operates on a social solidarity basis, with the government covering the costs for those who are unable to pay premiums. Private sector employees and self-employed individuals are also eligible to join voluntarily.

The system in question is being implemented in phases across six geographic regions in advance of a national rollout. This gradual implementation will allow for challenges to be addressed and the system to be refined before full-scale implementation by 2030. at

Lastly, under Law 67/2016, Presidential Decree 69/2015 and EDA guidelines, the Egyptian government offers various tax and customs exemptions in the medical and pharmaceutical sectors, particularly for:

• raw materials;
• packaging; and
• active pharmaceutical ingredients.

Pharmaceutical companies involved in the import and production of medical products can benefit from these exemptions as long as they:

• follow the required procedures; and
• meet the relevant regulatory requirements.

11. Import and export

11.1 What requirements and restrictions apply to the import and export of (a) pharmaceuticals and (b) medical devices in your jurisdiction?

Imports: The importation of human pharmaceuticals is regulated by Egyptian Drug Authority (EDA) Chair Decree 444/2023. This decree also apply to the import and customs clearance procedures for:

• active and inactive raw materials;
• packaging materials; and
• related chemicals.

The import of pharmaceuticals and their raw materials requires that the imported products have been registered or be pending registration with the EDA. Unregistered medical and biological products may be imported under certain conditions, such as where:

• equivalent registered products are not available in the local market; or
• the available quantities of such products are insufficient to meet needs, as confirmed by the EDA.

Imports must be from reference countries; if registered equivalents cannot be found in reference countries, imports may be allowed from non-reference countries, provided that all necessary requirements to ensure quality, safety and efficacy are fulfilled.

Companies that import pharmaceuticals must be registered with the EDA.

The import of medical devices also requires the approval of the EDA. Certain medical devices (with a higher risk category) may require further testing and medical devices from non-reference countries (countries not listed as recognised by the EDA) may face additional scrutiny or restrictions.

Exports: The export of medical devices, medical supplies and human pharmaceuticals requires approval from the Export Support and Monitoring Department of the EDA. This requirement applies to both finished products and bulk supplies intended for local distribution or export. However, items that have previously received manufacturing approval from the EDA are exempt from this requirement.

In the case of pharmaceuticals listed in the schedules attached to the Narcotics Control Law (182/1960), an export permit will be issued by the Import and Narcotics Release Department, followed by an export approval from the Export Support and Monitoring Department.

11.2 Are parallel imports permitted in your jurisdiction?

Parallel imports of pharmaceuticals are not permitted in Egypt. The EDA regulations stipulate that:

• all pharmaceutical products must be imported through authorised channels;
• all imports must have the prior approval of the EDA; and
• any importer of a pharmaceutical/medical device must be registered in the special importers' register at the EDA.

11.3 What other issues from an import and export perspective should pharmaceutical and medical device manufacturers bear in mind?

Imports:

• Importers in Egypt face difficulties in securing the foreign currency required to procure products from abroad.
• To ensure uninterrupted production, manufacturers are advised to secure multiple EDA-approved active pharmaceutical ingredient suppliers – typically up to three.

Exports: One of the main obstacles to exporting pharmaceuticals is Egypt's low domestic pricing, as many countries use the price in the country of origin as a benchmark for imported pharmaceuticals. To address this, many companies register a second, export-only brand under the same regulatory file, with a higher price. This practice is generally tolerated by the EDA.

12. Protecting and incentivising innovation

12.1 What regulatory exclusivities are available to pharmaceutical and medical device manufacturers (both innovators and generics)?

In Egypt, patent linkage is a legal requirement for anyone applying for marketing authorisation for innovative or generic pharmaceutical products. In the process of registering the pharmaceutical products, the applicant company must submit a declaration confirming its compliance with the Intellectual Property Rights Protection Law (82/2002) and its executive regulations.

In addition, when registering an innovative product protected by a patent in Egypt, the applicant company must provide a properly legalised authorisation letter from the company that owns the IP rights for that product confirming that the product under registration is the innovative product. Also, if a generic product is based on an active ingredient that is protected by a patent, the applicant company must provide an acknowledgement stating that:

• it will not sell the generic product until the relevant patent for the active ingredient expires; and
• it will bear all consequences of violating the patent laws.

Egypt is a member of several patent conventions, such as:

• the Patent Cooperation Treaty; and
• the Paris Convention.

Companies with innovative products protected by a patent in an overseas country can extend the patent protection to Egypt when filing for the patent in the original country.

12.2 How is the data of pharmaceutical and medical device manufacturers protected during clinical trials, the marketing authorisation process and beyond?

Under the Intellectual Property Rights Protection Law, undisclosed information is protected as long as the information:

• is confidential and not widely known in the relevant industry market;
• has commercial value due to its confidentiality; and
• is safeguarded by its custodian.

Accordingly, data submitted to the relevant authority for pharmaceutical or medical device registration and beyond is protected until it loses its confidentiality.

Further, the Clinical Trials Law requires the principal investigator to maintain the medical research documents at the research site and with the sponsor, if applicable, while taking measures to prevent their loss or damage.

Moreover, under the Data Protection Law (151/2020), all health or medical-related data constitutes sensitive personal data that requires the relevant explicit written consent of the data subject in case of data processing. This law is still to enter into force, since its executive regulations have not yet been issued.

It is important to distinguish between:

• the requirement for consent of a subject to participate in clinical trials; and
• the requirements for the lawful processing of personal data under the Data Protection Law.

12.3 What other incentives are available to encourage innovation in the pharmaceutical and medical device space?

The Pricing Decree favours innovator pharmaceuticals, allowing them to be sold at relatively higher prices than generic products. Generic products can enter the market only:

• after the innovator's extended patent has expired; or
• through a licence agreement.

Furthermore, the Investment Law (72/2017) provides incentives for healthcare investment, including opportunities in:

• antibiotic production;
• oncology drugs;
• cosmetic products;
• active pharmaceutical ingredients; and
• vaccines.

Under certain conditions, projects under this law can benefit from a 30% tax deduction on taxable profits.

13. Trends and predictions

13.1 How would you describe the current industry landscape and prevailing trends in your jurisdiction? Are any new developments anticipated in the next 12 months, including any proposed legislative reforms?

Egypt's pharmaceutical industry is experiencing significant growth, driven by a focus on localisation and technological advancement. Government support, including public health initiatives and infrastructure development, is playing a crucial role in driving this progress.

One key development is the establishment of Gypto Pharma City, which aims to become the largest pharmaceutical hub in the Middle East. This state-of-the-art facility will:

• enhance local production;
• reduce reliance on imports; and
• attract foreign investment.

Additionally, a telemedicine law is being drafted, with the aim of improving access to healthcare services.

These developments indicate a shift towards greater regulation and oversight of the pharmaceutical and digital healthcare sectors in Egypt. Further regulatory reforms are expected, particularly in relation to telemedicine and e-health platforms, shaping the future of healthcare delivery and pharmaceutical manufacturing in the country.

14. Tips and traps

14.1 What are your top tips for pharmaceutical and medical device manufacturers seeking to operate in your jurisdiction and what potential sticking points would you highlight

• Companies are strongly encouraged to register patents for innovative products in Egypt without delay, even if market entry is planned for a later stage. Early patent registration protects against the registration of generic versions before product launch. Only pharmaceuticals with patents registered in or extended to Egypt enjoy this legal protection.
• The pharmaceutical sector is heavily regulated in Egypt and strict compliance with the relevant laws and regulations is required.
• Pharmaceutical pricing in Egypt is compulsory, with regulated profit margins imposed on the different stakeholders in the supply chain. Adherence to these pricing rules is mandatory to avoid legal liability. However, pricing reviews may be allowed under specific exceptional circumstances outlined by law.
• The establishment of a scientific office is essential for any company that intends to promote its registered products. The Egyptian Drug Authority (EDA) requires that a scientific office handle the process for the approval of advertising and promotional content.
• Patient support programmes (PSPs) are not extensively regulated under Egyptian law. However, when launching financial PSPs, companies must adhere to a specific regulatory process.
• The online trading of pharmaceuticals remains unregulated in Egypt, presenting potential risks and challenges. However, the EDA plans to introduce explicit regulations to govern the online sale of pharmaceuticals in the near future. This move has been prompted by the significant disruption caused by online ordering, as the public increasingly turns to various digital platforms, such as applications, to access and purchase medications with ease.
• Egypt's pharmaceutical market is highly sensitive to competition considerations due to its legal framework, which mandates a layered supply chain consisting of a manufacturer, distributor and pharmacy, underpinned by compulsory pricing regulations. As a result, it is crucial for companies to conduct thorough competition assessments for any commercial arrangements that they plan to undertake, in order to:
• • ensure compliance with local competition laws; and
  • avoid potential legal and regulatory challenges.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.