1. Please briefly summarize your country's legislative framework for medicinal products (including biologicals), medical devices, food, and food supplements
According to Swiss nomenclature, the term therapeutic products covers medicinal products as well as medical devices.
- Medicinal products are products of chemical or biological origin which are intended or claimed to have a medicinal effect on the human organism, in particular in the diagnosis, prevention or treatment of diseases, injuries and disabilities. They include prescription as well as over-the-counter products.
- Medical devices are products, including instruments, apparatus, equipment, in vitro diagnostics, software, implants, reagents, materials and other goods or substances, that are intended or claimed to have a medical use and whose principal effect is not obtained with a medicinal product.
Therapeutic products in Switzerland are mainly governed by the Therapeutic Products Act (TPA) and the related ordinances, including the Medicinal Products Licensing Ordinance (MPLO), the Ordinance on Medicinal Products (OMP), the Ordinance on the Requirements of Marketing Authorization of Medicinal Products (OMAMP), the Ordinance on the Simplified Marketing Authorization Procedures, the Ordinance on Advertising of Medicinal Products (OMPA), the Ordinance on Medical Devices (MedDO), the Ordinance on In Vitro Diagnostic Medical Devices (IvDO; both the MedDO and the IvDO are largely modelled after the Regulation (EU) 2017/745 on medical devices [EU-MDR] and the Regulation (EU) 2017/746 on in vitro diagnostic medical devices [EU-IVDR])), the Ordinance on Integrity and Transparency in the Therapeutic Products Sector (TPITO). Switzerland's medical reimbursement of therapeutic products is governed by the Federal Health Insurance Act (HIA) and the related Ordinance (HIO). Depending on the circumstances, sector-specific regulations may apply, in particular in the fields of transplantation (Transplantation Act [TransPA] and related ordinances) and reproductive medicine (Reproductive Medicines Act and related ordinances). Certain raw materials for medicinal products are also subject to Swiss chemicals law. For clinical trials with therapeutic products see Question 7 below.
Foodstuffs (food and food supplements) are defined as all substances or products that are intended, or may reasonably be expected, to be consumed by humans in a processed, partly processed or unprocessed state.
Foodstuffs are mainly governed by the Federal Act on Foodstuffs and Utility Articles (FSA) and the related ordinances, including the Ordinance on Foodstuffs and Utility Articles (FSO), the Food Additives Ordinance (FAO), the Novel Foods Ordinance (NovFO), the Ordinance on Genetically Modified Foodstuffs, the Ordinance on Food of Plant Origin, Mushrooms and Table Salt (FPO-O), the Ordinance on the Addition of Vitamins, Minerals and Other Substances to Foods, the Ordinance on Foods for Persons with Special Nutritional Needs, the Ordinance on the Maximum Levels of Contamination, and the Ordinance on Information about Foods. Certain raw materials for foodstuffs may also be subject to the Swiss chemicals and biocides regulation.
2. With regards to medicinal products and medical devices, how is the regulatory process structured in your jurisdiction from R&D through market approval until post-marketing vigilance, and what rules does it follow? Please briefly describe.
At the R&D stage, the regulatory process may be distinct for research involving microorganisms and research involving humans. The research with microorganisms may involve activities involving genetically modified, alien, or pathogenic organisms that require containment in closed systems and fall under the Ordinance on Handling Organisms in Contained Systems (ContainO). Before starting any activity with organisms in a contained system, a detailed risk determination and a risk classification assessment must be carried out by a project leader to determine the safety level, the required safety measures and the notification and authorisation procedures. If research with microorganisms involves human biological samples, the HRA may also apply. Another important prerequisite for developing marketable products in the life sciences industries is research involving humans. In human research, there are two types of research projects. With regards to the regulatory framework for clinical trials see below in Question 7. The second type of research involving human subjects is called "other (non-clinical) human research project" and falls additionally under the Ordinance on Human Research except for Clinical Trials.
An authorisation to place medicinal products on the Swiss market requires an application (Article 11 TPA) and a detailed examination by the Swiss Agency for Therapeutic Products (Swissmedic), the national authorisation and supervisory authority for drugs and medical products in Switzerland. The applicant must hold a mandatory licence, which is issued by Swissmedic for an unlimited period of time and under the condition of possible periodic inspections (Articles 5, 18, 28 and 34 TPA). Depending on the characteristics and the application of the medicinal product in question, different authorization procedures may apply. However, the ordinary procedure applies for first authorizations of new active pharmaceutical ingredients (APIs) and major deviations (Article 9 para. 1, Articles 11 et seq. TPA; see Question 21 below for other authorization procedures for medicinal products). The period of validity for a marketing authorisation for medical products in Switzerland is five years. The authorisation is subject to subsequent renewal upon application (Article 16 para. 2, Article 16b para. 1 TPA). Swissmedic has the right to review the authorisation, adapt it to changed circumstances or revoke it at any time (Article 16c TPA). Medical devices do not require an authorisation by a public authority but instead a certificate of conformity prior to being placed on the Swiss market. The conformity assessment procedure is based on Articles 52 and 54 and Annexes IXXI of the EU-MDR (Articles 21 et seq. MedDO; Articles 17 et seq. IvDO). The certificate of conformity is valid for a maximum of five years and may be extended following a re-assessment (Article 26 MedDO). A designated body may suspend, revoke, or restrict the certificate, if there is a suspicion that the requirements are not fulfilled (Article 27 MedDO).
With regards to post-marketing vigilance see below in Question 4.
3. What is the regulatory process for food supplements, from first notification to the competent authorities until post-marketing vigilance in your country, and what regulations are applicable here? Please briefly describe.
Food supplements sold in Switzerland do not require an authorization from the cantonal or federal authorities. Nonetheless, in application of the principle of self-control, anyone who places food supplements on the market in Switzerland must ensure that the statutory requirements are complied with, in particular with respect to safety, hygiene and protection of consumers from deception (Articles 1, 7, 10, 15 and 26 FSA; Articles 8 et seq. and 45 et seq. FSO). Official inspection does not imply an exemption from the obligation to carry out selfsupervision (Article 26 FSA).
For certain foodstuffs, however, there are either positive lists (e.g., the exhaustive list of permissible vitamins and minerals in Annex 1 of the Food Additives Ordinance (FAO)), negative lists (e.g., the list of impermissible plants or parts or preparations thereof in Annex 1 of the Ordinance on Food of Plant Origin, Mushrooms and Table Salt (FPO-O)) or prior authorization requirements (e.g., for novel foods; Article 15 et seq. FAO and the Novel Foods Ordinance (NovFO)).
4. What are the ongoing obligations in your country after a marketing authorization for medicinal products has been obtained or a conformity assessment been carried out for medical devices?
Marketing authorisation applicants for medicinal products as well as medical device manufacturers must have a post-market surveillance system (pharmacovigilance and materiovigilance plans, respectively) in place (Article 11 para. 2 lit a no 5 TPA; Article 56 MedDO; Article 49 IvDO).
Marketing authorisation holders for medicinal products with an API or a biosimilar must periodically and automatically file periodic safety update reports (PSURs) with Swissmedic on the safety and risk-benefit ratio for four years after authorisation (Article 60 OMP). Depending on the classification of a medical device, its manufacturer has similar trend report, periodic summary report and PSUR obligations to the designated body involved in the conformity assessment (Articles 59 et seq. MedDO; Articles 52 et seq. IvDO).
As for incident notification requirements, manufacturers of medicinal products, distributors of ready-to-use medicinal products and health care professionals (HCPs) must notify Swissmedic of adverse events, adverse drug reactions and quality defects. Such notifications are voluntary for consumers, patients, their organisations, and interested third parties (Article 59 TPA). Similarly, anyone placing medical devices on the Swiss market as a manufacturer must report to Swissmedic all serious incidents that occur, as well as field safety corrective actions that are undertaken in Switzerland (Article 66 MedDO; Article 59 IvDO). In response, Swissmedic may take all administrative measures it considers necessary, including publishing recommendations and prohibiting the distribution and dispensing of therapeutic products, and ordering recalls (Article 66 TPA).
5. Which are the competent national authorities having the regulatory oversight over medicinal products, medical devices, food, and food supplements and what are their respective responsibilities?
In the sector of Swiss healthcare, the duties and responsibilities are divided among the federal, cantonal and municipal authorities. The Federal Office of Public Health (FOPH), as a part of the Federal Department of Home Affairs (FDHA), is responsible for public health in Switzerland. The cantonal authorities carry out enforcement tasks that are either assigned to them by the TPA or that are not expressly assigned to the federal government (Articles 69 et seq. and 82 et seq. TPA).
The authorization and supervision of therapeutic products lies within the responsibility of Swissmedic. Swissmedic, as a federal public law institution, is autonomous with respect to its organization and management.
The enforcement of food and food supplements regulation is decentralized and carried out by the cantons, unless the federal government, in particular the Federal Food Safety and Veterinary Office (FSVO), is responsible (Article 47 para. 1 and Articles 38 et seq. FSA).
6. Please briefly describe the procedure of challenging regulatory decisions (e.g., denial of marketing authorization) made by the competent regulatory authority in relation to medicinal products, medical devices, and food supplements.
Administrative decisions of regulatory bodies are usually issued in the form of a ruling. These rulings can be challenged in administrative procedures or administrative court proceedings. Depending on whether a federal or a cantonal regulatory body has issued the decision, the appropriate legal action must be taken. Decisions issued by a federal authority can be appealed to the Federal Administrative Court (FAC). The FAC's decision may be subject to further appeal to the Federal Supreme Court (FSC). Regulatory bodies can also issue administrative and criminal sanctions in which criminal procedure rules may apply.
7. Please briefly describe the legal framework and the relevant regulatory procedure (e.g., application process, requirements, approval, denial) that applies in your jurisdiction to clinical trials for medicinal products and medical devices.
The key Acts regulating clinical trials in Switzerland are the TPA, the HRA, the Human Research Ordinance (HRO), the Clinical Trials Ordinance (ClinO) and the Ordinance on Clinical Trials with Medical Devices (ClinO-MD). To conduct clinical trials with therapeutic products a previous authorisation from Swissmedic (Article 54 para. 1 TPA) and the competent ethics committee (Articles 24 et seq. ClinO and Articles 9 et seq. ClinO-MD) is required. For clinical trials regarding medicinal products, Swissmedic examines whether the Good Manufacturing Practice (GMP) and safety requirements are met (Article 54 para. 4 lit a TPA). If a clinical trial with medical devices is to be conducted, the assessment includes the conformity of the products with the safety requirements (Article 54 para. 4 lit b, Article 45 paras 1 and 3 TPA).
The conduct of a clinical trial must be in line with the rules of good clinical practice. Regarding medicinal products, these rules are defined in the ICH Guideline on Good Clinical Practice of 9 November 2016 and the WMA Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects (Article 5 para. 1 ClinO; Article 3 ClinO-MD). In the context of medical devices, the applicable rules on good clinical practice were incorporated into Swiss legislation by way of reference to Article 72 and Annex XV Chapters I and III of the EU-MDR as well as in EN ISO 14155.
The application to the ethics committee in the canton, in whose territory the study is conducted, must be submitted by the investigator (Articles 24 et seq. ClinO; Articles 10 et seq. ClinO-MD). The responsible committee will then issue a decision and inform Swissmedic in case an authorisation by Swissmedic is necessary. The application to Swissmedic must be submitted by the sponsor and Swissmedic will issue a decision.
For appeals against Swissmedic rulings, see above 6.
8. Is there a public database for clinical trials in your country, and what are the rules for publication?
Authorized clinical trials must be recorded in a public registry (Article 56 para. 1 HRA).
Medicinal Products
Sponsors of clinical trials with medicinal products must register the data defined in Annex 5 number 1 ClinO in either a primary register recognized by the World Health Organization (WHO) or the registry of the US National Library of Medicine (Article 64 para. 1 ClinO). Furthermore, the data must be registered in the supplementary Swiss federal (from March 2025: cantonal) database (Article 64 para. 2 ClinO). This provision is implemented through the cross-cantonal application submission platform known as Business Administration System for Ethics Committees (BASEC). In principle, the relevant data must be registered before the clinical trial is conducted (Article 65 para. 1 ClinO; Article 64 para. 4 revClinO, applicable from 1 March 2025).
Clinical trials that are being conducted in Switzerland are published in the Swiss National Clinical Trials Portal (SNCTP, Article 67 ClinO). The data originates from (i) the cross-cantonal application submission platform BASEC and (ii) the international study database ICTRP (WHO database comprising 17 worldwide primary registers). The data listed in Annex 5 number 2.1 to 2.14 revClinO will be made automatically accessible to the public at the latest within six months from the grant date of the trial authorization (Article 64 para. 5 revClinO), including a brief description of the clinical trial, the site(s) where the clinical trial is conducted, the criteria for the participation in the clinical trial, the disease category and the health condition investigated, as well as an indication of whether the clinical trial includes rare diseases.
Clinical trials authorized by an ethics committee are also published on the Registry of All Projects in Switzerland (RAPS) of swissethics, the umbrella organization of the cantonal ethic committees.
Sponsors of clinical trials must in principle register a summary of the results of the clinical trial in the respective trial registry (Article 64 para. 1 ClinO, Article 65a para. 1 revClinO), as well as a lay summary in the cantonal database within a year from completion or discontinuation of the trial (Article 65a para. 2 revClinO). Further, the marketing authorization holder of a medicinal product for human use containing a new active substance must publish the results of clinical trials conducted for its development within three months of the marketing authorization being granted, in the form of a report. However, if the licensing authority of a country with comparable medicinal product supervision has already made this report on the results of clinical trials publicly accessible, the marketing authorization holder may also refer to it (Article 71 OMP).
Medical Devices
Sponsors of clinical trials with medical devices are subject to analogous registration obligations (Article 41 ClinO-MD).
Public access to the results of clinical trials with medical devices must be ensured by the sponsor by publication in one of the registries listed in Article 64 para. 1 ClinO (Article 42 ClinO-MD).
9. Please briefly summarize the rules that must be observed in your jurisdiction when using data from clinical trials?
Health data is classified as personal data which is subject to special protection. The HRA governs the further use and disclosure of health data falling within its scope (Article 32 et seq. and 41 et seq. HRA). Generally, the disclosure of health data is permissible both within an organization and to third parties, depending on the nature of the data (genetic or non-genetic health-related personal data), its intended use (research or other purposes), the level of individual identification (coded, uncoded, or anonymized), and the extent of informed consent.
Under the HRA and its implementing provisions (Article 43 HRA; Article 5 HRO), individuals storing biological material or health-related personal data for research purposes must implement appropriate technical and organizational measures to prevent unauthorized use and adhere to specified operational and professional requirements.
Since 2016, the Declaration of Taipei on Ethical Considerations regarding Health Databases and Biobanks has complemented the Declaration of Helsinki.
10. Are there any trends and/or legislative proposals in your country on digitizing the process of conducting clinical trials (e.g., digitalization of the application process, decentralization of clinical trials)?
Swiss law already contains possibilities for integrating new technologies, which are especially relevant in the context of decentralized trials. However, determining the permissibility of decentralized clinical trials and hybrid decentralized clinical trials within the existing Swiss legal framework necessitates an evaluation and case-by-case assessment of their feasibility.
For example, using electronic informed consent is currently allowed in principle, but a handwritten signature is still required, unless the trial participant can provide a qualified electronic signature that meets the legal requirements of the Federal law on electronic signatures.
11. What are your country's legal requirements for the authorization of manufacturing plants for medicinal products, medical devices, food, and food supplements? Please briefly describe.
Medicinal Products
According to Article 5 para. 1 lit a TPA, the manufacture of medicinal products in Switzerland is subject to a mandatory license by Swissmedic. The license is issued if the necessary technical and operational conditions have been fulfilled and an appropriate system of quality assurance exists (Article 6 TPA; Article 3 et seq. MPLO). The license is issued for an indefinite period, whereby Swissmedic performs periodic inspections and may revoke licenses if the requirements are no longer met.
Medicinal Devices
In Switzerland, manufacturers of medical devices are not obliged to meet licensing requirements. However, if a manufacturer is not domiciled in Switzerland, their devices may only be placed on the market if the manufacturer has appointed an authorized representative in Switzerland. The authorized representative is responsible for the formal and safety-related aspects and is registered with Swissmedic (Articles 51 and 55 MedDO; Articles 44 and 48 IvDO; Article 11 EU-MDR/ EU-IVDR).
Food Supplements
Manufacturers of food supplements generally do not require a license. However, anyone who handles foodstuffs (i.e. anyone who manufactures, imports, exports, processes, treats, stores, transports, labels, advertises, distributes or sells foodstuffs) must report their activities to the competent cantonal authority (Article 11 para. 2 FSA; Article 20 FSO). Important changes in the business that could have an impact on food safety and the closure of the business must also be reported.
12. Please briefly describe the typical process of distributing medicinal products, medical devices, and food supplements in your country, encompassing, if applicable, the wholesale distribution of products.
Medicinal Products
The distribution of medicinal products typically involves wholesalers who purchase the medicinal products directly from manufacturers or importers. These wholesalers then distribute the products to pharmacies, hospitals, and other healthcare facilities. Any person engaged in the wholesale trade of medicinal products must have a license (Article 28 para. 1 TPA). The license is issued following an inspection by Swissmedic, if the necessary technical and operational conditions are fulfilled and an appropriate system of quality assurance exists (Article 28 para. 2 and 4 TPA; Article 11 et seq. MPLO). Furthermore, a license by Swissmedic is mandatory for the professional import of ready-to-use medicinal products intended for distribution or dispensing (Article 18 para. 1 lit a TPA).
Swissmedic categorizes medicinal products into four dispensing categories. These categories determine who is authorized to dispense, prescribe and use the medicinal product (Articles 24 et seq. TPA):
- category A – medicinal products that may be dispensed on a one-time basis on a physician's prescription (Article 41 OMP);
- category B – medicinal products that require a prescription and can be obtained several times, whereby medicinal products on list B+ can also be dispensed without a prescription (Article 42 OMP);
- category D – medicinal products that may be dispensed without a prescription, but after specialist advice (Article 43 OMP); and
- category E – medicinal products that may be dispensed without a prescription and without specialist advice (Article 44 OMP).
Any person dispensing medicinal products must have a cantonal license (Article 30 para. 1 TPA). Mail-order trade in medicinal products is prohibited in principle (Article 27 para. 1 TPA). However, in the cases specified in Article 27 para. 2 TPA, a cantonal permit may be issued for this purpose.
Medicinal Devices
Medicinal devices are typically distributed by the Swiss manufacturer or their wholesalers, or from importers. Where the manufacturer of a device is not domiciled in Switzerland, the device may only be placed on the market if the manufacturer designates an authorized representative domiciled in Switzerland by means of a written mandate (Article 51 para. 1 MedDO; Article 44 para. 1 IvDO). The manufacturers/wholesalers/importers supply the devices to healthcare facilities such as hospitals, clinics, and specialized medical equipment suppliers. Neither the wholesale nor the dispensing of medical devices require a license. However, manufacturers or their authorized representatives and importers must register with Swissmedic within three months of placing a device on the market for the first time (Article 55 MedDO; Article 48 IvDO). Medical Devices are supplied in accordance with their intended purpose and the information provided by the manufacturer (Article 68 MedDO; Article 61 para. 1 IvDO). Special provisions apply to the supply of certain in vitro diagnostic medical devices (Article 61 para. 2 and 3 IvDO).
Food Supplements
Food supplements are typically distributed through importers/wholesalers, who purchase them from manufacturers and supply them to retailers such as pharmacies, health food stores, supermarkets, and online platforms. The wholesale or distribution of food supplements is generally not subject to authorization. However, anyone who handles foodstuffs (i.e. anyone who manufactures, imports, exports, processes, treats, stores, transports, labels, advertises, distributes or sells foodstuffs) must report their activities to the competent cantonal enforcement authority (Article 11 para. 2 FSA; Article 20 FSO). Important changes in the business that could have an impact on food safety, as well as the closure of the business must also be reported.
13. Please briefly describe the pricing and reimbursement rules, if any, for medicinal products, medical devices, and food supplements in your jurisdiction?
Medicinal Products
According to Swiss law, the prices of medicinal products are regulated only with respect to reimbursement by the mandatory health insurance. For medicinal products not covered by said insurance, manufacturers, wholesalers, and retailers generally have pricing freedom. Regulations governing price determination are primarily outlined in the Health Insurance Act (HIA), the Health Insurance Ordinance (HIO), and the Ordinance on Benefits under Mandatory Health Insurance (OBHI).
Ready-to-use medicinal products qualify for reimbursement upon being listed on the Specialties List (SL). Medicinal products compounded in pharmacies are eligible for reimbursement if their active pharmaceutical ingredients (API) are listed in the List of Medicines with Tariff (LMT). The SL specifies both the ex-factory price and the public price, which represents the maximum amount (inclusive of VAT) insurers must reimburse in ambulatory settings. Health care service providers are prohibited from charging higher prices for medicinal products (so-called tariff protection, Article 44 HIA).
The FOPH determines the inclusion of a medicinal product on the Specialties List (SL) following consultation with the Federal Drugs Commission (EAK), except for certain cases such as generics, new galenic forms, or alternative package sizes of already listed medicinal products (Article 31 OBHI). An expedited procedure is available for products for which Swissmedic has approved an accelerated marketing authorization procedure (Article 31a OBHI). Inclusion on the SL is contingent upon meeting criteria of efficacy, suitability, and cost-effectiveness (Article 32 para. 1 HIA). Prices undergo review every three years (Article 65d HIO), with additional assessments occurring upon patent expiration and for newly authorized indications (Articles 65e et seq. HIO).
Price determination for medicinal products listed in the SL by the FOPH is based on two main criteria: (i) a therapeutic cross comparison, which evaluates the efficacy of the medicinal product compared to others used for the same indication (Article 65bbis HIO); and (ii) an international price comparison with the prices of the same product in certain other European countries (cf. Article 65bquater HIO; Articles 34abis-34c OBHI).
Generally, reimbursement is contingent upon the use of listed medicinal products for approved indications as authorized by Swissmedic and within approved quantities. Off-label uses can be reimbursed on a caseby-case basis according to the conditions outlined in Articles 71a-d HIO.
Medicinal Devices
The List of Items and Tools (LIT) defines the categories of devices eligible for reimbursement under the mandatory health insurance (Article 52 para. 1 lit a number 3 HIA). Unlike the SL, the LIT does not establish ex-factory and public prices but solely sets the maximum reimbursement amount. The tariff protection stipulated in Article 44 HIA does not apply to medicinal devices. Therefore, higher prices may be charged, with the patient (or a facultative private insurance) paying the difference. Specific regulations govern the process for seeking inclusion on the LIT (cf. Articles 21 et seq. OBHI). The FDHA decides on the listing following consultation with the Federal Commission for Analyses, Instruments, and Tools (FCAIT). The criteria of efficacy, suitability, and cost-effectiveness equally apply to medical devices (Article 32 HIA).
Food Supplements
In Switzerland, the pricing for food supplements is not regulated (apart from general limitations based on competition law).
Reimbursement for food supplements under compulsory health insurance is not provided.
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Originally published by Legal 500 Country Comparative Guides
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