he area of the Gulf Cooperation Council (GCC) is regarded as an "emerging market" for pharmaceutical exports and bilateral trade. Learning this region's regulatory requirements can be beneficial for pharmaceutical exports. The Gulf countries ' regulations promote the importation of quality generic products, which facilitates a boost in the trade and economy. In GCC countries, the drug industry reaches USD 6 billion approximately. This demand is rapidly growing and is expected to reach around USD 10 billion by 2020. Given this market's rise, local manufacturing is unable to meet the growing demand, and GCC countries continue to import most (90%) of their drug needs from abroad. Therefore, there are substantial opportunities for growth and development of this sector in GCC Besides, expanding growth in this industry will help achieve the region's strategic objectives in terms of industrial diversification into knowledge-based sectors.
The emerging sector aims at achieving the following objectives:
- Establish a forum for the exchange of ideas and dialogue between pharmaceutical companies in the GCC
- Propose a multi-client study to address the needs of the region's pharmaceutical industry
- Identify the need for GCC producers to create a pharmaceutical trade association.
With Kuwait accelerating its plan for healthy growth as part of Kuwait's 2035 dream, the Ministry of Health (MoH) is also focusing on expanding their projects. Both the pharmaceutical and healthcare industries in Kuwait have been identified as high-priority sectors, with many initiatives under public-private partnerships (PPPs) are being carried out.
2. Kuwait Pharmaceauticals Market Overview
With the boost from the government's healthcare initiatives, the pharmaceuticals market in Kuwait is currently at a growing stage. Initially, the domestic manufacturing of medicines in the country was low due to the focus inclining towards the booming oil and gas industry coupled with limited diversification into various other sectors. It is pertinent to note that the pharmaceutical industry is closely monitored by the government, and the demand for branded and patented products has stretched the government's budget for the same. The growing trend of preventive healthcare such as the demand for pseudo pharmaceutical products like supplements and vitamins, smoking cessation aids, weight loss formulations, etc, have supported the expansion of healthcare awareness, thereby witnessing the inception of government initiatives for driving pharmaceuticals to build factories which are in line and in collaboration with the Public Authority for Industry.
3. The Regulation Process
Medicines in Kuwait are regulated on the basis of standards of quality, safety and efficacy, price control and patent protection. The nation has 40 years of regulatory framework experience and plays a leading role in the regulatory environment of the GCC.
The pharmaceutical sector of Kuwait entertains various multi-source products which are imported from multiple countries and regions. The regulatory framework set in place attempts to ensure the following objectives:
- The product has been licensed and sold for at least twelve months in countries with recognized and competent regulatory authorities
- That the product follows the desired quality standards, globally accepted, to ensure that the product is manufactured for its intended use
- That the product remains stable throughout the projected shelf life
- For local patients, the price of the product must be reasonable and affordable.
The regulation framework consists of different phases to ensure that the pharmaceuticals products that help ensure that the products are of the best quality to provide steady growth and development; the stages are as follows:
3.1 The Submission Phase
The review process begins with the local agent (or sponsor) sending the registration dossier together with a covering letter to the Kuwait Drug and Food Control Manager (KDFC) formally demanding the pharmaceutical material registration
3.2 The Evaluation Phase
In this phase, the reviewer will evaluate the Chemical and Manufacturing Control (CMC) data after entering the scientific review stage, focusing on the following data:
- Material descriptions and detailed analytical methods for finished products
- Total stability analyses of the expected consumer shelf life
- Specifications of raw materials and their procedures of analysis
3.3 The Authorization Phase
Upon completion of the full evaluation, the final approval decision is taken by the DRRS, which is officially endorsed by the authority's director.
4. The Data Required for Registration of Pharmaceutical Products
In accordance with Ministerial Decree 302/8, the Kuwait Food and Drug Authority (KuFDA) is the head regulatory agent to register pharmaceutical products.
In order to initiate the trade and supply of any pharmaceutical product, the product must be registered in order to ensure that proper regulation can take place, the various documents and requirements needed to register the product are listed below:
- Preview of the finished product
- Legalized certificate of free sale issued by health authorities to COO, showing the brand register & sell with the same name & composition
- Legalized price certificate issued by COO authority, including ex-factory price, COO wholesale price
- Storage conditions
- Name of developed countries where the commodity is licensed, the foreign company's license and the foreign company's business establishment.
- A leaflet containing all the details (English and Arabic) such as:
- Description: product name, strength, active substance, list of excipients, dosage, warning about certain excipients for example lactose
- Indication, use and clinical pharmacology
- Dosage and method of administration
- Warnings and Precautions
- Product supply origin and inactive components
- Specifications of raw materials
- Specifications of finished products and methods of quality control
- Stability data
- Accelerated studies: six months, three times the same batch, used for long-term research
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