23/12/2025
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23/12/2025
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KUWAIT CITY, Dec 23: As part of wide-ranging reforms to modernize Kuwait’s pharmaceutical and health regulatory system, Minister of Health Dr. Ahmed Al-Awadhi has issued four major ministerial decisions aimed at improving oversight, protecting public health, and ensuring the safety and quality of medicines and medical products in the market.
Together, these decisions create a modern regulatory system that governs how imported medical products are released and sold, how human medicines are registered and evaluated, and how cosmetic products are controlled. The measures are aligned with international best practices and are designed to raise safety and quality standards across the health sector.
The Ministry of Health explained that these decisions respond to the rapid growth of the pharmaceutical and medical industries. As the market expands, there is a growing need for clear, flexible, and accurate regulations that ensure products are safe, speed up procedures without weakening scientific checks, and increase public confidence in the Ministry’s registration and monitoring systems.
The new regulations also aim to unify existing rules, speed up registration and approval processes, and expand the use of digital systems. These steps are expected to improve the availability of medicines, support national drug security, strengthen the business environment, and ensure that consumers have access to safe and effective products.
First Decision: Regulating the Release and Sale of Imported Medical Products
The first decision gives exclusive authority to the Drug and Medical Products Registration and Control Administration to approve the release and sale of medicines and medical products. It sets clear rules for importing all regulated products, including human and veterinary medicines, herbal and plant-based medicines, health products, cosmetics, medical devices, medical supplies, and laboratory equipment. These measures are intended to ensure product safety from the point of entry into the country until they reach the market.
Second Decision: Regulating the Registration and Distribution of Medicines
Under the second decision, all medicines consumed by human beings must be officially registered before they can be sold. The decision introduces electronic verification of certificates whenever possible, removing the need for paper-based authentication and helping to speed up procedures. It also establishes eight different registration pathways, allowing greater flexibility depending on the type of medicine and the level of evaluation required.
Third Decision: Framework for Registering Human Medicines
The third decision sets out a clear and comprehensive framework for how human medicines are registered and evaluated. It defines the required procedures and conditions and establishes specific timeframes for evaluating applications under each registration pathway. This system improves transparency, makes decisions more predictable, and helps authorities work more efficiently.
Fourth Decision: Regulating the Registration of Cosmetic Products
The fourth decision introduces strict rules for registering cosmetic products intended for sale. It clearly defines registration requirements and sets the validity of registration certificates at five years. The authority is also empowered to suspend or cancel registrations in cases of proven violations by the product, the marketing company, or the manufacturer. These measures aim to protect consumers and ensure proper market control.
Taken together, these four decisions reflect a modern regulatory vision that combines strict oversight with simpler procedures. They mark a new phase in pharmaceutical governance in Kuwait, strengthen public health protection, boost confidence in products available in the market, and support the country’s ongoing digital and legislative transformation.
