
Navigating the pharmaceutical regulatory landscape in Malaysia can be complex, especially for overseas companies aiming to register and market their products. Below are five essential FAQs that provide clarity on the pharmaceutical products approval process in the country.
Q.1.) How can a foreign pharmaceutical manufacturer register and market its pharmaceutical products in Malaysia?
Foreign pharmaceutical manufacturers must appoint a local agent (Product Registration Holder), which is a company locally registered in Malaysia, to hold the registration certificate. This local agent (Product Registration Holder) will be responsible for all matters related to product registration with the Drug Control Authority (DCA) before the products can be marketed in the country.
Q.2.) Do pharmaceutical products need to be registered before being marketed in Malaysia?
Yes, all pharmaceutical products must be registered with the Drug Control Authority prior to being marketed in Malaysia. Registration ensures that the product meets the safety, efficacy, and quality standards set by the regulatory authority. The National Pharmaceutical Regulatory Agency (NPRA), acting as the secretariat to the DCA, facilitates this evaluation and registration process.
Q.3.) Are there specific guidelines for the advertising of medicines in Malaysia?
Yes, there are specific advertising regulations in Malaysia. Businesses must be registered with the Companies Commission of Malaysia, and only pharmaceutical products registered with the Drug Control Authority can be advertised and sold. This is regulated by the Medicines (Advertisement & Sale) Act 1956 and Medicine Advertisement Board Regulation 1976
Q.4.) What is the role of the National Pharmaceutical Regulatory Agency (NPRA) in Malaysia?
The National Pharmaceutical Regulatory Agency NPRA (serves as the secretariat for the Drug Control Authority (DCA)) plays a key role in ensuring the safety, effectiveness, and quality of pharmaceutical, traditional, and cosmetic products in Malaysia. It also oversees the registration of pharmaceutical products and the licensing of importers, manufacturers, and wholesalers.
Q.5.) Is there a national medicines policy in Malaysia?
Yes, Malaysia has a National Medicines Policy. This policy ensures that only safe, effective, and quality medicines that meet approved standards are registered and allowed for sale and use in the country. It represents a coordinated effort among stakeholders in the healthcare system to maintain sustainability amid rising healthcare costs.
Conclusion
Understanding the pharmaceutical products approval process in Malaysia is essential for any company aiming to enter the market. With mandatory product registration, strict advertising guidelines, and the oversight of regulatory bodies like the National Pharmaceutical Regulatory Agency (NPRA), pharmaceutical companies must be fully compliant to succeed.
If you're looking to streamline your pharmaceutical products registration and regulatory compliance in Malaysia, Freyr can help.
Contact Freyr today for expert support tailored to your regulatory needs.