Malaysia Pharmaceutical Registration and Approval

The Malaysian Ministry of Health is responsible for the country's healthcare system and the well-being of its citizens. The National Pharmaceutical Regulatory Agency is tasked with approving regulations, setting testing and quality control standards, as well as supervising the quality of pharmaceutical products. The Malaysian Drug Control Authority (DCA) mandates that all pharmaceutical products must meet safety, efficacy, and quality requirements. Additionally, the Malaysian Adverse Drug Reaction Advisory Committee performs pharmacovigilance on approved medications in the country, in accordance with the DCA. 

In Malaysia, pharmaceutical products are classified into four categories, namely new drug products, biologics, over the counter (OTC) generics, and generics. While some OTC products may undergo a shorter evaluation process, all other pharmaceuticals are required to undergo a complete evaluation through the DCA before being approved. 

To register a pharmaceutical product in Malaysia, the product must meet the safety, quality, and efficacy criteria established by the Drug Control Authority (DCA). Several factors need to be considered, such as the demand for the product, the risk of abuse of the product, dosage, the number of SIMILAR already registered products, and clinical effect.

The process of pharmaceutical registration in Malaysia is outlined below:  

  • Applicants must apply online and obtain membership registration on the QUEST3 platform 
  • The National Pharmaceutical Regulatory Agency (NPRA) conducts an initial review to ensure that the application dossier includes all necessary information 
  • Applicants must submit samples for laboratory analysis within 14 working days from the screening approval date; otherwise, the application will be rejected 
  • The NPRA may request more data or information from the applicant; the applicant needs to reply to the NPRA within 6 months of the date of receiving the NPRA’s request 
  • Once the technical evaluation has been completed and there has been communication with the applicant, the evaluator then carries out a review, and the final report is submitted to the Drug Control Authority (DCA) by the NRPA evaluation committee. 
  • The owner of the product registration will receive an official letter or email stating the regulatory decision 
  • The validity of a drug's marketing registration lasts for either five years or until the end of the validity period stated in the registration certificate, depending on which comes first.

  • To learn more about how PBM can help you register your drug products in Malaysia, please
    contact us.