Dr. Ramli Bin Zainal
National Pharmaceutical Regulatory Agency (NPRA),
Ministry of Health, Malaysia
Vaccine approval process in Malaysia is regulated by the National Pharmaceutical Regulatory Agency (NPRA) which ensures the safety, effectiveness and availability of vaccines through its comprehensive regulatory review mechanisms.
Premarketing approval stage
Documentation requirements for product submission must adhere to the ASEAN Common Technical Dossier (ACTD) format. The evaluation of vaccine applications is done by the Biotechnology Product Registration Section within NPRA.
The evaluation process encompasses internal review on the quality, efficacy, and safety characteristics. Views and opinions from subject matter experts were also obtain for additional information as necessary. The submission must also contain a full description of manufacturing methods and evidence of compliance with cGMP requirement. The applicant is also required to submit the analytical methods and validation documents for evaluation by the Centre for Quality Control. The final evaluation report is then presented to the Drug Control Authority for consideration.
Post approval Stage
Lot-Release testing is a regulatory requirement that mandate all licensed vaccines undergo appropriate lot testing before release. The test may include those for bacterial and fungal sterility, general safety, purity, identity, suitability of constituent material, and potency. Depending on the product, additional testing may be required. In addition, constituent materials such as diluents and preservatives must meet standards for sterility.
Facility inspection after licensure is a continuous monitoring process to determine if licensed products are manufactured and tested as described in the license and in accordance with applicable regulations. Manufacturers that fail to meet product standards or do not comply with cGMP may have their licenses suspended or revoked, depending on the nature of the inspectional ﬁnding.
Post marketing surveillance is a vital component of vaccine-safety monitoring. Among the objectives of post marketing surveillance are to monitor increases in known reactions, to identify rare adverse reactions and to identify possible signals of adverse reactions. By law, it is a requirement to provide ongoing reports of the safety issues. The NPRA may require applicants to make necessary safety labelling changes and to comply with risk evaluation and mitigation strategies.
Vaccines are a valuable resource in the management of many infectious diseases. The NPRA ensures the safety, effectiveness, and availability of vaccines through its regulatory review mechanisms. NPRA provides regulatory oversight which includes laboratory testing and clinical evaluation. Stringent regulatory prerequisites must be achieved throughout development for a vaccine to be considered for licensure. After licensure, the NPRA continues to monitor vaccine safety through lot-release testing, inspections, and product surveillance.
The content is authorized by Dr. Ramli Bin Zainal on October 30, 2017.