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The National Pharmaceutical Regulatory Agency (NPRA) is set to introduce key initiative aimed at strengthening the quality monitoring of registered vaccines in Malaysia. This aligns with the WHO Global Benchmarking Tool for National Medicine and Vaccine Regulatory Systems, ensuring that the country stays at the forefront of regulatory readiness for vaccine safety and efficacy.
Key Highlights of the Initiative
1. Analysis Protocol Assessment
Beginning in 2025, NPRA will implement a phased evaluation of analysis protocols for registered vaccines in Malaysia. This measure aims to verify the testing procedures outlined in these protocols and ensure they are robust and reproducible.
2. Transfer of Testing Procedures
By 2027, or when the NPRA vaccine laboratory is fully prepared, the transfer of testing procedures from manufacturers to NPRA laboratories will become required for product registration. This process includes:
Verification of testing methods to ensure reproducibility
Collaboration between NPRA, vaccine manufacturers, and Product Registration Holders (PRHs) to facilitate a seamless transfer
3. Phased Implementation Approach
The phased approach will prioritize:
Phase 1 (2025): Vaccines listed under Malaysia’s National Immunization Program (NIP) and new vaccines undergoing registration
Phase 2: Registered vaccines not included in the NIP
Responsibilities for Product Registration Holders (PRHs)
To ensure the success of this initiative, PRHs and vaccine manufacturers are expected to:
Submit up-to-date analysis protocols with workable testing procedures
Prepare for the transfer of testing procedures to NPRA laboratories for verification
Update analysis protocols in the QUEST system as necessary through variation processes
Collaborative Engagement
This initiative has been in the pipeline since the engagement session on 15 November 2024, where initial briefings were conducted with PRHs. The proactive collaboration between NPRA, PRHs, and vaccine manufacturers underscores Malaysia’s commitment to maintaining vaccine quality and safety.
Moving Forward
These measures are not just regulatory steps but a commitment to enhancing public trust in Malaysia’s vaccine systems. By fortifying the quality assurance processes, NPRA ensures readiness to address any issues related to vaccine quality, safety, and efficacy effectively.
Let us work together to build a safer, healthier Malaysia through innovation and regulatory excellence. For further inquiries, please email us at info@arqon.com
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