Policy

 

At present, member states in the Association of Southeast Asian Nations (ASEAN) region have to register a medical product separately subject to different national regulations, which results in varied approval times. Regulatory harmonization is a process where the technical requirements to develop and market pharmaceutical products become more uniform across different regulatory authorities. Regulatory harmonization has many advantages, such as promoting efficiency to support accelerated access to medicines and treatments, reducing unnecessary duplication and authorization of pre-marketing regulatory dossier and fostering best practice and resource sharing between regulatory bodies.

While regulatory harmonization in the ASEAN region is an ideal yet to be achieved for vaccine development and its rollout, ensuring uniform regulatory process has potential disadvantages, such as the over-dependence of resources and decision making on larger regulatory bodies. Due to the differences in capabilities and healthcare priorities in the region, regulatory convergence, where requirements and processes become more aligned over time, may be a more realistic goal for the ASEAN region. There is  an opportunity to strengthen regulatory convergence for vaccines in the region by convening national regulatory bodies and other stakeholders in governments, academia and industry to collectively address common technical and benefit-risk issues, developing guidance and training for regulators and building platforms to promote rapid data sharing.

Achieving Vaccine Regulatory Convergence and Agility in ASEAN: The way forward