Under the auspices of the ASEAN Consultative Committee for Standards and Quality – Pharmaceutical Product Working Group (ACCSQ-PPWG), and with technical guidance from the World Health Organization (WHO), the ASEAN Joint Assessment Procedure was developed by the National Regulatory Authorities (NRAs) of ASEAN Member States (AMS) to facilitate the marketing authorization of therapeutic products considered as a priority and/or of important public health value in ASEAN, as well as to encourage regional collaboration and work-sharing among the NRAs.
The ASEAN Joint Assessment Procedure is a formal procedure in which the same application for marketing authorization is simultaneously submitted to all the participating NRAs. Assessment work is then carried out together by all the participating NRAs and a joint assessment report is prepared. At the end of the process, a final decision on the application is taken by the individual NRAs through their normal decision-making process based on the joint assessment report and, where applicable, nationally-relevant considerations.
A more detailed guidance to assist the Pharmaceutical Industry and other stakeholders are provided in the following materials:
- ASEAN Joint Assessment Procedure for Pharmaceutical Products – Information for applicants Revision 2(14 November 2022)
- List of Priority Products for Joint Assessment Activities Revision 2 (14 November 2022)
- Frequently Asked Questions (FAQs) on the ASEAN Joint Assessment Procedure Revision 2 (14 November 2022)
- ASEAN Joint Assessment Information Management System (JAIMS) demonstration video: https://youtu.be/IAwtK2iV-UQ
Last updated: 15 March 2023