ASEAN Joint Assessment Procedure for Pharmaceutical Products Information for applicants

Star InactiveStar InactiveStar InactiveStar InactiveStar Inactive

Joint assessment is a formal procedure in which the same application is simultaneously submitted to all participating ASEAN National Medicines Regulatory Authorities (NRAs).


Assessment work is then carried out together by all participating NRAs and a joint assessment report is prepared. At the end of the process, the final decision on the application is then taken, within established time lines, by each individual NRA through their normal decision-making process based on the joint assessment report and, where applicable, nationally-relevant considerations.