ASEAN Joint Assessment Procedure for Pharmaceutical Products

Find out about the collaborations under the ASEAN Joint Assessment Procedure for Pharmaceutical Products

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The National Medicines Regulatory Authorities (NRA) of ASEAN Member States have developed a new procedure for marketing authorizations: the ASEAN Joint Assessment Procedure.

This is a formal procedure in which the same marketing authorization application is simultaneously submitted to all participating 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 taken by each individual NRA through their normal decision-making process based on the joint report and, where applicable, nationally-relevant considerations.

More information can be found below: