Find out about the collaborations under the ASEAN Joint Assessment Procedure for Pharmaceutical Products
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:
Regulatory overview
Register your product
Apply for post-approval variation
Reclassify your product
Dealer's licensing and certification
Retain, cancel or transfer product registration
Risk management plan requirements
Report adverse events
Report or recall defective products
Retail pharmacy licensing
Clinical trials
Product consultation
Advertisements and promotions
CPP and SLS
International collaboration
Medicines quality and compliance monitoring
Listing of approvals and post-registration actions
Guidance documents
Fees and turnaround time
PRISM (Therapeutic products)
Infosearch