ASEAN Joint Assessment Procedure for Pharmaceutical Products Information for applicants

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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.

 

 

 

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

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The Government of Malaysia and the National Pharmaceutical Regulatory Agency are not responsible for any loss or damage caused by the usage of any information obtained from this website.

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  • Last Modified: Monday 10 August 2020, 10:01:11.
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