Malaysia NPRA implement Guideline on Facilitated Registration Pathway: Abbreviated and Verification Review with the aim of increasing the efficiency of the NPRA in pharmaceutical product registration.
The following information has been updated on the Guideline on Facilitated Registration Pathway:
1. Expansion of the scope of products
– New drug products, generic medicines and biologic including cell and gene therapy products
(CGTPs).
2. Addition of more reference agencies/procedures
– EMA, US FDA, Health Canada, PMDA, Swissmedic, TGA, and UK MHRA.
– WHO CRP (SRA and PQ) and ASEAN Joint Assessment.
3. Revision of the timeline
– Abbreviated review: 90 working days
– Verification review: 30 working days
Updated guidance document of Guideline on Facilitated Registration Pathway can be found at the following link:
https://npra.gov.my/index.php/en/guideline-bio/1527156-guideline-for-facilitated-registration-pathway.html