Snapshot

The Priority Pathway pathway has been developed by the National Pharmaceutical Regulatory Agency of Malaysia.

This pathway can be used where new product application (in the category of new drug products, biologics and generics)..

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

An application for Priority Review should be submitted via a formal letter to the Director of NPRA within one month after the payment has been confirmed. The approval of Priority Review is subjected to the decision of the Drug Evaluation Committee Meeting upon submission of complete product registration documentation and does not exempt applicant from any product registration requirements. TIMELINES: Full evaluation of new drug products and biologics = 120 working days (Starting from the date of approval of Priority Review). Generics (scheduled and non-scheduled poison) = 100 working days (Starting from the date of approval of Priority Review).