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

This pathway can be used where Priority review may be granted for new product application (in the category of New Drug Products, Biologics and Generics) which fulfils either one of the following conditions; a) Product which is intended for: (i) Unmet medical needs (e.g. medicines for rare diseases, new vaccines, etc.) with no treatment options locally available, (ii) Life-saving such as for treatment/prevention of serious medical conditions (e.g. anticancer, antiretroviral, etc.) with no treatment options locally available, (iii) Treatment/prevention in pandemic/endemic situations, for the interest of public health, (iv) Emergency supply/crucial for treatment purpose according to the current needs in the country, (v) Supply to the Ministry of Health Malaysia under circumstances where alternative product with the same active ingredient is unavailable, b) Product which involves a change in the formulation due to the decision/instruction by the Drug Control Authority (DCA), for the purpose of formulation improvement with appropriate scientific justification(s), c) New application for products that have been registered with the same active ingredient for which the registration has been cancelled/withdrawn due to issues other than safety issues. Priority review will be considered based on individual/case to case basis and involves product that is crucial for treatment purpose. d) Product which is the first *generic/biosimilar product, or the first locally manufactured generic/biosimilar product. *No generic/biosimilar product has been registered by DCA at point of consideration on granting Priority Review. *The priority review status granted based on condition c) shall be cancelled during the duration of product application evaluation, in the event that a same/similar first generic/biosimilar product or first locally manufactured generic/biosimilar product has been approved for registration..

An application for Priority Review should be submitted via a formal letter addressed to the Director of NPRA once the screening has been approved. New Drug Products: 120 working days. Biologics: 120 working days. Generics (Scheduled Poison): 100 working days. Generics (Non-Scheduled Poison): 100 working days. *Days are counted starting from the date of approval of Priority Review.