Snapshot

The Malaysia-Japan Cooperation on Simplifying Drug Review Procedure pathway has been developed by the of Malaysia.

This pathway can be used where Various drugs including new drugs, generic drug, and products for cell and gene therapy. .

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

When relevant, the agency relies on prior decisions from Japan

This new policy will shorten the drug review period from 245 working days to 90 working days, thus promoting the circulation of Japanese drugs to the Malaysian market.