Recently, the National Pharmaceutical Regulatory Agency (NPRA) of Malaysia and the Japanese Ministry of Health, Labor and Welfare (MHLW) as well as the Pharmaceuticals and Medical Devices Agency (PMDA) have reached a significant consensus on the cooperation between these two countries in pharmaceutical regulation on a bilateral conference. As a result, Malaysia has officially designated Japan as a country for simplified drug review to accelerate the review of approved drugs in Malaysia.
From November 16, 2023, Malaysia will adopt the review reports issued by Japan's PMDA in its drug registration to simplify the review of various drugs including new drugs, generic drug, and products for cell and gene therapy. It is no doubt that 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.
The MHLW and the PMDA stated that they will deepen the pharmaceutical coordination and cooperation in Asia. The cooperation between Japan and Malaysia can not only strengthen their relationship but also improve their working efficiency.
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