Medical sovereignty: Malaysia should not automatically accept US FDA approvals

Malaysia's National Pharmaceutical Regulatory Agency (NPRA) has been working hard towards achieving WHO’s stringent Listed Authority status, leveraging its status as a WHO Collaborating Centre for Regulatory Control of Pharmaceuticals to reach the highest global standards of regulatory practice for approving medical products.

Although Malaysia allows for expedited regulatory review for pharmaceutical products previously approved by leading regulatory authorities in the US, EU, Australia, Canada, Japan, Switzerland, the UK, and Asean, it has always protected its own supplemental due diligence review of safety, efficacy, and assured quality and its own right to inspect pharmaceutical facilities.