What Is a Product Registration Holder (PRH) in Malaysia and Why You Cannot Hold Your Own MAL
A foreign manufacturer cannot hold its own Malaysian MAL. It must appoint a locally incorporated Product Registration Holder (PRH). Here…
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Regulatory Intelligence
Insights
Market analysis, regulatory updates, and strategic perspectives on pharmaceutical and medical device access in Southeast Asia.
MDA Establishment Licence Malaysia: What Foreign Manufacturers Need to Know Before Appointing a LAR
A foreign manufacturer cannot hold an MDA Establishment Licence directly in Malaysia. This briefing explains what the licence is, who…
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How Foreign Manufacturers Access Malaysia’s Public Sector Drug Market: APPL, Central Contract, and Local Purchase
Three routes into Malaysia's government drug market: APPL, Central Contract, Local Purchase. Why stable placement, not channel choice, drives price.
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Singapore to Malaysia Device Reliance: One Registration, Two Markets
Since 1 March 2026, a Singapore SMDR registration opens Malaysia's MDA Verification Route in about 30 working days. One dossier,…
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NPRA’s Facilitated Registration Pathway: FDA and EMA Drugs in 90 Days
Foreign manufacturers with a US FDA or EMA approval can now register in Malaysia far faster than the headline timeline…
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