Risk & Reward Index

Note: Scores out of 100; higher score = lower risk. Source: Fitch Solutions’ Innovative Pharmaceuticals Risk/Reward Index

Key foreign players

• Astrazenca
• GSK
• Merck & Co.
• Novartis
• Pfizer
• Sanofi
• Takeda

Strength

• Progressive government policy aimed at attracting international investment
• Improving local manufacturing standards
• Commitment to biotech development
• Sizeable and growing generic drugs market
• Manufacture of halal medicines improving access to other global Islamic markets
• New regulations for halal drug market

Challenges

• Low per capita pharmaceutical expenditure and foreign direct investment
• Law Patent Law remains conspicuously below international standards
• Strict government drug pricing policy heavily biased towards local drug producers
• Market reliant on imports, particularly at the hi-tech end of the scale, placing pressure on government finances

Regulations

• The Drug Control Agency (DCA), under Malaysia’s Ministry of Health (MOH), oversees drug registration
• In Malaysia, many high-end drug products are imported. Robust government spending on healthcare and attractive government tax incentives for foreign drug companies operating in the country lead to increased growth and opportunities for prospective foreign pharmaceutical companies
• Applications can be submitted to the DCA online via the Quest 2 system. There are four categories and generics. Although certain types of OTC products are eligible for an abridged evaluation, all other pharmaceutical products must undergo an entire evaluation via the DCA prior to approval. The estimated timeline for abridged evaluations is around 180 days; full evaluations can extend up to a year or more. Registrations are valid for 5 years and can be renewed.