Singapore: New Regulatory Guideline for Medical Products Proposed

On June 15, 2005, Singapore’s Health Sciences Authority (HSA) announced a proposal for a new Health Products Act. While the proposed Act is only a draft (and currently subject to feedback from the public), the HSA hopes this legislation will eventually become the main regulatory guideline for all health products in Singapore, including pharmaceuticals, medical devices, traditional medicines and health supplements.

Presently, there are four laws governing medicines in Singapore: the Medicines Act, the Medicines Advertisement and Sale Act, the Poisons Act, and the Sales of Drugs Act. These laws cover product registration, manufacturing, importing, distribution, promotion and sales, and others, but also overlap in some areas; this overlap has caused confusion and complications for some medical companies entering the Singaporean pharmaceutical market.

The Health Products Act will initially function as a mechanism for consolidation, combining the above four acts into a single, comprehensive, and more generalized regulatory guideline. Specifically, the regulation will provide classification information for all health products in Singapore, and subsequent information on product registration, manufacturing, importing, advertising, and others. Its more general format should also allow for the regulation of medical devices in Singapore in the future.