The Health Sciences Authority (HSA) of the Ministry of Health (MoH) is the agency that is responsible for the regulation of therapeutic products in Singapore. It is important to note that medical devices, health supplements, traditional medicines, Chinese proprietary medicines, and cosmetic products do not fall under the ‘therapeutic products’ category and have separate regulations of their own. Depending on the nature of the product, a Clinical Trial Authorization (CTA) may be required before clinical tests can be conducted. Therapeutic products must be registered with the HSA where different application forms exist for new drug application, generic drug application, biosimilar product application and submissions of drug master file and plasma master file. The product is assessed on its Good Distribution Practice and Good Manufacturing Practice requirements before a dealer’s license and certification can be issued. If this is not achieved, then the product will not be approved for distribution within the country. Similarly, a license and certification are also required for medical devices. Pharmacovigilance consulting firm may face challenges in navigating through the various requirements set by the HSA for obtaining marketing authorization for their products.

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