Singapore Proposes Pharmaceutical Regulatory Changes

Singapore’s Health Sciences Authority (HSA) is planning to transfer regulatory control of drug products, currently regulated under the Medicines Act and the Poisons Act, to the Health Products Act. The HSA believes that this will help update, clarify and streamline Singapore’s existing regulatory controls for pharmaceuticals.

Under the proposed change, drugs will be called “therapeutic products,” defined as “a health product that is intended for a therapeutic, preventive, palliative or diagnostic purpose.” This category includes chemical and biologic drugs.

During this regulatory move, the HSA will implement four sets of subsidiary legislation under the Health Products Act. This legislation will cover drug manufacture, registration, clinical trials, supply, import, advertising, adverse event reporting and enforcement measures. Some regulations will be updated in the process. The HSA has announced that it plans to implement these regulatory changes in the third quarter of 2015.