Compulsory Pre-market Approval for Health Supplements
Ministry of HealthSpeakers
Summary
This question concerns whether the Ministry of Health will consider mandatory pre-market approval or licensing for health supplements, as raised by Mr Melvin Yong Yik Chye. Minister for Health Gan Kim Yong stated that the Health Sciences Authority applies a risk-based approach, exempting supplements from pre-market approval because they are lower risk than pharmaceutical drugs. He highlighted that such regulations could increase consumer costs and limit product choices, aligning with regulatory models in the United States and European Union. While dealers are responsible for ensuring safety and truthful claims, the Health Sciences Authority maintains a robust post-market surveillance system involving routine sampling and testing. This system allows the government to monitor adverse events and remove unsafe products from the market to protect public health effectively.
Transcript
17 Mr Melvin Yong Yik Chye asked the Minister for Health whether the Ministry will consider compulsory pre-market approval or licensing of health supplements before they can be imported and sold in Singapore.
Mr Gan Kim Yong: The Health Sciences Authority (HSA) applies a risk-based approach in the regulation of different categories of health products. Western pharmaceutical drugs are used mainly by healthcare practitioners in the treatment and prevention of diseases. They are regulated stringently as they are inherently more potent.
Health supplements, on the other hand, are intended for enhancing a person's health. They are not meant to prevent, treat or cure diseases, or alleviate the symptoms of diseases. They generally contain well-established ingredients, such as vitamins, minerals or substances derived from natural sources. As health supplements are generally of lower risk than western pharmaceutical drugs, they do not require approval by HSA before they can be sold locally. They can be purchased over the counter without medical supervision. Our regulatory approach for health supplements is similar to that adopted by the United States, the European Union countries and Japan.
We are mindful that introducing pre-market regulation for health supplements could result in companies passing on the regulatory cost to consumers or forgo introducing products into Singapore which has a small market size, thereby reducing consumer choice.
Nevertheless, importers, wholesale dealers, sellers and manufacturers of health supplements are responsible for ensuring the safety and quality of their products. They must ensure that their products do not contain harmful substances or potent active ingredients used in western pharmaceutical drugs. Dealers must also ensure that product claims are truthful and not misleading, and that product advertisements do not make claims for treatment or prevention of diseases.
HSA has in place a post-market surveillance system to monitor the safety of health products, including health supplements. Our healthcare professionals report adverse events to HSA. HSA also keeps a close watch on safety issues encountered in other countries. In addition, HSA routinely samples health supplements sold here and tests them. Should there be any quality or safety concerns detected, HSA will take the necessary actions, including working with the companies to remove the products from sale or informing the public to stop consuming these products.