< Back to all publications

Proposed Health Products Bill in Singapore

The Health Sciences Authority (HSA), a statutory board under the Ministry of Health, plans to table a Bill in Parliament to enact the proposed Health Products Act. This is to consolidate the controls for regulating medicines and health-related products in Proposed Health Products Bill in Singapore Singapore into one piece of legislation. Currently the controls are contained in various pieces of legislation, namely the Medicines Act, the Medicines (Advertisement and Sale) Act, the Poisons Act and the Sale of Drugs Act, along with their respective pieces of subsidiary legislation.The newest piece of existing legislation is the Medicines Act, which has been in place since 1975 while older ones date back to pre-independent Singapore. These Acts have encountered only minor changes over the years.

Although each these Acts focuses on different controls, there are areas in which their respective controls overlap, thereby making the regulatory regime confusing and unnecessarily complicated.

Therefore, the proposed Bill would bring the regulatory regime for medicines, which is currently separate, under a single piece of legislation with the other health related products. The legislation will cover various fields such as the supply, importation, distribution and manufacturing of medicines and health-related products, as well as the licensing, registration and advertising of the same. The new legislation will amend the Medicines (Advertisement and Sale) Act and rename it as the Medical Services (Advertisements) Act and it will also repeal the Poisons Act and the Sale of Drugs Act. The penalty provisions for contravening the respective controls, which in many cases are outdated and do not reflect the present economic realities will also be amended.

Therefore, under tougher penalties being proposed, persons who make or supply fake medicines and health products, which have been adulterated or tampered with, will face up to 3 years in jail and a $S 100, 000 fine. Offenders will face a $S 20, 000 fine under the new law for giving false information when applying for a license as compared with the current maximum fine of $S 5 000.

The proposed legislation is to become the principal vehicle for regulating all types of health products for human use, including medical devices, pharmaceuticals, traditional medicines and health supplements by amalgamating the existing controls for regulating medicines and health-related products into one omnibus Act.

It per se will not result in any immediate change in the Health Sciences Authority’s regulatory policies, as the proposed Act will essentially just consolidate the controls already in existence. The fundamental controls in the regulatory framework will be preserved and the legal provisions will be generalized so that they can potentially be applied to different types of health products.

コメントを残す

メールアドレスが公開されることはありません。 * が付いている欄は必須項目です