About Enforcement Branch
As the regulatory authority for health products (which include different types of products such as pharmaceuticals, traditional medicines and medical devices), HSA administers various legal requirements and controls in accordance with the laws regulating health products e.g. Health Products Act, Medicines Act, Poisons Act.
While HSA generally seeks to encourage the health products industry to comply with all prevailing requirements and controls on their own accord and, in cases of default, to take the relevant corrective measures voluntarily, it is sometimes necessary under certain circumstances for HSA to enforce the requirements and controls by force of law - such as when the contravention has a potentially serious impact on public health or when the offending party clearly operates outside the regulatory system. In such instances, the Enforcement Branch of HSA's Health Products Regulation Group is tasked with enforcing the requirements and controls in accordance with the health products laws.
The enforcement process encompasses a range of activities - some of these are overt, while others are less obvious.
Enforcement operations are the most visible of the activities undertaken by the Enforcement Branch. These include all the functions and activities in which HSA's enforcement officers formally exercise statutory powers of enforcement - from investigating illegal activities involving health products, to inspecting consignments of health products that enter Singapore through the various checkpoints (operated by the Immigration and Checkpoints Authority).
In the course of these operations, HSA's enforcement officers regularly conduct surprise inspections and raids on unlicensed premises dealing in health products, and seize stocks of non-compliant health products (whether adulterated, counterfeit, unregistered or substandard) that are potentially hazardous to human health. For cases involving more serious contraventions, the offenders are prosecuted in Court.
(Photo, Right) Illegal drugs and medicines seized in the course of investigations conducted by Enforcement Branch. Seized items are destined for destruction, and will be disposed of once the case is concluded.
Besides the enforcement operations, the Enforcement Branch conducts various surveillance activities to keep track of developments on the ground and monitor the quality of health products in the market. Samples of different types of health products are acquired (through a variety of means) from different parts of the supply chain, and sent for testing to check for compliance with the applicable standards and requirements. Most notably, there are on-going quality surveillance programmes for the groups of products that are registered with HSA, such as pharmaceutical drugs and Chinese proprietary medicines.
The Enforcement Branch includes an intelligence element that manages all its information assets, and analyses the available information to produce timely and accurate intelligence to support enforcement needs. This element is crucial to the enforcement process as much of enforcement activities are intelligence-led, and intelligence is essential to maximising the effectiveness of enforcement efforts.
In its fight against illegal activities involving health products, the Enforcement Branch works closely with other regulatory and law-enforcement agencies in Singapore (e.g. Police, Immigration and Checkpoints Authority, Singapore Customs), and also collaborates with enforcement counterparts in the health regulatory authorities of other countries.