SINGAPORE Law and Practice Contributed by: Tony Yeo and Benjamin Gaw, Drew & Napier LLC
1. Life Sciences Regulatory Framework 1.1 Legislation and Regulation The Health Products Act 2007 (HPA) is the main legis- lation governing pharmaceuticals (which are referred to as “therapeutic products”) and medical devices. Therapeutic products and medical devices are also regulated under the following legislation and regula- tions: • the Health Products (Advertisement of Specific Health Products) Regulations 2016; • the Health Products (Medical Devices) Regulations 2010; • the Health Products (Therapeutic Products) Regu- lations 2016; • the Health Products (Clinical Research Materials) Regulations 2016; • the Poisons Act 1938 and its subsidiary legislation; and • the Sale of Drugs Act 1914 and its subsidiary leg- islation. The Health Sciences Authority (HSA) – a statutory body under the Ministry of Health (MOH) – is the main regulatory body that administers, applies and enforc- es the aforementioned legislation and regulations. The HSA also publishes guidelines in its administration of the legislation and regulations. As a statutory body, the HSA has substantial independence and autonomy over its operations. Nevertheless, it generally operates in line with the policy directions set by the govern- ment. 1.2 Challenging Decisions of Regulatory Bodies An appeal can be made in respect of any of the fol- lowing decisions made by the HSA: • refusal to register a health product; • attachment of any condition to the registration of a health product; • decision to recategorise or reclassify a health product; • decision to suspend or cancel the registration of a health product; • refusal to issue or renew a licence or to grant any approval;
• attachment of any condition to a licence; and • decision to suspend or revoke a licence or to can- cel an approval. Any person aggrieved by these decisions can make an appeal in writing within the time specified in the deci- sion notice to the Minister of Health, whose decision is final. The Minister may choose to refer the appeal to an Appeal Advisory Committee before making a deci- sion and will have to take into consideration any report made to him or her by the Appeal Advisory Committee in making the decision. This challenge procedure is specific to health prod- ucts. 1.3 Categories of Pharmaceuticals and Medical Devices Therapeutic Products Therapeutic products in Singapore are classified as Prescription Only Medicines, Pharmacy Only Medi- cines and General Sale List Medicines. These catego- ries of therapeutic products are regulated differently on the basis of the types of marketing authorisation required. Medical Devices The appropriate product registration requirements and evaluation route depend on the risk classification of the medical device. Medical devices are classified into the following risk groups, based on guidance developed by the Global Harmonisation Task Force: • Class A – low risk (eg, wheelchairs and tongue- depressors); • Class B – low to moderate risk (eg, hypodermic needles and suction equipment); • Class C – moderate to high risk (eg, lung ventila- tors and bone-fixation plates); and • Class D – high risk (eg, heart valves and implant- able defibrillators). In vitro diagnostic (IVD) medical devices are separately classified on the basis of their risk levels, as follows:
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