SINGAPORE Law and Practice Contributed by: Tony Yeo and Benjamin Gaw, Drew & Napier LLC
• Class A (IVD) – low individual risk and low public health risk (eg, specimen receptacles); • Class B (IVD) – moderate individual risk and/or low public health risk (eg, vitamin B12 and pregnancy self-tests); • Class C (IVD) – high individual risk and/or moderate public health risk (eg, blood glucose self-tests and rubella tests); and • Class D (IVD) – high individual risk and high public health risk (eg, HIV blood-donor screening and HIV diagnostic kits). Clinical trials of therapeutic products are specifically regulated by the HSA under the Health Products (Clin- ical Trials) Regulations 2016. Clinical trials of medical devices are not regulated by the HSA. Clinical trials of medical devices that involve human biomedical research are required to comply with the requirements of the Human Bio- medical Research Act 2015, which is administered by the MOH. Clinical trials of medical devices that do not involve human biomedical research are currently unregulated in Singapore. 2.2 Securing Authorisation to Undertake a Clinical Trial Therapeutic Products In order to undertake a clinical trial of a therapeutic product, regulatory approval from the HSA and ethics approval from the relevant Institutional Review Board (IRB) must be obtained. 2. Clinical Trials 2.1 Regulation of Clinical Trials Applicants must first determine whether the clinical trial is subject to the requirements of a Clinical Tri- al Authorisation (CTA) or a Clinical Trial Notification (CTN). CTAs are required for higher-risk clinical trials involving therapeutic products that are unregistered in Singapore or uses of registered therapeutic prod- ucts that are unapproved. CTNs are required for low- risk clinical trials involving only registered therapeu- tic products used in accordance with their approved labels.
The clinical trial application, together with the relevant supporting documents, should be submitted by the sponsor to the HSA via its online platform, PRISM. The study may be initiated after the HSA accepts the notification of clinical trial or authorises the clinical trial. Medical Devices Authorisation is generally not required for clinical tri- als of medical devices. However, a notification must first be submitted to the Director of Medical Services before the commencement of any clinical trial of medi- cal devices involving human biomedical research. 2.3 Public Availability of the Conduct of a Clinical Trial Particulars of ongoing clinical trials are made publicly available online on the Clinical Trials Registry. All infor- mation in the Clinical Trials Register is maintained and updated by the local sponsors at least once every six months. The results of the trials are not made publicly available. 2.4 Use of Online Tools to Support Clinical Trials There are no restrictions for using online tools to sup- port clinical trials, as long as the use complies with the requirements and guidelines set out in the Inter- national Council for Harmonisation (ICH) E6 (R3) Good Clinical Practice Guidelines. 2.5 Use of Data From Clinical Trials Data from clinical trials is considered personal data under the Personal Data Protection Act 2012 (PDPA), Singapore’s primary data protection legislation. While there is no express categorisation of sensitive data in Singapore, the Personal Data Protection Commission (PDPC), which administers the PDPA, has taken the position in several enforcement decisions that medical data is more sensitive in nature and requires a higher standard of protection. Resulting data may be transferred to a third party or an affiliate if consent has been obtained from indi- viduals involved in the clinical trials. Data transfers are required to comply with the requirements of the PDPA.
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