The Clinical Trials Branch of the Health Sciences Authority (HSA) has regulatory oversight of clinical trials of therapeutic products* (i.e. pharmaceutical products - chemical and biologic drugs) and medicinal products (e.g. cell, tissue and gene therapy products, complementary health products) conducted in Singapore, through evaluation of clinical trial applications, monitoring of clinical trial safety and conduct of GCP Inspections. HSA also regulates the import and supply of clinical research materials for clinical research in Singapore.
Regulation of Clinical Trials
HSA adopts a risk-based approach in the regulations of clinical trials of therapeutic products. Such clinical trials are regulated under the Health Products Act and its subsidiary legislation, the Health Products (Clinical Trials) Regulations, and require either Clinical Trial Authorisation (CTA) or acceptance of Clinical Trial Notification (CTN) prior to initiation of the clinical trial.
Clinical trials of medicinal products are regulated under the Medicines Act and its subsidiary legislation, the Medicines (Clinical Trials) Regulations. Such clinical trials must have been granted a Clinical Trial Certificate (CTC) prior to initiation of the clinical trial.
All clinical trials must be conducted in compliance with the protocol, applicable clinical trial regulations, ICH E6 Good Clinical Practice (GCP) Guidelines and Standard Operating Procedures (SOPs).
Figure 1 and Figure 2 summarise the regulatory road maps for conducting clinical trials of therapeutic products and medicinal products respectively.
Figure 1: Regulatory Road Map for Conducting Clinical Trials of Therapeutic Products
Figure 2: Regulatory Road Map for Conducting Clinical Trials of Medicinal Products
Regulation of Clinical Research Materials
The import and supply of therapeutic products, medicinal products and medical devices for clinical research in Singapore are regulated under the Health Products (Therapeutic Products as Clinical Research Materials) Regulations, the Medicines (Medicinal Products as Clinical Research Materials) Regulations and the Health Products (Medical Devices) Regulations respectively.
Under these regulations, notification to HSA (“CRM Notification”) is required prior to import of overseas-manufactured CRM, or prior to supply of locally-manufactured CRM by the local manufacturer. In addition, local manufacturers, importers, suppliers of CRM and clinical trial sponsors are required to comply with duties and obligations under the regulations.
For enquiries on the regulation of clinical trials and clinical research materials, please click here to submit an enquiry.
For more information on the regulatory framework for clinical trials and clinical research materials, please click here.
|*With effect from 1 November 2016, pharmaceutical products are regulated as “therapeutic products” under the Health Products Act.
For more information on the TP Port-over Exercise and its implementation, please click here.
Frequently Used Links
Introduction to Clinical Trials
A general introductory guide on clinical trials
Guidances on regulatory processes, application submissions, conduct of clinical trials and clinical research materials
Target Processing Timelines
Processing timelines for clinical trial applications and amendments
List of FAQs on regulatory requirements, conduct of clinical trials and clinical research materials
Submit and manage clinical trial applications for clinical trials and clinical research materials
Clinical Trials Register
A publicly accessible register containing up-to-date information on ongoing clinical trials
Communications and updates to industry on clinical trials regulatory processes