Overview of Regulatory and Ethics Approval for a Clinical Trial
The Health Sciences Authority (HSA) is Singapore’s primary regulatory body responsible for ensuring the safety, quality and efficacy of health products, including overseeing the conduct of clinical trials. They evaluate and approve clinical trial applications, ensuring they meet required standards.
It is important to note that HSA oversees the regulation of clinical trials involving therapeutic products, Class 2 cell, tissue and gene therapy products (CTGTP)s and medicinal products such as Chinese Proprietary Medicines and health supplements that are being studied for disease treatment or prevention. However, HSA does not regulate observational clinical trials, medical device clinical trials and Class 1 CTGTP trials.
There are 3 types of clinical trial application, namely, Clinical Trial Authorisation (CTA), Clinical Trial Notification (CTN) and Clinical Trial Certificate (CTC). The distinction between the applications can be found in the table below.
|
CTA |
CTN |
CTC |
|
|---|---|---|---|
|
When does it apply |
A trial investigating one or more locally unregistered therapeutic products or Class 2 CTGTPs, or unapproved use of a locally registered product. |
A trial of locally registered therapeutic products or Class 2 CTGTPs used in accordance with their local approved labels. |
A trial that investigates one or more medicinal products for the treatment or prevention of diseases in Singapore. |
|
Turnaround time |
30 working days, or 15 working days for Phase 1 trials solely to evaluate bioequivalence, bioavailability, food effect or drug-drug interactions. 60 working days for Class 2 CTGTP trials. |
5 working days. |
30 working days. |
While the above information provides an overview, HSA official website should always be referred to for detailed and up-to-date information.
Institutional Review Board (IRB)
In Singapore, IRBs oversee the ethical conduct of clinical trials, ensuring the rights, safety and well-being of trial participants. Prominent IRBs include the SingHealth Centralised Institutional Review Board (CIRB) and the Domain Specific Review Board (DSRB) by the National Healthcare Group (NHG). There are also IRBs within Institutes of Higher Learning like the National University of Singapore (NUS), Nanyang Technological University (NTU), research organizations like Agency for Science, Technology and Research (A*STAR) and private sector institutions.
Yes, on 22 May 2014, a Memorandum of Understanding (MOU) was signed between SingHealth and NHG to mutually recognise one another’s ethics review. From 1 October 2014, multi-centre studies involving both review boards only need approval from one, based on the study Principal Investigator (PI)’s affiliation. If the PI is from SingHealth, CIRB reviews the application, and if from NHG, DSRB does.