Revised Regulatory Framework for Clinical Trials Updates

Revised Regulatory Framework for Clinical Trials Updates

** Disclaimer: Readers are advised to refer to Singapore Statues Online Website, HSA website for the latest information related to Clinical Trials, regulations and HSA Clinical Trial Regulatory Guidance. Please contact HSA at helpdesk@hsahelp.gov.sg for any enquires.

Updates on the amendments to the Health Products (Clinical Trials) Regulations and the Health Products (Clinical Research Materials) Regulations (1 October 2021)

1. Informed Consent Requirements for the Collection of Human Tissue from Trial Participants

To safeguard the rights, safety and well-being of trial participants, the Health Products (Clinical Trials) Regulations has been amended. Effective 1 Oct 2021, specific additional information must be provided to trial participants prior to obtaining consent for the collection of human tissue for the purposes of the clinical trial. 

2. Enabling Pharmacist to be Principal Investigators of Clinical Trials of Locally Registered Therapeutic Products

The Health Products (Clinical Trials) Regulations has also been amended to enable pharmacists to be principal investigators of clinical trials of locally registered therapeutic products, subject to certain safeguards and requirements. These safeguards and requirements are detailed in the “Guidance for Pharmacist Principal Investigator” issued by the Chief Pharmacist’s Office, MOH. The guidance can be downloaded from the MOH website. 

 3. Amendments to the Requirements for Clinical Research Material Containing Codeine Cough Preparations

MOH has worked with HSA to make amendments to the Health Products (Therapeutic) Regulations (“TP Regs”) to change the supply limits for sale and supply of codeine cough preparations. Consequential to the amendments to the TP Regs, the HSA Regulatory overview of clinical trials​ has been amended to:

  • Remove the codeine supply restrictions for clinical research materials, in view of the existing research governance frameworks in place to curb the abuse of codeine in the context of clinical research studies; and

  • Cover all dosage forms of codeine cough preparations, in the requirement for export approval for consignments of codeine-containing clinical research materials, to align with the requirements under the TP Regs.

Please contact HSA at helpdesk@hsahelp.gov.sg for any enquiries.

Updates on the implementation of the Cell, Tissue and Gene Therapy Products Framework (1 Mar 2021)

The Health Sciences Authority (HSA) has introduced a new category of health products to be regulated under the Health Products Act, namely, cell tissue and gene therapy products (CTGTP). The new controls take effect on 1 March 2021.

The new and amended regulations i.e. the Health Products (Cell, Tissue and Gene Therapy) Regulations 2021, Health Products (Clinical Research Materials) Regulations and Health Products (Clinical Trials) Regulations can be found at the Singapore Statues Online website as follows:

HSA had also updated their regulatory guidance. The following regulatory guidance, which include more substantial updates are:

  • Determination of whether a Clinical Trial requires Clinical Trial Authorisation (CTA), Clinical Trial Notification (CTN) or Clinical Trial Certificate (CTC)

  • Regulatory Requirements for New Applications and Subsequent Submissions

  • Clinical Research Materials

  • Labelling of Investigational and Auxiliary Products in Clinical Trials

Where relevant, HSA had also taken the opportunity to provide more information in the guidance to address common enquiries by Clinical Trial Stakeholders. All Clinical Trial Regulatory Guidance Documents are available at HSA Guidance Documents for Clinical Trials.

Please contact HSA at helpdesk@hsahelp.gov.sg for any enquiries.

Guidance on Electronic Consent & the CRM Notification Non-Compliance Form (16 Dec 2020)

1. Guidance on Electronic Consent

The purpose of this document is to provide guidance to sponsors and investigators on electronic consent (i.e. e-consent).

2. CRM Notification Non-Compliance Form

The purpose of this Form is for the notification of Clinical Research Materials (CRM) non-compliances to HSA.

Please contact HSA at helpdesk@hsahelp.gov.sg for any enquiries.

HSA Guidance on the conduct of Clinical Trials in relation to the Covid-19 Situation (27 March 2020)

The Health Science Authority (HSA) has released a guidance to provide general considerations to sponsors and investigators to ensure the safety of trial participants, compliance with the clinical trials regulations and ICH GCP (R2) Guidelines, and minimise risks to trial integrity, during the Covid-19 Outbreak.

Please contact HSA at helpdesk@hsahelp.gov.sg for any enquiries.

Information and Resources

Researchers are advised to refer to the following resources for more information:


** Disclaimer: Readers are advised to refer to Singapore Statues Online Website, HSA website for the latest information related to Clinical Trials, regulations and HSA Clinical Trial Regulatory Guidance. Please contact HSA at helpdesk@hsahelp.gov.sg for any enquires.

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