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Revised Regulatory Framework for Clinical Trials


Revised Regulatory Framework for Clinical Trials

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.​

IMPORTANT NOTICE: [HSA Clinical Trials] 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. 

For more information, download a copy of the HPA regulations from https://sso.agc.gov.sg/SL/HPA2007-S332-2016

Correspondingly, the Clinical Trial Guidance “Consent Requirements for Clinical Trials Involving Collection of Human Tissue” had been updated (version 1 Oct 2021) and can be downloaded from HSA | Guidance documents for clinical trials.

Additional Reading_HSA CT Regulations (Consent Req for HT Collection)

 

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. 

For more information, download a copy of the Regulations from https://sso.agc.gov.sg/SL/HPA2007-S332-2016

For more information, download a copy of the guidance from https://www.moh.gov.sg/hpp/pharmacists/guidelines.

Health Products (Clinical Trials) Regulations 2016 (Version in force from 1 October 2021) – Allowing Qualified Pharmacist to Be Principal Investigators In Clinical Trials

Additional Reading Info_Reg Pharmacist as PI HSA CT Guidance FINAL

 

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 HSA_CT@hsa.gov.sg should you require any clarifications.


IMPORTANT NOTICE: [HSA Clinical Trials] 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 2021 and Health Products (Clinical Trials) Regulations 2021 can be found the Singapore Statues Online Website.


Click here for the zip file of a consolidation of the Regulations.

  • Health Products (Cell, Tissue and Gene Therapy) Regulations 2021
  • Health Products (Clinical Research Materials) Regulations 2021
  • Health Products (Clinical Trials) Regulations 2021

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 may be found on HSA website.


Please contact HSA (HSA_CT@hsa.gov.sg) should you require further clarifications to the above.


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.

 

IMPORTANT NOTICE: GUIDANCE ON ELECTRONIC CONSENT & CRM NOTIFICATION NON-COMPLINANCE FORM (16 Dec 20)

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).

Click here to download the HSA Clinical Trials Guidance – Electronic Consent.

A copy of the guidance is also available on the HSA website (https://www.hsa.gov.sg/clinical-trials/regulatory-guidance).

2. CRM Notification Non-Compliance Form via FormSG

The purpose of this form via FormSG (https://form.gov.sg/5f0fc43b9e6a4a0011f18fe0) is for suppliers to notify HSA about non-compliances to applicable CRM regulations relating to CRM notifications. Kindly refer to HSA website (https://www.hsa.gov.sg/clinical-trials/crm-notification) for more information.

Please contact HSA (HSA_CT@hsa.gov.sg) should you require further clarifications to the above.
Disclaimer: Readers are advised to refer to HSA website for the latest information related to Clinical Trials, regulations and HSA Guidance documents.

 

IMPORTANT NOTICE : HSA GUIDANCE ON THE CONDUCT OF CLINICAL TRIALS IN RELATION TO THE COVID-19 SITUATION (27 March 20)


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.

Click here to download the HSA CTB COVID-19 Guidance for Clinical Trials

A copy of the guidance is also available on the HSA website (https://www.hsa.gov.sg/clinical-trials/regulatory-guidance)

Please contact HSA (HSA_CT@hsa.gov.sg) should you require further clarifications.

 

 Information and Resources

 

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

HSA Websites on the Revised Regulatory Framework

 

 

HSA Regulatory Guidances
 

 

Legislation – Statutory Acts and Applicable Regulations
 

 

 


 


 

Last Update: 21 May 2018