SCRI HSA Public Webinar on Draft ICH E6 R3 Good Clinical Practice Guidelines
Good Clinical Practice (GCP) guidelines are essential for research, particularly for clinical trials. These guidelines serve as a beacon to steer researchers to uphold rigorous research protocol while safeguarding and protecting the welfare of research participants in a clinical trial or study.
The GCP guidelines are in place to maintain data integrity, protect against potential risks, and guarantee compliance with regulatory standards. When complied with, researchers will be able to maintain highest ethical standards and also enhance the credibility of their work.
These careful steps will in turn accelerate the advancement of new discoveries and scientific knowledge that will drive the development of safer or more effective medical therapeutics or interventions.
On 1 August 2023, the Health Sciences Authority (HSA) co-hosted a public webinar with SCRI Academy to provide an overview on the draft ICH E6 (R3) Good Clinical Practice (GCP) Guideline.
The event received an overwhelming response, attracting over 490 participants locally and overseas from the clinical research industry, public healthcare institutions and government agencies.
This session was conducted by Ms Sumitra Sachidanandan, Regulatory Consultant at the Innovation Office & Clinical Trials Branch of HSA.
The Health Sciences Authority (HSA) is the national regulatory authority of Singapore, which maintains regulatory oversight of clinical trials of therapeutic products, cell, tissue and gene therapy products and medicinal products (e.g. complementary health products), through evaluation of clinical trial applications, monitoring of clinical trial safety and conduct of GCP Inspections.
Introducing the ICH E6 Good Clinical Practice (GCP) guideline
The ICH* E6 Good Clinical Practice (GCP) guideline is an international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials that involve the participation of human participants. It aims to provide a unified standard for the ICH regions to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.
HSA has been an observer to the ICH platform since 2007 and was accepted as a Regulatory Member of the ICH in November 2017. HSA actively participates in various ICH Expert Working Groups, including the ICH E6 (R3) Expert Working Group.
Following the call for modernisation of clinical trials and subsequent renovation of the ICH E6 (R2) GCP guideline, the ICH E6 (R3) Expert Working Group has been working on revising the GCP guideline since Nov 2019.
The revised ICH E6 (R3) GCP guideline will facilitate innovation through novel clinical trial designs (including the use of decentralised elements and digital health technologies), and focuses on key concepts such as quality by design, and adopting a fit for purpose and risk proportionate approach.
What should we look out for in the ICH E6 (R3) GCP guideline
Ms Sumitra shared that the draft ICH E6 (R3) GCP guideline will comprise a principles document, Annex 1 (considerations for interventional clinical trials) and Annex 2 (additional considerations for interventional clinical trials).
She elaborated on the key changes to be incorporated into the principles document and Annex 1 during the webinar. The attendees noted that a new section on Data Governance for sponsors and investigators has been included, and substantial changes have been made to the GCP principles, investigator, sponsor, essential records, glossary and appendices sections of the revised guideline.
The draft ICH E6 (R3) GCP guideline is expected to be published in end 2024. Once published, HSA will inform its stakeholders on the implementation timelines for Singapore.
Why is this important
As the ICH E6 (R3) GCP guideline will be a major revamp from the ICH E6 (R2) GCP guideline, and it would be crucial for sponsors and investigators to be re-trained on the revised guideline and revise their Quality Management Systems in order to ensure compliance.
The principles document and Annex 1 of the draft ICH E6 (R3) GCP guideline are currently available for public consultation till 30 September 2023. The draft Annex 2 guideline will be shared at a later date.
The webinar concluded with a 75-min question and answer session, with over 80 questions addressed.
The attendees gave their virtual thumbs-up to express their appreciation towards Ms Sumitra and the HSA’s dedication towards international collaboration.
Materials available for download:
· Draft ICH E6 (R3) Good Clinical Practice guideline
We thank all participants for their enthusiasm and look forward to more collaborations with all ecosystem partners to enhance Singapore’s reputation as a choice destination to conduct high quality clinical trials.
Click here to find out more about the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)*.
Click here to view a recording of the webinar.
*International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use