Implementation of ICH E6 (R3) Guideline for Good Clinical Practice (GCP)The ICH guideline for GCP is an international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials. Compliance with GCP provides assurance that the rights, safety and well-being of trial participants are protected, and clinical trial data are credible, facilitating mutual acceptance of the clinical data by regulatory authorities. The E6 (R3) guideline addresses GCP principles in the context of an evolving landscape of clinical trials, supporting innovations in clinical trial design, operational approaches, and technological advancements. It promotes a quality-by-design and risk-proportionate approach to clinical trial conduct.
The Health Sciences Authority (HSA) has adopted the Principles and Annex 1 of the ICH E6 (R3) Guideline for GCP, which will come into effect in Singapore on 1 Jan 2026.
To ensure a smooth transition to the ICH E6 (R3) Guideline for GCP, interested parties should: - thoroughly review the ICH E6 (R3) Guideline for GCP;
- perform a gap analysis and implement necessary changes to align with the new guideline; and
- adopt a proportionate approach to training on the ICH E6 (R3) Guideline for GCP and document the relevant training completed.
The Principal Investigator (PI) should be familiar with the ICH E6 (R3) Guideline for GCP, since the PI is overall responsible for trial conduct at the investigator site. The PI should ensure that persons or parties assisting in the clinical trial receive training appropriate to their delegated trial activities that go beyond their usual training and experience, and are adequately informed about the relevant aspects of the ICH E6 (R3) Guideline for GCP.
The proportionate approach to training on the ICH E6 (R3) Guideline for GCP also applies to sponsors.
Refer to the following for more information: |