Good Clinical Practice Inspections

Implementation of ICH E6 (R3) Guideline for Good Clinical Practice (GCP)

The Health Sciences Authority (HSA) implemented the Principles and Annex 1 of the ICH E6 (R3) Guideline for GCP in Singapore on 1 January 2026. Annex 2 of ICH E6 (R3) GCP Guideline will be implemented in Singapore with effect from 1 January 2027.

The ICH guideline for GCP is an international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials. Compliance with GCP ensures 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 revised ICH E6 (R3) guideline has been re-organised to include an overarching Principles document and 2 Annexes:

• The GCP principles promote a quality-by-design and risk-proportionate approach to clinical trial conduct;

• Annex 1 provides information on how the GCP principles may be appropriately applied to interventional clinical trials; and

• Annex 2 addresses additional GCP considerations for interventional clinical trials that incorporate decentralised elements, pragmatic elements and/or real-world data.

  • Decentralised elements involve trial activities conducted outside the investigator’s location, such as electronic consent, telemedicine, home visits, home delivery of trial medications, digital health technologies, and electronic clinical outcome assessments.

  • Pragmatic elements involve the integration of usual clinical practice into trial design and conduct.

  • Real-World Data (RWD) refers to data from sources outside of clinical trials, such as Electronic Health Records, registries, and claims databases.

To ensure a smooth transition to the ICH E6 (R3) Guideline for GCP, interested parties should:

1. thoroughly review the ICH E6 (R3) Guideline for GCP;

2. perform a gap analysis and implement necessary changes for alignment; and

3. adopt a proportionate approach to training on the ICH E6 (R3) Guideline for GCP and document the relevant training completed.

As the individual responsible for overall trial conduct at the investigator site, the Principal Investigator (PI) should be familiar with ICH E6 (R3) and ensure that all persons assisting in the trial receive training appropriate to their delegated activities and are adequately informed of the relevant aspects of the guideline. This proportionate approach to training applies equally to sponsors.

Refer to Presentations - ICH E6 (R3) Guideline for GCP for more information.