Singapore: HSA Adopts ICH E6 (R3) GCP Guidelines (w.e.f. 1 January 2026)

The landscape of clinical research is constantly evolving, and with it, the standards that ensure trial integrity and participant safety must adapt. A significant development in this realm is the introduction of the ICH E6 (R3) Guideline for Good Clinical Practice (GCP), which the Health Sciences Authority (HSA) will implement in Singapore starting 1 January 2026.

Get to Know GCP

Good Clinical Practice (GCP) is an internationally recognized ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials. One of the key regulatory mechanisms supporting GCP compliance is the GCP inspection.

GCP Inspection is an official review of documents, trial sites, sponsor facilities, or contract research organizations (CROs) involved in a clinical trial.

GCP inspections may target the trials of therapeutic products and Class 2 cell, tissue, or gene therapy products (CTGTPs) under Clinical Trial Authorization (CTA) or Notification (CTN), and the trials of medicinal products requiring a Clinical Trial Certificate (CTC).

Objectives of GCP inspections include:

• Protecting the rights, safety, and well-being of trial participants

• Verifying the quality and credibility of trial data

• Ensuring compliance with protocols, SOPs, and applicable regulations

What is ICH E6 (R3) and Why It Matter?

The ICH E6 guideline provides a framework to ensure ethical conduct and scientific integrity in clinical trials. The newly updated E6 (R3) version reflects advances in clinical trial design, digital technologies, and operational strategies. It promotes a quality-by-design and risk-proportionate approach, meaning trial activities should be tailored based on their impact on participant safety and data integrity.

Principal Investigators (PIs) play a pivotal role in the conduct of clinical trials at the site level. They must understand the updated GCP principles in depth and ensure all team members are trained beyond their routine clinical competencies in line with their delegated duties.

What Stakeholders Need to Do Now?

To ensure a seamless transition by 2026, stakeholders involved in clinical trials should begin preparation today. Key steps include:

1. Review the ICH E6 (R3) Guideline

Understand both the Principles and Annex 1 to align operations with updated standards

2. Conduct a Gap Analysis

Identify discrepancies between current practices and the new guideline. Update SOPs and processes accordingly.

3. Implement Proportionate Training

Provide targeted training to staff based on their delegated responsibilities and document the completion for compliance purposes.

Future Vision

The implementation of ICH E6 (R3) by HSA marks a significant step forward in aligning clinical research with global best practices. By starting early and investing in system-wide understanding and training, clinical trial stakeholders cannot only meet the 2026 deadline but also elevate the quality and trustworthiness of their research in the process.

Source: Health Sciences Authority (HSA)