ICH Guidelines Implementation

Background

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is an international non-profit association, with a mission to achieve greater harmonisation worldwide, ensuring that safe, effective, and high quality medicines are developed and registered in the most resource-efficient manner. Harmonisation is achieved through the development of ICH Guidelines and technical requirements for the development, approval, and safety monitoring of medicines. This process involves collaboration between regulatory and industry experts, as well as the implementation of these guidelines and technical requirements by its members.

Timeline for Application for Accession

In October 2023, the ICH has formally accepted the Pharmacy and Poisons Board of Hong Kong (“the Board”), Hong Kong, China as its observer. This step is crucial for advancing the implementation of ICH Guidelines in Hong Kong, with the ultimate goal of becoming an ICH regulatory member. The Government has set a target of submitting an application for ICH regulatory membership by the 2^nd quarter of 2027.

Prerequisites to Become an ICH Member

To meet the eligibility requirements for ICH regulatory membership, one of the requirements is implementation of ICH Tier 1 Guidelines, ICH Tier 1 Guidelines include:

• ICH Q1 (Stability)
• ICH E6 (Good Clinical Practice)
• ICH Q7 (Good Manufacturing Practice for Active Pharmaceutical Ingredients)

The Board has become a Pharmaceutical Inspection Co-operation Scheme (PIC/S) Participating Authority since 1 January 2016 and has adopted, inter alia, Part II of the PIC/S GMP Guide. The ICH Q7 Guideline is originally based on a PIC/S draft guideline on API and was adopted by PIC/S in 2001, then integrated as Part II of the PIC/S GMP Guide in 2007.

Establishment of the Task Force

To facilitate the implementation of ICH Guidelines, the Department of Health (DH) established the Task Force on Implementation of ICH Tier 1 and Preparation on Tier 2 Guidelines Implementation (the Task Force) in 2025. This Task Force includes representatives from the trade and related stakeholders and has been actively formulating implementation plans for ICH Tier 1 Guidelines. The primary objective of the Task Force is to advise the Government on gaps between the current local regulatory regime and the requirements of ICH Tier 1 Guidelines, and to formulate a timeline and implementation plans for both ICH Tier 1 and Tier 2* Guidelines.

Proposed Implementation Plans for ICH Q1 and E6 Guidelines

To meet the target of applying for ICH regulatory membership by 2^nd quarter 2027, the following implementation plans have been proposed by the Task Force:

1. Q4 2025 and onwards: Continuous engagement with relevant stakeholders.
2. Q1 2026: Formal implementation of ICH Q1 Guidelines.
3. Q2 2026: Enhancement of relevant online platforms and formal implementation of ICH E6 Guideline.
4. By Q4 2026: Imposition of new conditions to all newly issued Certificates for Clinical Trial (CCTs).

The implementation plan has been endorsed by the Board accordingly. The table below tabulates the implementation status of relevant ICH Guidelines. The pharmaceutical industry and relevant traders / stakeholder should be aware of the implementation of ICH Guidelines and ensure compliance with the guidelines in product development and application submissions. By adhering to these guidelines, companies and the industry at large can strengthen the safety, efficacy, and quality of their pharmaceutical products, facilitate regulatory approval processes, and promote greater harmonization across the global marketplace.

* Regulatory members are required to submit specific implementation plan for ICH Tier 2 Guidelines (including E2A,E2B,E2D,M1 and M4) with milestones and timeframes, within the five years after the approval of their memberships to ICH. The remaining ICH Guidelines (Tier 3 Guidelines) should be implemented in the near term and as soon as possible.