The Assembly of the International Council for Harmonisation (ICH) met in-person on the 15 - 16 November 2022, in Incheon, Republic of Korea in parallel of meetings of ten Working Groups, and preceded by meetings of the ICH Management Committee and the MedDRA Management Committee.
The meeting provided an important opportunity to advance work of ICH’s thirty-three Working Groups and key activities including training.
Progress on existing ICH Guidelines and harmonisation activities
ICH’s Working Groups have continued to progress their activities, with many groups making significant progress and with the adoption (Step 4) of a new guideline, ICH Q13 “Continuous Manufacturing of Drug Substances and Drug Products”. This new guideline describes scientific and regulatory considerations for the development, implementation, operation, and lifecycle management of continuous manufacturing (CM) specific to drug substances and drug products.
The Assembly also noted significant milestones reached by several Working Groups since the last ICH meeting:
- The guideline ICH E19 “A Selective Approach to Safety Data Collection in Specific Late-Stage Preapproval or Post-Approval Clinical Trials” was adopted (Step 4) in September 2022. This new guideline is intended to provide internationally harmonised guidance on the use of selective safety data collection - by tailoring the method of safety data collection, it may be possible to carry out clinical trials with greater efficiency by streamlining the approach to data collection with a controlled, risk-based approach. This may facilitate the conduct of large-scale efficacy and safety clinical trials with large numbers of participants and long-term follow-up;
- The Draft ICH Guideline M11 “Clinical electronic Structured Harmonised Protocol (CeSHarP), Technical Specification and Template” was agreed in September 2022 (Step 2). This new draft guideline is proposed to provide comprehensive clinical protocol organisation with standardised content, with 1) a Template which presents the format and structure of the protocol, including the table of contents, common headers, and contents; and 2) a Technical Specification which presents the conformance, cardinality, and other technical attributes that enable the interoperable electronic exchange of protocol content;
- The Draft ICH Guideline Q5A(R2) “Viral Safety Evaluation of Biotechnology Products” was agreed in September 2022 (Step 2). The revision retains key principles of the original guideline and provides additional recommendations on the established and complementary approaches to control the potential viral contamination of biotechnology products;
- An addendum to ICH S1B(R1) was adopted (Step 4) in August 2022, that was integrated with the original guideline and published as ICH S1B(R1) “Testing for Carcinogenicity of Pharmaceuticals”. The new addendum expands the evaluation process for assessing human carcinogenic risk of pharmaceuticals by introducing an additional approach that is not described in the original ICH S1B Guideline. Application of this integrative approach reduces the use of animals in accordance with the 3R (reduce/refine/replace) principles and shifts resources to focus on generating more scientific mechanism-based carcinogenicity assessments, while continuing to promote safe and ethical development of new pharmaceuticals.
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