From 16 to 20 November 2019, more than 450 participants attended the second biannual Assembly meeting of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) in Singapore, where they continued the work of harmonising Guidelines for human medicinal products. Swissmedic has been a Standing Regulatory Member of the ICH’s Management Committee and a Member of the ICH Assembly since 2015. The ICH Assembly currently comprises 16 Members and 32 Observers.
Expert meeting adopts new Guidelines on quality and medicinal product safety
The ICH Assembly elected the Brazilian therapeutic products regulatory agency Agência Nacional de Vigilância Sanitária (ANVISA) to the ICH Management Committee. Alongside the ICH Management Committee and Assembly meetings, experts from fourteen Working Groups met to commence or continue the process of drawing up Guidelines.
Particularly noteworthy was the adoption by the ICH Assembly of the results (Step 4 of the ICH process) of the ICH Q12, ICH E9(R1) and ICH M9 ICH Q12 Working Groups:
- ICH Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management
- ICH E9(R1) Guideline Addendum to Defining the Appropriate Estimand for a Clinical Trial/Sensitivity Analyses (revised version)
- ICH M9 Guideline Biopharmaceutics Classification System-based Biowaivers (new Guideline).
In the next stage, the regulatory authorities will implement these Guidelines.
The following Working Groups will commence work on a new ICH Guideline:
- ICH M13: Bioequivalence for Immediate-Release Solid Oral Dosage Forms
- ICH Q3E Guideline Impurity: Assessment and Control of Extractables and Leachables for Pharmaceuticals and Biologics.
The concept paper for the ICH Q9 Guideline on Quality Risk Management was approved, but the establishment of the Working Group is being deferred due to ongoing quality-related projects.
The Assembly was also informed that as part of the process of revising the Good Clinical Practices Guidelines, a public stakeholder meeting on the revision of the E8(R1) Guideline on General Considerations for Clinical Trials was held at the US Food and Drug Administration (FDA) on 31 October 2019. The aim was to involve interest groups from outside the ICH, such as patient organisations, in the discussions. In view of the positive feedback, the ICH Assembly discussed the possibility of incorporating these and similar activities into the process of drafting or revising other Guidelines.
The next ICH Meeting will take place in Vancouver, Canada, from 23 to 27 May 2020. The ICH will be celebrating its 30th anniversary next year. To mark the occasion, a special conference will take place immediately before the November 2020 ICH meeting in Athens (Greece).
Dr Gabriela Zenhäusern