13/14 December 2023
The results of the International Conference on Harmonisation (ICH) Steering Committee (SC) and its Expert Working Groups (EWGs) meeting in Osaka, Japan have been published.
The ICH SC furthered discussions on governance and increased engagement of regulators globally that had taken place in La Hulpe (Brussels) in June 2013. The SC agreed on organisational reform measures to foster international cooperation. In addition, the SC agreed to develop a 5-year plan for future ICH work and discussed potential new ICH topics to be further explored before the next meeting.
Here is an overview of the tasks:
Future ICH Topics
The ICH SC reviewed proposals for new topics provided by all parties and agreed on the development of concept papers for potential items such as providing further harmonisation on requirements for clinical trials. Future topics will be integrated in a 5-year plan.
The ICH SC continued its discussions on the reform of ICH. Principles for new rules of governance and membership were adopted to foster involvement in ICH activities.
The Q7 IWG on "Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients" met for the third time to develop a Q&A document to address current issues raised by the use of the Q7 Guideline.
Guidance and Documents
Source: ICH press release