ICH reviews future ICH topics and its Organisation

Recommendation

13/14 December 2023
Berlin, Germany

Root Cause Analysis
A CAPA Workshop on Successful Failure Investigation

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.

ICH Reform

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.

ICH Q7

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

• V1.25 Question and Answer and Change Request document to the Electronic Common Technical Document (eCTD) has been updated to Step 4.
• The E2C(R2) IWG aims to reach Step 4 of the Questions and Answers (Q&As) to the Periodic Benefit-Risk Evaluation Report by the end of 2013.
• S10 EWG on "Photosafety Evaluation" reached Step 4.
• The Annex 6 "Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions" to the Q4B Guideline reached Step 4.

Source: ICH press release