The virtual meeting of the ICH Management Committee Meeting and the Assembly of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) took place in the week beginning 16 November 2020. This replaced the conference scheduled to be held in Athens (Greece), where the 30th anniversary ICH celebration was to have taken place. However, due to the current situation, it had to be cancelled.
Despite the current situation, the working groups were able to continue working on their Guidelines. Therefore, Version 1.1. of the User Guide of EDQM Terminologies for Dose Forms and Routes of Administration for Individual Case Safety Reports in the E2B(R3) were endorsed by the Assembly (Step 4).
It should be emphasised that the Assembly supports the Reflection Paper “Patient Focused Drug Development”, which is intended to ensure that the patient’s perspective is taken into account appropriately in the development of medicinal products.
The next virtual meeting of the ICH Assembly will be held on 2 June 2021. Instead of the celebration of the 30th anniversary, an article on the major milestones of the ICH will be developed with plans for release in 2021. More information can be found in the Public Statement.
On Thursday and Friday of the same week, representatives of the regulatory authorities met at the virtual meeting of the International Pharmaceutical Regulators Programme (IPRP), providing them with an opportunity to discuss the latest developments in the IPRP working groups.
The topic of “reliance” was once again the focus of this meeting. The WHO defines “reliance” as an act whereby a national regulatory authority in one jurisdiction may consider and give significant weight to evaluations performed by another authority or trusted institution or other relevant information in reaching its own decision. The WHO will publish the results of a survey on the use of “reliance”. The discussions will be continued at next year’s meeting.
The next IPRP meeting will take place on 7/8 June 2021 and will once again be held virtually. More information can be found in the Public Statement.