Recent Meetings of the ICH and the IPRP

2 febbraio 2021 – In mid-November, the virtual meeting of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) took place. 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. At the same time, 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. Here, the topic of ‘reliance’ was the focus of this meeting, i.e. 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’.

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