In December 2022, the European Commission published an updated version of the Q&A guidance on the Clinical Trials Regulation (“CTR”). This new version was issued shortly ahead of the 31 January 2023 deadline from which all new applications for the approval of clinical trials must be submitted in accordance with the CTR.
The most important amendment to the Q&A is the inclusion of a new Annex III.
The application dossier for the approval of a clinical trial in accordance with the CTR is composed of two parts. Part I of the application dossier relates to scientific aspects of clinical trials that are considered to be scientifically harmonized among EEA countries. Part II relates to country-specific, patient-level requirements, which may vary from one EEA country to another. The European Commission has developed standardized templates for documentation required for Part II of the application dossier. However, certain EEA countries have also developed their own national templates.
As a result, when operating in the EEA, sponsors may be confronted with divergent national requirements of individual EEA countries. The updated Q&A aims to provide sponsors with a consolidated list of national sources where sponsors can identify national requirements and any applicable templates in individual EEA countries. This information should assist sponsors in navigating the specific requirements of individual EEA countries and submitting high quality and appropriate documents as part of their application dossiers for the approval of clinical trials.
Annex III provides an overview table containing links to the websites of all EEA countries where sponsors can find information regarding national requirements of individual EEA countries. Annex III also includes the e-mail addresses of the national competent authorities of EEA countries to which enquiries may be submitted.