ARTICLE
17 January 2023

European Commission Publishes Updated Q&A On Clinical Trials Regulation

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Cooley LLP
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Clients partner with Cooley on transformative deals, complex IP and regulatory matters, and high-stakes litigation, where innovation meets the law. Cooley has nearly 1,400 lawyers across 18 offices in the United States, Asia and Europe, and a total workforce of more than 3,000.
In December 2022, the European Commission published an updated version of the Q&A guidance on the Clinical Trials Regulation.
European Union Food, Drugs, Healthcare, Life Sciences
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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 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 European Economic Area (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, but some EEA countries have 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 a consolidated list of national sources where sponsors can identify national requirements and any applicable templates in those countries. This information should assist sponsors in navigating the specific requirements of individual EEA countries, as well as submitting high-quality and appropriate documents as part of their application dossiers for the approval of clinical trials.

Annex III provides a table listing the websites of all EEA countries, where sponsors can find information regarding national requirements of each EEA country. It also lists the email addresses for those countries' national competent authorities to which sponsors may submit inquiries.

Cooley legal trainee Anastasia Vernikou also contributed to this alert.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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ARTICLE
17 January 2023

European Commission Publishes Updated Q&A On Clinical Trials Regulation

European Union Food, Drugs, Healthcare, Life Sciences
Contributor
Cooley LLP logo
Clients partner with Cooley on transformative deals, complex IP and regulatory matters, and high-stakes litigation, where innovation meets the law. Cooley has nearly 1,400 lawyers across 18 offices in the United States, Asia and Europe, and a total workforce of more than 3,000.
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