December 17, 2019

EU commission publishes a new version of the draft Q&A on the application of the clinical trials regulation

In November 2019, the European Commission published a draft version of the answers to the numerous questions (“Q&A”) raised by stakeholders relating to the implementation of the rules laid down in Regulation (EU) No. 536/2014 on clinical trials.

The Q&A were grouped into different sections, each relating to a specific topic, such as the scope of the clinical trial regulation in the EU, clarifications on substantial modifications, withdrawals and regarding the submission of results of clinical trials, sponsor/legal representative and investigator.

The Q&A are available here: https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/regulation5362014_qa_en.pdf

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