Spring Intro 2023

24/03/2023

Regulation (EU 536/2014) and Transparency

• All information in the EU database will be publically accessible unless its confidentiality can be justified on the basis of:

o Protection of commercially confidential information o Protection of personal data o Protection of confidential communication between EU countries o Ensuring effective supervision of the conduct of clinical trials by EU countries

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Transparency for the EU database

• Rules prepared by EMA's board EMA / 228383/2015 • Three categories (product development phase) - ex. Protocol published with different delay after decision on review

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