EU Clinical Trial Regulation 2022 –Impact on Regulatory, Labeling & QP


A panel of Thermo Fisher Scientific experts discuss the implications of the new EU Clinical Trial Regulation for pharmaceutical companies and their research and commercial partners, things to watch out for, and the special case of Great Britain and Northern Ireland.

The conduct of clinical trials in the EU under existing legislation suffers from disharmonized interpretation and wide variation in execution across member states. This has led to excessive administrative and regulatory burden, costs and delays—and ultimately a significant drop in the number of trials conducted in the region. To remedy this situation, in 2014 the European Commission approved a new EU Clinical Trial Regulation intended to simplify clinical trials administration and create a more welcoming climate for pharmaceutical companies that operate in Europe. The regulation, which is legally binding and unifies regulatory, labeling, and Qualified Person (QP) requirements, is set to come into force early next year. In order to make the most of it and successfully complete clinical trials in the EU market, it is essential for sponsors to understand the changes and requirements it introduces.