Research with a medicinal product
From 31 January 2022 the new Clinical Trial Regulation (CTR) 536/2014 will apply to research with medicinal products in the European Union (EU). The CTR replaces the Clinical Trials Directive 2001/20/EC, which has been embedded in the WMO in the Netherlands.
Contrary to the Clinical Trials Directive, the CTR stipulates that the procedures for the submission, assessment and conduct of research with medicinal products are the same in the EU. A transitional period of three years applies:
- Year 1: You can choose whether to have a new application assessed according to the CTR or according to the WMO.
- Years 2 and 3: New applications must be assessed according to the CTR.
- From year 4: All ongoing research with medicinal products must comply with the requirements of the CTR.