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.
A transitional period of three years applies:
- Year 1: Between 31 January 2022 and 30 January 2023, when submitting a new research file, the submitter could opt for assessment according to CTR or assessment according to WMO.
- Years 2 and 3: From 31 January 2023, all new applications must be assessed according to CTR.
- From year 4: From 31 January 2025, all ongoing research with medicinal products must comply with the requirements of CTR.