New EU Regulation for Clinical Trials with Medicinal Products Applicable on January 31, 2022
New harmonized procedure will validate clinical research done in the Netherlands for the whole of the EU
A new European regulation for clinical trials with medicinal products will be applicable on January 31, 2022. The Clinical Trials Regulation (CTR, EU no 536/2014) aims to create an environment that is favorable to conducting trials in the European Union (EU), with the highest standards of safety for participants and increased transparency of trial information.
The regulation will require consistent rules for conducting clinical trials throughout the EU making it attractive to conduct research there. It aims to foster innovation and research, while helping avoid unnecessary duplication of trials or repetition of unsuccessful trials. This means, that a trial done in one EU country is valid for the whole of the EU.
The Netherlands is in high demand as a location for conducting trials by developers of medicines. With the new EU regulation, the Netherlands ensures it continues to be optimally suited for the execution of clinical trials.
Single system for submitting research for EU
To support the new regulation, there will be one single entry point for submitting clinical trial information, helping to increase transparency. This Clinical Trial Information System (CTIS) is developed by the European Medicine Agency (EMA). EMA will make information stored in CTIS publically available subject to transparency rules.
Dutch Life Sciences & Health sector prepares for new regulation
The Netherlands Life Sciences & Health sector is ensuring it is prepared for the implementation of the new EU regulation. Several involved parties are making the final preparations, including the Central Committee for Research on Human Subjects (CCMO), the accredited medical research ethics committees (MREC) and the Dutch Clinical Research Foundation (DCRF). They will be able to complete the assessments of clinical trials within the timelines set by the EU regulation.
Information about new procedures
The CCMO offers researchers the opportunity to practice with the new submission portal. It has also published information on its website about the new procedure for submission, assessment, conduct and end of trial (including trial results).
The new EU regulation has a transitional arrangement for ongoing trials – these can continue under the previous legislation up to three years and new clinical trials can also be submitted in the former manner in the first year.
Researchers planning to submit a clinical trial in the near future or who would like more information about the new regulation can contact the CCMO National Clinical Trial Office in the Netherlands: [email protected].
27 January 2022