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Regulation on clinical trials on medicinal products adopted

02 June 2014, Updated 03 June 2014

The European Commission's proposal for new European legislation on clinical trials of medicinal products was adopted in early 2014. The objective is to promote the number of clinical trials in the EU.

The objective of the new regulation is to promote the number of clinical trials in the EU, including trials with the same medicinal product in several EU countries. The regulation was adopted to harmonise the rules for authorisation as well as the overall conduct and monitoring of clinical trials throughout the EU.

The central principles from the applicable Directive 2001/20/EC on good clinical practice in connection with the conduct of clinical trials have been maintained. As a general principle, a clinical trial can only be conducted provided that the trial subject's rights, safety and welfare are protected and if data from the trial are reliable and robust. Moreover, a number of quality standards for the various trial phases and for the handling of data are also continued.

The regulation also comprises significant changes to the existing system for clinical trials. For example, a new model will be introduced for submission of applications as well as European and national collaboration between member states about authorisation of trials.

In future, clinical trial applications must be submitted to a common EU portal with an accompanying database so that any information about trials in the EU is accessible in one place. Where trials are to be conducted in several countries, the relevant countries' authorities will collaborate on the authorisation, and the national competent authority and ethics committees will work closely together. The European Commission and the European Medicines Agency provide technical support to the common assessment.

Other changes include provisions on clinical trials in emergency situations, risk-based requirements to the application material, shorter assessment times and simplified rules on safety reporting during the trial period.

Moreover, the regulation sets stricter requirements for public access to data related to clinical trials.

The Danish Health and Medicines Authority has participated in the negotiations on the proposal and is now represented in European and national working groups to prepare the coming into force of the regulation.

The regulation was recently published and is available on the Commission's website