The New Clinical Trial Regulation & Its Benefits


 
 
 
 
 
 
 
 
The Clinical Trial Regulation will come into operation in 2018 and replace the existing EU Clinical Trial Directive (EC) No. 2001/20/EC. This regulation will change the way clinical trials are conducted in the European Union (EU) by harmonizing the assessment and supervision processes for clinical trials throughout the EU via an EU portal and database which will be maintained by the European Medicines Agency (EMA) in collaboration with the Member States and the European Commission. EMA will make information stored in the database publicly available subject to transparency rules.

The clinical trial application form and supporting dossier will include the public registration of the clinical trial and any subsequent updates. It will also apply to trials authorized under the previous legislation if they are still ongoing three years after the Regulation has come into operation.

Key Benefits

The regulation will harmonize the electronic submission and assessment processes for clinical trials conducted in multiple Member States, as well as improve collaboration, information-sharing and decision-making between and within Member States. Other benefits include, but are not limited to: increased transparency of information on clinical trials and the highest standards of safety being ensured for all participants in EU clinical trials.

Structure

There will be 3 different workspaces:

  • Sponsor workspace: will assist clinical trial sponsors in preparing and compiling data to submit to the database for assessment by Member States; respond to requests for information and view deadlines; manage users and user roles.
  • Authority workspace: will support the activities of Member States and the European Commission in overseeing clinical trials by viewing application dossiers; manage tasks related to the assessment of clinical trials; collaborate within and between Member States; record inspections of sites and clinical trials.
  • Public website: members of the public can access detailed information (in all official EU languages) on all clinical trials conducted in the EU, such as overview of clinical trial statistics and download data and reports.

Assuring a safer market

The new clinical trial regulation will increase the efficiency of all trials in Europe with the greatest benefit for those conducted in multiple Member States. It aims to foster innovation and research, while helping to avoid unnecessary duplication of clinical trials or repetition of unsuccessful trials.

If you wish to know more about the new clinical trial regulation or wish to conduct one in Europe, please do not hesitate to contact us. Obelis Expert Consultants, having nearly 30 years of experience with EU Regulations, will gladly answer any question you may have and will gladly assist you in safeguarding your products’ compliance.

Flavia Ursa

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