What does EU Regulation 536/2014 mean for you?

1st January, 1970

What does EU Regulation 536/2014 mean for you?

With the increase in costs and the time it takes to complete a clinical trial, a change was needed for the bio-pharma industry. In came the EU Regulation 536/2014 to replace the outdated 2001/20/EC directive. The regulation was proposed in 2012 to keep up with the economic development of clinical trials, safeguarding of individual rights, staying in line with requirements of medical research, and more. This policy will ensure a greater level of harmonisation of the rules for conducting clinical trials throughout the EU.

Candidate Protection during Clinical Trials

The new regulation will have new rules on the protection of participants and consent. Previously, it was difficult to obtain free and informed consent, but the 536/2014 will specifically regulate cases where this opportunity isn’t available. The clinical trial drug will now be used on the basis of scientific evidence and marketing authorisation, so the procedure can be monitored for additional burdens. No compensation or assurances are required as the insurance coverage of the doctor, the institution or the products liability insurance offers enough coverage. Patients will also have more say with their review in the final report dedicated to the public.

Online Portal and Cooperation of Member States

Previously, to conduct clinical trials in certain countries, applications needed to be approved by each individual member state. With the 536/2014, only one submission is necessary to the ethics committee and regulatory authority which will represent all of the EU countries. This is now easier through the introduction of an online portal where applications will be submitted. The European Medicines Agency (EMA) will manage this system, and they will be responsible for all recruitment and termination procedures. This differs to when sponsors are required to submit this type of information to each member state. 


With the 2001/20/EC regulation, individual EU states ran different application processes for clinical trials. This made it difficult for them to be approved in other areas as they could be considered unacceptable for the respective country. Now, there is a new application procedure for clinical trials which will be divided in 2 parts, science and ethics.   

·         Part 1 – Based on scientific documents, and assessed by all relevant member states together. Questions include hypothesis to be tested, clinical relevance, safety measures, risk/benefit and more in relation to the clinical trial product.

·         Part 2 – Based on ethical aspects and assessed separately by members of the respective member state. Questions require information about patient, informed consent, insurance and refunds for assurance toward the patient.

There will be plenty more where that came from at the 20th edition of the Clinical Trial Supply Europe conference! Hear from clinical supply professionals as they go in depth explaining the future regulatory landscape and more detailed guidelines on EU Regulation 536/2014. For more information, please visit http://www.arena-international.com/ctseurope/ or alternatively email us at: events@arena-international.com


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