EMA and EU Institute Regulations For Clinical Trials

The European Medicines Agency (EMA) announced in a press release that the European Union (EU) has published new Clinical Trial Regulations. The new rules mandate that the EMA must prepare an IT platform to help sponsors and experts carry out clinical trials and to ensure the public has access to the trials’ information. The EMA supports this effort as it will help Europe remain an attractive center for research. The IT platform will help member states, drug sponsors, experts, and the public carry out their roles related to safety and compliance, among other issues. The EMA said, “This will foster European competitiveness and innovative capacity, and facilitate swifter development of new medicines for patients. In addition to simplifying clinical trial approvals, the Regulation foresees transparency on the conduct of trials in the European Economic Area.”

EU Clinical Trial Regulations

The Clinical Trial Regulations were drafted by the Council of the European Union in Luxembourg. The rules are in the process of finalization set for June 2014. The new legislation will be enacted no earlier than mid-2016. The document states that the new rules arose from the need for uniformity in ethical issues, the need for high standards and safety, and to stop the trend of decreasing numbers of human trials conducted in the EU.

In the directive that the EMA must follow, the policy dictates that clinical trials need as many qualified patients as possible, therefore all EU member states should be included. Due to the time and cost of submitting applications to clinical trials, the EU intends to replace multiple submissions with a “single submission portal.”

EMA Role

The legislation keeps the authorization and oversight of trials with the member states and pharmaceutical companies. However, it authorizes the EMA to support drug sponsors with an IT platform to authorize trials, supervise them, report on safety, and inform the public of progress. The EMA says that until the new EU regulations take effect, it has established its own policy on proactive publication and access to clinical trial data.

The EMA conducted extensive public consultation on its draft policy, saying that viewpoints were diverse. Absent a legal framework, like the new EU rules, the EMA found it challenging to develop a policy to allow for competing views while allowing the Agency to move forward. The EMA will present its final policy in June 2014 and hopes that stakeholders utilize it as a transitional step before the Clinical Trial Regulations take effect.