(3 April 2014 - Brussels): The global market for clinical trials is becoming increasingly competitive and Europe runs the risk of losing its status as an attractive environment for clinical trials research in the face of strengthening competition. The European Federation of Pharmaceutical Industries and Associations (EFPIA) thus welcomes the decision reached by the European Parliament in yesterday's plenary vote towards the adoption of the new Clinical Trials Regulation. EFPIA believes the new legislative framework will help foster a more harmonised approach to clinical trials in the EU, with a single submission and overall streamlined assessment process. EFPIA also welcomes the legislation’s approach to transparency, which respects the need to protect personal patient data and commercially confidential information.
While EFPIA sees the vote as a positive step forward in improving the European framework surrounding clinical trials, it believes that some of the initial objectives of the Regulation’s revision have been only partially achieved. The revision of the Clinical Trials Regulation aimed to improve efficiency of Clinical Trials Regulation process and, in turn, boost EU competitiveness as a clinical research hub, encouraging more efficient patient access to innovative medicines in the EU. It is critical that the Commission and EMA interpret the Clinical Trial Regulation in a manner that respects patient privacy, the integrity of regulatory decision-making, and incentives for companies to make long-term investments in biomedical research.