Drug developers deeply concerned
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Drug developers deeply concerned

28.11.2013 - EU industry associations urge EU legislators: Don’t make the regulatory process too long, putting Europe’s competitiveness at risk.

Just before Christmas, the European Commission, European Parliament and the EU Council are expected to finalise the Clinical Trials Regulation. However, drug developers and manufacturers are deeply concerned. They believe that the  compromise could fail to meet the original goal of the Regulation which was to reverse decreasing numbers of clinical trials carried out in the bloc.

In a joint statement EuropaBio, the European Federation of Pharma Industry Associations (EFPIA), the Association of Clinical Research Organisations (ACRO), Cancer Research UK, and the Patients Network for Medical Research and Health (EGAN) have urged the legislators not to dilute the original aim of the regulation:  "It is imperative to build on Europe’s innovative edge – not just for competitive reasons, but because innovation is the tool needed to deliver new and improved medicines to patients,“ they stress.  "The longer the regulatory process takes to approve a clinical trial, or process regulatory procedures around it, the greater the cost of the trial. Higher costs can result in fewer trials being run, reducing our ability to understand treatments better. Towards this end, we strongly support the path set out by the Commission as well as the European Parliament in ensuring competitive timelines for these authorisations, and urges the Council to support this approach moving forward.“

The associations say it is essential to ensure that timelines are predictable and are in no case longer than the timelines already established in the current Directive. The proposal of the Commission initially intended to shorten the Clinical Trial Authorisation Timeline from 60 days (90 days for advanced therapy medicinal products such as gene and cell therapies) to 25 days (plus 5 extra days for ATMPs). However as there are member states where the timeline is significantly longer, industry fears that the Council will prolong the timeline. According to EuropaBio "everything going beyond 60 days would clearly be uncompetitive and send the wrong signal“. 

Short timelines at high quality level, however, are possible. In the UK, the initial assessment is performed within 30 days, according to the MHRA. Applications for Healthy Volunteer Trials and sponsor-determined Phase I trials in non-oncology patients will be assessed and processed within 30 days, with an average of 14 days or less.


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No liability assumed, Date: 08.10.2015