How clinical trial legislation may put patients and trial results at risk

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The EFPIA view

A better regulation? Watch our video to find out why some elements may put patients and trial results at risk

20.10.14

The EU clinical trial legislation had previously been identified as a key piece of legislation to be improved. Following extensive debate, the new Clinical Trial Regulation was adopted in May 2014 and EFPIA strongly welcomed its content.

Last week, 14th Oct, the High Level Group on Administrative Burden, led by Edmund Stoiber, presented the results from their work on better regulation. However, certain technical provisions were introduced into Annex VI of the Regulation (covering labelling of medicines in clinical trials), which are inconsistent with the aims of the Stoiber Group:

Retest or Expiry Date Labelling in Clinical Trials

Updated labelling requirements that increase the likelihood of errors, risking patient safety and data integrity.
Further restriction of innovative IT solutions, which may put the EU at a competitive disadvantage.

The Regulation allows Annex VI to be updated. EFPIA is calling on the European Commission and the Parliament, as well as the Member States, to raise this issue and request that the labelling requirements in Annex VI are changed back to the original wording of the Commission’s proposal, before the Regulation is implemented.

Read also our position paper on the topic and the most recent addendum on the topic.