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Solution for Expiry Labels, DtP, and Study Timelines Due to EU 536/2014 Clinical Trials Regulation

The new regulation improves many aspects of clinical preparation and activation but brings certain new challenges for sponsors.


Quick hits:

  • The regulation is switching the emphasis from the first country and site approved to the last country and site ready.
  • The regulation has strict timelines sponsors must adhere to, with the submission process being split into two parts for the reporting country and the member states concerned.
  • Annex VI chapter nine of the regulation stipulates that the expiration date is required to be printed on the label, which leads to challenges with relabeling and more.
  • The industry is proactively searching for and providing guidance on potential solutions to these challenges, though no one solution will be a fix-all and many are not yet approved by the European Commission.

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Read article   Read the transcript below:

Hi, I’m Melissa Griffen, Contributing Editor at Healthcare Packaging. Regulation EU No 536/2014 on clinical trials—which is a binding legislative act for each member state, overruling national law—is coming into force on January 31, 2022, to simplify clinical trial preparation and activation. With it will come many changes that will impact the clinical sponsors’ preparation, submission process, and administration methods.

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