The Parallel Universes of Eudralex Vol 10

Did you know that we now have two versions of Eudralex volume 10?  There is the current version which applies now and there is a parallel version which will apply once the Clinical Trials Regulation comes into effect, which is anticipated to be mid 2020 at the time of writing.

It does feel a little like we are stuck between two states of being in terms of clinical trials regulation in the EU, or possibly even three if you are based in the UK and awaiting clarity on Brexit!

It is important to be clear that the “old” version of the various guidelines still apply until the CT Regulation comes in, and I’m coming across some confusion as to where we are up to right now, so I’m going to try to summarise what changes will come in with the Regulation – the image below is what you see when you visit the Eudralex vol 10, and you can toggle between the two versions.

parallel Eudralex vol 10

So remember – everything you see below is not yet applicable, this is just to let you know what’s already been published and what is still to come.

Chapter I – Approvals (CTA, Ethics and Central Database)

New guidance is not yet available and will be added later

Chapter II – Safety Reporting

ICH E2F will still apply.  Detailed guidance on AE reporting is covered in the Q&A document on the CT Regulation in chapter 5, so it looks like the current guidance will be removed.

Chapter III – IMP

New versions of existing guidelines have been published and are available in the parallel version of Eudralex Vol 10:

  • New version of Annexe 13
  • New template for batch release
  • New guidelines for quality documentation for IMPs and biological IMPs.
  • Guideline on IMPs and Non-IMPs replaced by guideline on AxMPs.

    bunch of white oval medication tablets and white medication capsules
    Photo by Pixabay on

Template for QP release and Basic Format for Manufacturers Authorisation are the same at the moment.

Chapter IV – Inspections

All inspection guidelines have been updated for implementation with the new CT Regulation.  However, the updated guideline on inspections of Phase I units is on hold until the new guideline on Risk Mitigation for First in Human trials is finalised.

Chapter V – additional documents

New documents added are:

  • Q&A document on the CT Regulation – this is not yet final as some topics are still being discussed.
  • Risk Proportionate approaches for clinical trials
  • Summary of clinical trial results for laypersons

Documents which have been updated:

  • Strategies to identify and mitigate risks for first in human clinical trials
  • Ethical considerations for clinical trials on medicinal products conducted with minors

Guidelines still being updated:

  • GCP for ATMPs
  • Content of TMF and archiving
  • Guidelines remaining in place: ICH GCP E6 (R2)

New Guideline being developed:

  • Serious Breaches – draft version published

Chapter VI – Legislation

New Legislation:

  • Clinical Trials Regulation: 536/2014
  • Implementing Regulation on Inspections: 2017/556
  • Implementing Regulation on GMP for IMPs: 2017/1569

Legislation which will be removed:

  • Clinical Trials Directive (2001/20/EC)
  • GCP Directive (2004/28/EC)
  • GMP Directive (2003/94/EC)

So that’s where we are now – this is complete and accurate to the best of my knowledge, but I can’t make any guarantees.  If you think I’ve missed something, or made a mistake please let me know.

Still confused?  Get in touch about some training for your team e-mail me on or complete the contact form.

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