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  • 1.  Release of Investigational Product in EU

    This message was posted by a user wishing to remain anonymous
    Posted 09-Jul-2018 16:23
    This message was posted by a user wishing to remain anonymous

    Hello Everyone,

    Our investigational product has been released in the US for Phase 1 clinical trial. Currently, we have a collaborator from EU who will be using the investigational product for a different indication. Our collaborator will conduct the Phase 1 clinical trial in EU. Since we are not experts on EU regulations, I would like to ask the following questions to the forum:

    1. Could our EU collaborators release the product using the same testing results from the US? Is product re-testing at the EU mandatory to release the product?

    2. Is the qualified person in Articles 48, 49, 50 of Regulation (EU) No 536/2014 essentially a "quality control" person?

    3. Is it mandatory to send the Batch Record to our EU collaborators to release the product?

    Thank you very much for sharing your thoughts.


  • 2.  RE: Release of Investigational Product in EU

    Posted 10-Jul-2018 09:10
    First, you You will need to have a QP in the EU review the information and only the QP can release the product.  A QP certificate and batch records are required to be submitted along with the Clinical Trial Application in the country that the Phase 1 study is planned to be conducted.  Each Competent Authority has slightly different regulations and CTA submission requirements, but usually involves an IMPD that is made up mostly of details of the quality information of the product (similar to Module 3) with the clinical and nonclinical information being summarized in the Investigator Brochure.  Also note that the study needs to be registered in the clinical trial registry (EUDRACT) system.

    A QP is a "quality person," but their qualifications are pretty strict and they are registered in a member state.

    This is very basic information, but should get you started in how you need to think about it.

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    Glen Park
    Jersey City NJ
    United States
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    Original Message


  • 3.  RE: Release of Investigational Product in EU

    Posted 10-Jul-2018 09:53

    The Clinical Trial Regulation is not yet in force, so your collaborator will be running under the (old) Clinical Trials Directive 2001/20/EC. When it finally does take effect there is a transition period. The directive functions in that it was transformed into national law by each member state of the EU, so check the national health authority website for any additional information that may be unique to that country.
    There is information here and links to the directive and to the GMP requirements (aka "Annex 13"), including labels.
    I assume your collaborator is experienced in CTAs in the EU and knows what they are doing, since they have to register the trial as well, and it works differently than in the US (not product based, but protocol based).

    Clinical trials - Public Health - European Commission

    https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/2009_06_annex13.pdf

    1. Your EU collaborators will have to release the product, or more to the point, their QP will.
    2. The Qualified Person (QP) is not just a "quality control" person. The QP role is defined, and includes a (usually pharmacy) degree plus experience and the person is certified/registered by the health authority of their national country. There is no US equivalent I think.
    3. The EU QP will surely want the batch record in order to release the product.



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    Monica Dommel-Schorstein
    Senior Regulatory Affairs Specialist
    Bavarian Nordic
    Munich - Germany
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    Original Message


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