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Thread: The EU Clinical Trials Regulations 2016 - implentation in the UK?

  1. #1
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    The EU Clinical Trials Regulations 2016 - implentation in the UK?

    Hello

    This is my first post. I have a query regarding the new EU Clinical Trials Regulations that are coming into force next year. Does anyone know if there is a date agreed for implementation in the UK? I'm aware it should come into force over the summer but dates not yet confirmed.

    Also is there a summary of changes available for reference? I have been through and marked out what the changes are just want to check if there is anything I may have missed.

    Does anyone know if the 25 years for archiving would apply from when the regulation comes into force or if it would apply retrospectively to studies already archived?

    Many thanks in advance for your help.

    BW

    Shahnaz

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    Hi Shehnaz,
    Welcome to the Forum. I hope that the MHRA will reply to you.

    With regard to when the CTR "applies" in the UK (and all member states), it "applies" "from six months after the publication of the notice referred to in Article 82(3), but in any event no earlier than 28 May 2016". The Article 82(3) notice is the notice that on the "basis of an independent audit report, ... the Commission ... has verified that the EU portal and the EU database have achieved full functionality and the systems meet the functional specifications drawn up". So this means that until there is this notice from the Commission, and six months has elapsed, no Member State will apply the CTR. So it is all dependent upon the EU Portal. Until that notice is published no exact date for the CTR applying can be made.

    By "summary of changes" I assume that you mean, what is different from previous UK GCP requirements? I don't know of any document like this. I know that there are some, not-for-profit professional Associations, to do with Research Quality, that have produced webcasts on what is different, from a GCP perspective. It would be useful to view them.

    Laws are seldom retrospective, because of the legal nightmare that causes. I would assume that only for those clinical trials (CTs) submitted through the CTR, would the 25 year archiving requirement be applied. This would be for applicable CTs, when the CTR "applies" not from when it comes into "force" (see above).

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    Dear Shahnaz, I have been checking to see if anyone had replied to you since this post went up and I am imagining there might be a few people out there with answers for you, but we are all in a 'watch and wait' mode until further guidance documents are released by the EU Commission.

    I am by no means a regulatory expert but am happy to provide my understanding and I welcome other members of the forum to add to this, based on what is happening within their organisations.

    It is my understanding that :
    The Regulation 536/2014 will be applied NO EARLIER than 28 May 2016. For any trials that have been submitted under the existing Clinical Trials Directive i.e. currently ongoing, then those trials can continue under that Clinical Trials Directive for 3 years.

    Please note that the EU Commission is working on the EU portal that will be used by organisations to submit their electronic regulatory applications in accordance with the Regualtion. The readiness of the portal will be important in deciding when the Regulation can be implemented e.g. if there is no functioning portal available, then the process for single electronic appilications cannot occur. I have seen it mentioned that the Regulation only becomes effective 6 MONTHS after the portal has been declared fully functional (this can be no earlier than 28th May 2015).

    I am not aware of any summary of changes e.g. Directive vs Regulation. If anyone knows of it, it would be useful to share on this forum or indicate where it is available.

    The 25 years for TMF archiving, I would not be sure of a correct answer there : maybe this will be clarified in further guidance documents. As I understand it, further guidance documents could be released by the EU Commission, EMA and possibly the CTFG.

    That is the best I can offer so it would be good to see what other comments people may have.
    Best wishes,
    FW

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    Hi Shahnaz,

    I am particularly interested in this implementation date and have searched for any updates and thought that you might find the following of interest:

    There is a link on the EMA website to the following document:
    Functional specifications for the EU portal and EU database to be audited: (http://www.ema.europa.eu/docs/en_GB/...C500179339.pdf)

    This gives some details of what the portal would do and the underlying database that will be used for clinical trials. It is 16 pages long and is not grippingly exciting stuff as it just describes the elements of functionality that must be included by law. This was signed off in April 2015.

    There is a working group: “clinical trials information system expert group” and the only update or status report available gives the following:

    1. EU PORTAL AND EU DATABASE

    1.1. EMA process and milestones
    The EMA is currently drafting the detailed rules and criteria on what data and documents are to be made public, i.e. the draft appendix on data transparency to the “functional specifications for the EU portal and database to be audited”. The draft appendix will be submitted for endorsement to the EMA Management Board in October 2015. For this purpose, the EMA is consulting the European Commission, the Member States and organised separate stakeholder meetings for the pharmaceutical industry, academic researchers, healthcare professionals and patient organisations in June (see section1.2).
    The overall final timeline regarding the design and development of the EU portal and the EU database will be announced by the EMA by “mid 2015”. The EMA team responsible for building the IT system and infrastructure for the EU portal and the EU database is being set up and will start working with full capacity in the fourth quarter of 2015. It is expected that it will take around 10 months from the point when the system is ready for audit until the Clinical Trials Regulation (CTR) applies. It is therefore likely that the CTR will not apply before the second quarter of 2017.

    So, given the complexities of the database/portal and the inclusion of all the national authorities requirements etc. the 2nd quarter of 2017 might even be optimistic.

    Gordon
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    Thank you all for the replies posted here, very informative

    Best wishes

    Shahnaz

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    Hi Shanaz, Here is an update in case you haven't seen it about the timelines for implementation of the EU CTR 536/2014, plannedfor October 2018, pending audting of the EU database and portal.

    http://www.ema.europa.eu/docs/en_GB/...C500199078.pdf

    I attach a screenshot, but if you can't see it clearly, it is within the pdf document in the link above.

    Best regards,
    Fiona
    Attachments Pending Approval Attachments Pending Approval

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    You should remember that the EMA said that :- "This is a maximum timeline and every effort will be made to bring the Regulation into application as soon as possible....progress of implementation of the system will be closely monitored ...and hence application of the Regulation to an earlier time as possible".
    The EU clinical trials portal and Union database stakeholders meeting (08Dec2015) their plan, stated (information issued 15 Dec 2015), that the regulation would apply from 4Q 2017.

    So the timeline of Oct 2018 is a maximum, but the people working on the portal think that the Regulation may apply from 4Q2017. Be prepared!

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    The EU clinical trials portal and Union database stakeholders meeting (Feb 2016) has now updated their timeline and it is the same as the EMA document - regulation applies Oct 2018. But it should still be remembered that :- "This is a maximum timeline and every effort will be made to bring the Regulation into application as soon as possible....progress of implementation of the system will be closely monitored ...and hence application of the Regulation to an earlier time as possible".

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