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Phase I studies in EU: due change in compliance and transparency under the EU clinical trials regulation

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Notes

  1. Regulation (EU) No 536/2014 of the European parliament and of the council of 16 april 2014 on clinical trials on medicinal products for human use, and repealing directive 2001/20/EC.

  2. Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use.

  3. EMA/42176/2014 Rev. 1, Corr.*—Compliance and Inspections—functional specifications for the EU portal and EU database to be audited (March 2015).

  4. EMA/129363/2015 Final—Compliance and Inspections—revision of Sect. 6 of the “Functional specifications for the EU portal and EU database to be audited—EMA/42176/2014” setting out features to support making information public (March 2015).

  5. EMA/228383/2015 Endorsed—Appendix, on disclosure rules, to the “Functional specifications for the EU portal and EU database to be audited—EMA/42176/2014” (October 2015).

  6. EC/726/2004 Regulation (EC) No 726/2004 laying down community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (Consolidated version: 28/01/2019) [Art 57(2)].

    available at: https://www.gmp-navigator.com/files/guidemgr/Regulation%20726_2004%202019.pdf

  7. Eudralex Volume 10 Implementing Guideline 2008/C168/02—Communication from the commission regarding the guideline on the data fields contained in the clinical trials database provided for in Article 11 of Directive 2001/20/EC to be included in the database on medicinal products provided for in Article 57 of Regulation (EC) No 726/2004.

    avilable at: https://www.gmp-compliance.org/files/guidemgr/c_16820080703en000300041.pdf

  8. Regulation (EC) No 1901/2006 for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 [Art 41(2)].

    available at: https://www.gmp-navigator.com/files/guidemgr/Regulation%201901_2006%202019.pdf

  9. Eudralex Volume 10 Implementing Guideline 2012/C 302/03 Commission Guideline — Guidance on posting and publication of result-related information on clinical trials in relation to the implementation of Article 57(2) of Regulation (EC) No 726/2004 and Article 41(2) of Regulation (EC) No 1901/2006.

  10. European Medicines Agency. European Medicines Agency policy on publication of clinical data for medicinal products for human use. Policy/0070 (Oct 2018).

  11. European Medicines Agency. European Medicines Agency policy on access to documents (related to medicinal products for human and veterinary use). Policy/0043 (Oct. 2018).

  12. ICMJE Recommendations – Clinical Trials – Registration.

    available at: http://www.icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html (downloaded 03.Feb.2022).

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  1. ACPS - Applied Clinical Pharmacology Services, Viktoriastrasse 4, 65189, Wiesbaden, Germany

    Christian Martin De Mey

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  1. Christian Martin De Mey
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Correspondence to Christian Martin De Mey.

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De Mey, C.M. Phase I studies in EU: due change in compliance and transparency under the EU clinical trials regulation. Eur J Clin Pharmacol 78, 1047–1048 (2022). https://doi.org/10.1007/s00228-022-03293-3

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