Medical Writing Public Disclosure Policies 0070 and 0043: Juggling different requirements
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Volume 27, Issue 2 - Public Disclosure

Policies 0070 and 0043: Juggling different requirements

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References

  1. European Medicines Agency. European Medicines Agency policy on access to documents (related to medicinal products for human and veterinary use). Policy/0043. 30 Nov 2010. Available from: Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Other/2010/11/WC500099473.pdf
  2. European Medicines Agency. European Medicines Agency policy on publication of clinical data for medicinal products for human use. Policy/0070. 2 Oct 2014. Available from: Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Other/2014/10/WC500174796.pdf
  3. European Medicines Agency. Output of the European Medicines Agency policy on access to documents related to medicinal products for human and veterinary use. 30 Nov 2010. Available from: Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2010/11/WC500099472.pdf
  4. Bonini S, Eichler H, Wathion N, Rasi G. Transparency and the European Medicines Agency – Sharing of Clinical Trial Data. N Engl J Med. 2014;371(26):2452–5.
  5. European Medicines Agency. Annual Report 2016. 2017. Available from: Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Annual_report/2017/05/WC500227334.pdf
  6. European Parliament. Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data. Available from: Available from: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2001:008:0001:0022:en:PDF
  7. European Medicines Agency. Questions and answers on the European Medicines Agency policy on publication of clinical data for medicinal products for human use. Rev 1. 8 Jun 2015. Available from: Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Report/2014/10/WC500174378.pdf
  8. European Medicines Agency. External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use. Version 1.3. 20 Sep 2017. Available from: Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2017/09/WC500235371.pdf
  9. European Ombudsman. Decision in case 1602/2016/JAS on the European Medicines Agency’s handling of an access to documents request related to clinical study reports [Internet]. 8 Feb 2018 [cited 15 Mar 2018]. Available from: Available from: https://www.ombudsman.europa.eu/cases/decision.faces/en/89507/html.bookmark
  10. European Medicines Agency. Guide on access to unpublished documents. Access to unpublished documents. 26 Aug 2014. Available from: Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Other/2014/11/WC500177739.pdf
  11. Rusanov A. Drawing the boundaries of data disclosure in clinical trials –EMA’s perspective. Presented at DIA The Evolution of Policy 0070: EMA Clinical Data Publi cation Conference, London, 6– 7 Dec 2017.
  12. European Medicines Agency. Clinical data [Internet]. Available from: Available from: https://clinicaldata.ema.europa.eu/web/cdp/home
  13. Henry-Eude AS. EMA update on Clinical Data Publication (CDP). Presented at Update on the implementation of EMA policy on publication of clinical data (Policy 0070) – Industry Associations webinar [Internet]. 29 Jan 2018 [cited 7 Mar 2018]. Available from: Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/events/2018/02/event_detail_001571.jsp&mid=WC0b01ac058004d5c3
  14. European Medicines Agency. Support for industry on clinical data publication [Internet]. Mar 2018 [cited 14 Mar 2018]. Available from: Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001743.jsp&mid=WC0b01ac0580ae88cc
  15. European Medicines Agency. Questions and Answers (Q&As) on the External Guidance of Policy 0070 on Clinical Data Publication (CDP). Rev. 1. 20 Sep 2017. Available from: Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2017/04/WC500225881.pdf
  16. Article 29 Data Protection Working Party. Opinion on anonymisation techniques [Internet]. Apr 2014 [cited 7 Mar 2018]. Available from: Available from: http://www.dataprotection.ro/servlet/ViewDocument?id=1085
  17. PhUSE De-Identification Working Group. PhUSE De-identification Standard for CDISC SDTM 3.2 [Internet]. 20 May 2015 [cited 7 Mar 2018]. Available from: Available from: https://www.phuse.eu/data-transparency
  18. TransCelerate BioPharma Inc. Deidentification and anonymization of individual patient data in clinical studies. A model approach [Internet]. 2017 [cited 7 Mar 2018]. Available from: Available from: http://www.transceleratebiopharmainc.com/wp-content/uploads/2015/04/TransCelerate-De-identification-and-Anonymization-of-Individual-Patient-Data-in-Clinical-Studies-V2.0.pdf
  19. El Emam K. An Analysis of Anonymization Practices in Initial Data Releases Pursuant to EMA Policy 0070. Appl Clin Trials [Internet]. 13 Apr 2017 [cited 3 Mar 2018]. Available from: Available from: http://www.appliedclinicaltrialsonline.com/analysis-anonymization-practices-initial-data-releases-pursuant-ema-policy-0070?pageID=1
  20. Henry-Eude AS. EMA Updates on Policy 0070 / Clinical Data Publication. Presented at DIA The Evolution of Policy 0070: EMA Clinical Data Publication Conference, London, 6–7 Dec 2017.
  21. Heads of Medicines Agencies and European Medicines Agency. HMA/EMA guidance document on the identification of commercially confidential information and personal data within the structure of the marketing authorisation (MA) application – Release of information after the granting of a marketing authorisation. 9 Mar 2012. Available from: Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Other/2012/03/WC500124536.pdf
  22. European Medicines Agency. Press release. General Court confirms EMA approach to transparency [Internet]. 6 Feb 2018 [cited 7 Mar 2018]. Available from: Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2018/02/WC500243216.pdf
  23. European Parliament. 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. Available from: Available from: http://ec.europa.eu/health/files/eudralex/vol-1/reg_2014_536/reg_2014_536_en.pdf
  24. Department of Health and Human Services. Clinical Trials Registration and Results Information Submission; Final Rule. Fed Regist 2016; 81:64981–5157. Available from: Available from: https://www.gpo.gov/fdsys/pkg/FR-2016-09-21/pdf/2016-22129.pdf
  25. Food and Drug Administration. Clinical Data Summary Pilot Program [Internet]. Available from: Available from: https://www.fda.gov/Drugs/DevelopmentApprovalProcess/ucm589210.htm
  26. Health Canada. Draft Guidance Document. Public Release of Clinical Information [Internet]. 10 Apr 2018 [cited 23 Apr 2018]. Available from: Available from: https://www.canada.ca/content/dam/hc-sc/documents/programs/consultation-public-release-clinical-information-drug-submissions-medical-device-applications/draft-guide-public-release-clinical-information.pdf
  27. Kroll, S, Holtzople, J, Adriano, A, Poulimenou, D. EMA Policy 0070 Lessons Learned. Joint Presentation between Industry and EMA. Presented at DIA The Evolution of Policy 0070: EMA Clinical Data Publication Conference, London, 6– 7 Dec 2017.

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President’s Message
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The Regulatory Public Disclosure Special Interest Group
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Navigating the EMA clinical data website
Anonymisation reports from 2016 to 2017: A preliminary analysis
Preparing anonymisation reports in general and for an orphan drug in particular
Policies 0070 and 0043: Juggling different requirements
Clinical data publication by the EMA: The challenges facing the pharmaceutical industry
Clinical trial results disclosure on ClinicalTrials.gov and EudraCT
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Lay titles for clinical trials: A balancing act
Why clinical study reports really matter
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Preparing clinical study reports for external sharing
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An interview with Chris Winchester
Journal Watch
In the Bookstores
Good Writing Practice
Medical Devices
Getting Your Foot in the Door
Out on Our Own
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