Medical Writing Post-Approval Regulatory Writing Non-interventional Post-Authorisation Safety Studies (NI-PASS): A different type of report

Volume 23, Issue 4 - Post-Approval Regulatory Writing

Non-interventional Post-Authorisation Safety Studies (NI-PASS): A different type of report

Abstract

Although Post-Authorisation Safety Studies (PASS) have been around since 2001, most regulatory writers would have been unaware of their existence until the recent changes in European regulations, which include mention of these studies as part of general strengthening of pharmacovigilance procedures. Interventional PASS will largely adhere to International Conference on Harmonisation requirements, but non-interventional (NI) PASS should be reported according to a particular mandated format, which may appear strange to writers used to drafting clinical study reports for interventional trials. Given their novelty, there is no consensus as to how these reports should be drafted. This article addresses the structure of NI-PASS reports and provides an interpretation, albeit preliminary, of the corresponding European Medicines Agency guidance text.

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References

  1. Guideline on good pharmacovigilance practices (GVP): Module VIII – Post-authorisation safety studies (Rev 1). 19 April 2013. EMA/813938/2011 Rev 1. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500129137.pdf
  2. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use. Official Journal of the European Communities L 311/67. 28.11.2001. Available from: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2001:311:0067:0128:en:PDF
  3. EU PAS Register Guide. European Medicines Agency. 28 July 2014, EMA/613603/2012. Available from: http://www.encepp.eu/publications/documents/EUPASRegisterGuide.pdf
  4. Guidance for the format and content of the final study report of non-interventional post-authorisation safety studies. 30 July 2013. EMA/48663/2013. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2013/01/WC500137939.pdf
  5. Guidance for the format and content of the protocol of non-interventional post-authorisation safety studies. 26 September 2012. EMA/623947/2012. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Other/2012/10/WC500133174.pdf

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Strategic medical writing in the post-authorisation phase
Non-interventional Post-Authorisation Safety Studies (NI-PASS): A different type of report
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The EMWA Budapest Working Group: A 2-year collaboration to make recommendations for aligning the ICH E3 guideline with current practice and developing clinical study protocol guidance
Profile: An interview with Esther Moreno Barriuso: On some fundamental concerns of medical interpreting
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