Medical Writing Post-Approval Regulatory Writing Post-approval regulatory writing – How different is it from writing pre-approval documents?
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Volume 23, Issue 4 - Post-Approval Regulatory Writing

Post-approval regulatory writing – How different is it from writing pre-approval documents?

Abstract

Regulatory writing has various facets to it with good writing skills as a preliminary requirement. Well written reports form the basis of all regulatory submissions for marketing approval and its success largely depends on the research information presented to the regulators. Submission package should comply with the required guidelines and report structure. In addition, they should be written in a style that allows regulators easy access to the safety and efficacy information needed for making a decision on marketing the drug. Post-approval writing can present some interesting situations and challenges to the sponsor and the medical writer. It is important for a medical writer to be aware of these situations and make the necessary plans to surpass them, working with experts in different domains to ensure timely availability of the right drug to the right patients. The article describes in detail some of these situations.

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References

  1. European Medicines Agency. Dossier submission: regulatory and procedural guidance [Internet]. [cited 2014 Aug 5]. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000121.jsp&mid=WC0b01ac0580027255
  2. European Medicines Agency. Dossier format: regulatory and procedural guidance [Internet]. [cited 2014 Aug 6]. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000102.jsp&mid=WC0b01ac058002c599
  3. European Medicines Agency. Assessment templates and guidance [Internet]. [cited 2014 Aug 6]. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000337.jsp&mid=WC0b01ac0580022719
  4. ICH Harmonised Tripartite Guideline – Structure And Content Of Clinical Study Reports – E3. [1995 Nov 30; cited 2014 Aug 6]. Available from: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E3/E3_Guideline.pdf
  5. ICH Harmonised Tripartite Guideline - Guideline For Good Clinical Practice -E6(R1). [1996 Jun 10; cited 2014 Aug 6]. Available from: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guideline.pdf
  6. European Medicines Agency. Pharmacovigilance [Internet]. [cited 2014 Aug 6] Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000258.jsp&mid=WC0b01ac05800241de

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