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

Sunil Modali

Volume 23, Issue 4 - Post-Approval Regulatory Writing

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

Author: Sunil Modali

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.

Keywords: Pre-approval writing, Post-approval writing, Submission package, Sponsor, Guidelines, Regulatory agency

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References

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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
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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?

Author: Sunil Modali

Abstract

References

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