Medical Writing Non-Clinical Health Writing Pesticide dossiers, an opportunity for medical writers
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Volume 23, Issue 3 - Non-Clinical Health Writing

Pesticide dossiers, an opportunity for medical writers

Abstract

Pesticides, also known as crop protection products, are approved for sale through a process similar to that for authorising human medicines. For example, the toxicology data submitted are nearly identical to the nonclinical data generated for a drug, and the environmental risk assessment is similar in many ways to the risk assessment for human medicines. Consequently, an experienced medical writer could prepare a pesticide dossier. This article briefly describes the regulatory requirements for preparing a pesticide dossier and where to find detailed guidance and examples to help a medical writer with this type of regulatory document.

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References

  1. The 2011 European Union report on pesticide residues in food. EFSA J 2014;12(5):3694. [cited 2014 May 31]. Available from: http://www.efsa.europa.eu/en/efsajournal/pub/3694.htm
  2. OECD Guidance Documents for Pesticide Registration. Dossier Guidance (For Industry). Chemical Plant Protection Products. Revision 2 May 2005. [cited 2014 May 31]. Available from: http://www.oecd.org/env/ehs/pesticides-biocides/oecdguidancedocumentsforpesticideregistration.htm#dossier
  3. OECD Guidance Documents for Pesticide Registration [cited 2014 May 31]. Available from: http://www.oecd.org/env/ehs/pesticides-biocides/oecdguidancedocumentsforpesticideregistration.htm#dossier
  4. Guidance Document for Applicants on Preparing Dossiers for the Approval of a Chemical New Active Substance and for the Renewal of Approval of a Chemical Active Substance According to Regulation (EU) No 283/2013 and Regulation (EU) No 284/2013. SANCO/10181/2013–rev. 2.1. 13 May 2013. [cited 2014 May 31]. Available from: http://ec.europa.eu/food/plant/pesticides/approval_active_substances/docs/guidance_document_for_applicants_on_preparing_dossiers_en.doc
  5. EFSA Register of Questions. Pesticide Dossiers [cited 2014 May 31]. Available from: http://registerofquestions.efsa.europa.eu/roqFrontend/?wicket:interface=:1::::.
  6. Computer Aided Dossier and Data Supply (CADDY) [cited 2014 May 31]. Available from: http://caddy.ecpa.eu/caddy_xml/downloads/
  7. European Commission Directorate General for Health & Consumers. Plants. Pesticides. Techincal and Procedural guidance [cited 2014 May 31]. Available from: http://ec.europa.eu/food/plant/pesticides/approval_active_substances/guideline_documents_en.htm
  8. Cooperation in the North Zone. Guidance document on work-sharing in the Northern zone, version 3.0.) [cited 2014 May 31]. Available from: http://mst.dk/82462.aspx
  9. European Commission Directorate General for Health & Consumers. Legislation on pesticides. Contact points [cited 2014 May 31]. Available from: http://ec.europa.eu/food/plant/pesticides/legislation/docs/national-authorities_en.pdf
  10. UK CRD Events for 2014/15 [cited 2014 May 31]. Available from: http://www.pesticides.gov.uk/OneStopCMS/Core/TemplateHandler.aspx?NRMODE=Published&NRNODEGUID=%7b2CCAE9C5-324B-4534-9DAF-105B3E8184D8%7d&NRORIGINALURL=%2fguidance%2findustries%2fpesticides%2ftopics%2fAbout-The-Chemicals-Regulation-Directorate%2fevents&NRCACHEHINT=NoModifyGuest
  11. 14th Annual AgChem Forum, 9–10 Sept 2014, Barcelona, Spain [cited 2014 May 31]. Available from: http://www.informa-ls.com/event/agchemforum14
  12. European Crop Protection Association – European Regulatory Conference. March 12, 2014. [cited 2014 May 31]. Available from: http://www.ecpa.eu/event/regulatory-affairs/crop-protection-european-regulatory-conference
  13. European Food Safety Authority Topics. Pesticides [cited 2014 May 31]. Available from: http://www.efsa.europa.eu/en/topics/topic/pesticides.htm

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