Guidance on guidancedocument development           Wolfgang Reinert          European Commission  Health and Consumers Dir...
Guidance document on guidance documents                              What ?•   Provide procedure for producing new and rev...
Guidance document on guidance documents                                Why ?•   Acknowledge different roles of different p...
Stepwise approach•   Identify need•   Produce concept paper•   Evaluate and adopt concept paper•   Draft GD•   Discuss•   ...
History and planning•   Technical report of EFSA “Evaluation of    the European Union Pesticide Safety    review process”,...
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Wolfgang Reinert - Guidance on guidance document development

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Wolfgang Reinert - Guidance on guidance document development

  1. 1. Guidance on guidancedocument development Wolfgang Reinert European Commission Health and Consumers Directorate General Unit Chemicals, contaminants, pesticides ECPA-IBMA workshop – EFSA evaluation of PPP 26 April 2012 Health and Consumers
  2. 2. Guidance document on guidance documents What ?• Provide procedure for producing new and revising existing GDs• Define - competencies - steps to be followed in drafting - adoption procedure - adoption date• Include a (continuously updated) list of guidance documents Health and Consumers
  3. 3. Guidance document on guidance documents Why ?• Acknowledge different roles of different players• Avoid duplication of work• Improve quality and usefulness of the GDs• Improve communication and create transparency (Authorities, stakeholders, Third Countries) Health and Consumers
  4. 4. Stepwise approach• Identify need• Produce concept paper• Evaluate and adopt concept paper• Draft GD• Discuss• Adopt and set application date• Publish Health and Consumers
  5. 5. History and planning• Technical report of EFSA “Evaluation of the European Union Pesticide Safety review process”, from 27 August 2008• First draft in 2009• Drafting process interrupted…• …and restarted in 2011 Health and Consumers

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