Guidance on developing guidance documents

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Technologie

Guidance on guidance
document 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

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

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

Stepwise approach

• Identify need
• Produce concept paper
• Evaluate and adopt concept paper
• Draft GD
• Discuss
• Adopt and set application date
• Publish

Health and
Consumers

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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Guidance on developing guidance documents

1. Guidance on guidance document 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. 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. 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. 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. 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

Guidance on developing guidance documents

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Guidance on developing guidance documents