development and application of guidance documents – industry view dr martin schaefer ecca-ecpa...
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Development and application of guidance documents – industry view
Dr Martin Schaefer
ECCA-ECPA Conference March 2014
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Introduction
Scientific Guidance documents
Example Bee guidance
Key industry concerns and proposals
Summary
Content
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Timely
Very helpful
Practical for the regulatory process
Non-controversial
Introduction: Procedural Guidance Documents
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Complex,-impact assessment for specific protection goals?-are revisions really improving safety ?
Numerous consequences if not prepared by risk assessment managers in MS
No transparent process yet foradoption and enforcement- eg dermal absorption
Introduction:Scientific Guidance Documents
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Provide predictability and consistency, for: • EU AS evaluations • MS/Zonal PPP evaluations
Be workable for all evaluators• Rules need to be developed by those using them • PPR Panel role is different to many other panels -
they do not directly evaluate substances/products
Guidance documents (GD) must…
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Example: Bee guidance document
Guidance document in its current form is not ready for implementation
Too complex, leads to risk assessment ‘dead end’
BUT could develop into a workable document…• Further work on exposure
• Reduce no. scenarios to those most relevant
• Development of appropriate tests
• Calibrate risk assessment
Involvement of stakeholders to produce workable GD– E.g. Industry, ICPPR, OECD, Member States
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What would adoption of the new bee GD mean?
Proposed risk assessment scheme lead to conclusion of potential risk to almost all products!!
Risks are expected to remain unresolved due to lack of practical or available testing tools
Impossibility to refine the risk assessment– Testing guidelines for honey bees, bumble bees and
solitary bees not available– Unrealistic higher tier testing– Lack of capacity of testing facilities
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GD: Key Concerns of industry
1. Incorrect use of guidance Application of draft guidance before finalization
2. GDs not fit for purpose – inc. for zonal evaluation Aim should be to provide clarity and harmonisation
3. Not focused on needs of risk assessors & risk managers Clearer mandate would help!
4. Not making use of relevant available data to set parameters for GDs Industry can help but EFSA need to consider submitted studies!
5. Relevant expertise and independence Experts should be able to support drafting With independent review…
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Need to ensure process for new guidance consider: – Relevance of risk assessment scenarios– Relevance of the endpoints used– Testing needs and guideline availability
Involve end users– Regulatory risk assessors– Industry risk assessors
Relevance for risk assessment
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Need to verify: – Relevance of risk assessment scenarios regarding
decision making (not restricted to “protection goals”)– Implications for existing product authorisations
(virtual vs real risks)– Implications for harmonisation– Implications on work sharing (out of Europe) and
possible inconsistencies
Involve risk managers all way through
Usefulness for decision making
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Define realistic implementation timelines on the basis of testing capacity
Plan feedback on the guidance document and adjustments
Testing phase before full implementation would be a positive step
Implementation of GD
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GD should be clear and workable - to support product authorisations! Should be developed by those using it EFSA should provide ‘scientific check’ (opinion) Industry to be consulted Clear implementation plan Should not be applied before finalisation
Summary
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Thank you!