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Policy Development and Guidance

Policy Development and Guidance . Jon Clark OPS Associate Director for Policy Development. GMP for 21st Century . Some CMC guidance documents are out of synchronization with new thinking Guidance process has strong and weak points Strength is in technical input from staff scientists

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Policy Development and Guidance

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  1. Policy Development and Guidance Jon Clark OPS Associate Director for Policy Development

  2. GMP for 21st Century • Some CMC guidance documents are out of synchronization with new thinking • Guidance process has strong and weak points • Strength is in technical input from staff scientists • Weakness is in decision making process for drafts

  3. Draft cycling CMCCC Body Review Teams CMCCC Body CMCCCWorking Group OPS Edit Legal Edit Public Comment

  4. Time Consuming Process • Rapid change in FDA thinking • Leaves slower efforts to “catch up” • Guidance development is a slower process • Investment of Time • Documents may be slow, but they have momentum • Guidance Content and New Direction are managed by different groups

  5. Actions Taken • Move coordinating and decision making from CMCCC working group to OPS Office • OPS Coordinating Committee (OPS CC) • Moves Guidance content management to OPS • Disband CMCCC • Mandate OPS CC to recruit technical input from scientists

  6. New Process Science input from selected Teams OPS CC OPS Edit Legal Edit Public Comment

  7. Synchronization Effort • Revision of drafts • Public comment recycle • Withdrawal of Documents • Mainly for finalized Guidance documents • Enforcement Discretion • Guidance to address regulation requirements

  8. Consider Options OTG • Other Than Guidance • Question and Answer Format • Post on public Internet • Keep it Simple • Manual of Policy and Procedure (MAPP) • If/Then format-Directed toward OPS staff • Publicly available • More rapid and flexible

  9. Guidance • Risk based approach • Reverse recent tendency toward proscription and prescription • Manufacturer chooses technology and approach to problem solving • Focus efforts on assurance of reliable product quality and not technology

  10. Input to Our Processes • What do you think? • Is there potential gain from formation of a “Fact Finding Group” to help us determine how we move toward the “Desired State?” • Do we need all the Guidances? • Where are they incongruent? • Provide advice as to what Guidance Industry needs as we work toward a new regulatory paradigm. • Prioritization

  11. End

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