Use of Risk-based Approach for Regulating CMC Changes to Approved Applications FDA Public Meeting February 7, 2007.

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Presentation transcript:

Use of Risk-based Approach for Regulating CMC Changes to Approved Applications FDA Public Meeting February 7, 2007

Genentech Supports Proposed Revisions to Implements objectives of FDA 21 st Century Pharmaceutical CGMP Initiative Implements objectives of FDA 21 st Century Pharmaceutical CGMP Initiative Embraces global quality initiatives defined in ICH Q8, Q9 and Q10 Embraces global quality initiatives defined in ICH Q8, Q9 and Q10 Facilitates manufacturing process innovations and improvements Facilitates manufacturing process innovations and improvements Allows for more rapid and predictable release of life saving medicines Allows for more rapid and predictable release of life saving medicines

Genentech Concerns about Proposed Revisions to FDA should revise both and FDA should revise both and FR notice only addresses revisions to FR notice only addresses revisions to Many natural and recombinant DNA-derived products regulated under Many natural and recombinant DNA-derived products regulated under No scientific and technical reason that biotech products regulated under should be treated differently No scientific and technical reason that biotech products regulated under should be treated differently April 8, 2004 final rule on changes to approved applications applied to drugs and biologics April 8, 2004 final rule on changes to approved applications applied to drugs and biologics Ensure consistency in handling manufacturing changes for specified biotech products Ensure consistency in handling manufacturing changes for specified biotech products

Genentech Concerns about Proposed Revisions to Need effective team work between CMC reviewer and Field Investigator Need effective team work between CMC reviewer and Field Investigator Clear communication Clear communication Uniform expectations Uniform expectations Shared understanding of regulatory agreements Shared understanding of regulatory agreements Harmonize respective variation regulations with other international regulatory agencies Harmonize respective variation regulations with other international regulatory agencies