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Implementation of the CTD: CBER’S Perspective

C. B. E. R. Implementation of the CTD: CBER’S Perspective. May 8, 2001 Joan Wilmarth Blair, M.A. International Affairs Advisor CBER/FDA. I nternational C onference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use.

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Implementation of the CTD: CBER’S Perspective

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  1. C B E R Implementation of the CTD:CBER’S Perspective May 8, 2001 Joan Wilmarth Blair, M.A. International Affairs Advisor CBER/FDA

  2. International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use

  3. International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticalsfor Human Use

  4. BIOLOGICAL PRODUCTSREGULATED BY CBER Vaccines Plasma Derivatives Monoclonal Antibodies Allergenic Extracts Biotech DerivedTherapeutics BloodComponents Peptides Whole Blood SomaticCell & GeneTherapy Blood Related Devices Tissues Xenotransplantation

  5. Q6B: Specifications,Test Procedures & Acceptance Criteria for Biotechnological/ Biological Products Scope: “…apply to proteins & polypeptides, their derivatives, & products of which they are components (e.g., conjugates)” “…does not cover antibiotics, synthetic peptides & polypeptides, heparins, vitamins, cell metabolites, DNA products, allergenic extracts, conventional vaccines, cells, whole blood, and cellular blood components”

  6. BIOLOGICAL PRODUCTSREGULATED BY CBER Vaccines Plasma Derivatives Monoclonal Antibodies Allergenic Extracts Biotech DerivedTherapeutics BloodComponents Peptides ICH Whole Blood SomaticCell & GeneTherapy Blood Related Devices Tissues Xenotransplantation

  7. CTD application format only applicable to BLAs for this subset of products? Vaccines Plasma Derivatives Monoclonal Antibodies Allergenic Extracts Biotech DerivedTherapeutics BloodComponents Peptides ICH CTD? Whole Blood SomaticCell & GeneTherapy Blood Related Devices Tissues Xenotransplantation

  8. BLA - Section 601.2Application for Biologics Licenses • Describes content of application • Describes procedures for filing

  9. NDA - Section 314.50Content and Format of Application • Describes form and content, e.g., • Application form • Numbers of copies (archival copy) • Index • Summaries • Case report tabulations • Case report forms • Labeling • etc.

  10. The question is NOT “Will CBER be accepting the CTD instead of the BLA?” The question being asked is “Will the CTD application format be applicable to all BLAs?”

  11. NDA - Section 314.50 Describes content of application Describes procedures for filing Describes format BLA - Section 601.2 Describes content of application Describes procedures for filing DOES NOT describe format Application Format - Regulatory Requirements?

  12. Migration from ELA/PLA to BLA Construct BLA req’ments and Form 356h format • ELA/PLA • Req’ments Issue guidance for content & format for product categories

  13. BLA/Form 356h  Issuance of Guidances • 8/96: Therapeutic rDNA-derived products and monoclonal antibody products for in vivo use • 1/97: Autologous somatic cell therapy products • 1/99: Vaccines & related products • 2/99: Plasma derivatives, animal plasma, serum-derived products • 3/99: Biological in-vitro diagnostics • 4/99: Allergenic extracts or allergen patch tests • 5/99: Human blood & blood components

  14. BLA Content • Req’ments • “CMC” guidance • “CMC” guidance • “CMC” guidance Formatting of BLA to CTD Construct CTD BLA Revise guidance for new format

  15. CBER’s Acceptance of CTD • Question of acceptance of CTD format prior to issuance of guidance • Use of CTD format not precluded in advance of guidance • URGE early communication -- assure all required content included in submission

  16. CBER’s CTD Implementation Process • Revise “CMC” guidances to map CTD to BLA • “Specified Products” currently in process • Staff training • Workshops likely

  17. Integration of CTD with Applications for Product Approval

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