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Implementation of the CTD:Implementation of the CTD:CBER’S PerspectiveCBER’S Perspective
Implementation of the CTD:Implementation of the CTD:CBER’S PerspectiveCBER’S Perspective
May 8, 2001
Joan Wilmarth Blair, M.A.International Affairs Advisor
CBER/FDA
May 8, 2001
Joan Wilmarth Blair, M.A.International Affairs Advisor
CBER/FDA
CC BB
EE RR
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International Conference on
Harmonisation of TechnicalRequirements for the Registration ofPharmaceuticals for Human Use
International Conference on
Harmonisation of TechnicalRequirements for the Registration ofPharmaceuticals for Human Use
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International Conference on
Harmonisation of TechnicalRequirements for the Registration of
Pharmaceuticals for
Human Use
International Conference on
Harmonisation of TechnicalRequirements for the Registration of
Pharmaceuticals for
Human Use
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BIOLOGICAL PRODUCTSREGULATED BY CBER
Whole BloodWhole BloodSomaticSomatic
Cell & GeneCell & GeneTherapyTherapy
BloodBloodComponentsComponents
Allergenic ExtractsAllergenic Extracts
Plasma DerivativesPlasma Derivatives VaccinesVaccines
Monoclonal AntibodiesMonoclonal AntibodiesBiotech DerivedBiotech Derived
TherapeuticsTherapeutics
TissuesTissues XenotransplantationXenotransplantation
Blood Related DevicesBlood Related Devices
PeptidesPeptidesPeptidesPeptides
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Q6B: Specifications,Test Procedures & Acceptance Criteria for Biotechnological/Biological Products
Q6B: Specifications,Test Procedures & Acceptance Criteria for Biotechnological/Biological Products
Scope: “…apply to proteins & polypeptides, theirderivatives, & products of which they are components (e.g., conjugates)”
“…does not cover antibiotics, syntheticpeptides & polypeptides, heparins, vitamins, cell metabolites, DNA products, allergenic extracts, conventional vaccines, cells, whole blood, and cellular blood components”
Scope: “…apply to proteins & polypeptides, theirderivatives, & products of which they are components (e.g., conjugates)”
“…does not cover antibiotics, syntheticpeptides & polypeptides, heparins, vitamins, cell metabolites, DNA products, allergenic extracts, conventional vaccines, cells, whole blood, and cellular blood components”
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BIOLOGICAL PRODUCTSREGULATED BY CBER
Whole BloodWhole BloodSomaticSomatic
Cell & GeneCell & GeneTherapyTherapy
BloodBloodComponentsComponents
Allergenic ExtractsAllergenic Extracts
Plasma DerivativesPlasma Derivatives VaccinesVaccines
Monoclonal AntibodiesMonoclonal AntibodiesBiotech DerivedBiotech Derived
TherapeuticsTherapeutics
TissuesTissues XenotransplantationXenotransplantation
Blood Related DevicesBlood Related Devices
ICHICH PeptidesPeptidesPeptidesPeptides
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Whole BloodWhole BloodSomaticSomatic
Cell & GeneCell & GeneTherapyTherapy
BloodBloodComponentsComponents
Allergenic ExtractsAllergenic Extracts
Plasma DerivativesPlasma Derivatives VaccinesVaccines
Monoclonal AntibodiesMonoclonal AntibodiesBiotech DerivedBiotech Derived
TherapeuticsTherapeutics
TissuesTissues XenotransplantationXenotransplantation
Blood Related DevicesBlood Related Devices
ICH CTD?ICH CTD? PeptidesPeptidesPeptidesPeptides
CTD application format only applicable to BLAs for this subset of products?
CTD application format only applicable to BLAs for this subset of products?
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BLA - Section 601.2Application for Biologics Licenses
Describes content of application
Describes procedures for filing
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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.
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The question is NOT “Will CBER be accepting the CTD instead of the BLA?”
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?”
The question being asked is “Will the CTD application format be applicable to all BLAs?”
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Application Format - Regulatory Requirements?
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
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BLA req’mentsand Form 356hformat
BLA req’mentsand Form 356hformat
ELA/PLA Req’ments
ELA/PLA Req’ments
Migration from ELA/PLA to BLA ConstructMigration from ELA/PLA to BLA Construct
Issue guidancefor content & format for productcategories
Issue guidancefor content & format for productcategories
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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
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CTD BLACTD BLA
BLA ContentReq’ments• “CMC” guidance• “CMC” guidance• “CMC” guidance
BLA ContentReq’ments• “CMC” guidance• “CMC” guidance• “CMC” guidance
Formatting of BLA to CTD ConstructFormatting of BLA to CTD Construct
Revise guidancefor new format
Revise guidancefor new format
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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
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CBER’s CTD Implementation Process
Revise “CMC” guidances to map CTD to BLA
“Specified Products” currently in process
Staff training Workshops likely
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Integration of CTD with Applications for Product Approval