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B Y
T A N M A Y P A N I G R A H Y
M . P H A R M
R I P S , B E R H A M P U R
REGULATORY REQIREMENTS
FOR APPROVAL OF BIOLOGICS
FOR BIOLOGICS
CDSCO
DBT
RCGM
ROLE OF CDSCO, DBT & RCGM
 CDSCO:- Safety & Effectiveness of of the Drug in the
Country
 DBT & RCGM:- Accountable for the Pre-Clinical
Evaluation of Recombinant Biologics.
APPLICABLE REGULATIONS & GUIDELINES
 1. Drugs & Cosmetic Act-1945
 2. Recombinant DNA Safety Guideline-1990
 3. CDSCO Guidance for Industry-2008
COMPETENT AUTHORITY & SCOPE
 1. RCGM
 2. GEAC
 3. CDSC
 4. Used to the well determined Proteins with their
Function substances existed in DNA recombinanat
Technology
PRINCIPLE INVOLVED IN SIMILAR
BIOLOGICS
 1. Selection of Reference Biologics
 2.Manufacturing Process
Molecular Biologics Consideration
Fermentation Process Development
Downstream Process Development
3. Quality Based Consideration
 Analytical Methods
 Product Characterization
DATA REQUIREMENTS FOR PRE-CLINICAL
STUDIES
 Toxicological Studies
 Information of ADME
 Mechanism of Action
 Available Toxic Data
 Pharmacodynamic Studies
IV-IV Tests
Toxicological Studies
Immune Responses
DATA REQUIREMENTS FOR CLINICAL TRIAL
APPLICATION
 Half Life
 Pharmacokinetics Parameters
 Route of Administrations
 Indications
 Design Consideration
MARKET AUTHORIZATION APPLICATION
 Phase-III Clinical Trial Report & Protocol is
Mandatory
 Must follow CDSCO Guidance Documents
POST MARKET DATA FOR BIOLOGICS
 Pharmacovigilance Plan ( Submit PSURs)
 ADR Reporting ( Serious Adverse events should be
Reported with in 15 days as per Scheduled Y)
 Post Marketing Studies
REGULATORY REQIREMENTS FOR  APPROVAL OF BIOLOGICS.pptx

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REGULATORY REQIREMENTS FOR APPROVAL OF BIOLOGICS.pptx

  • 1. B Y T A N M A Y P A N I G R A H Y M . P H A R M R I P S , B E R H A M P U R REGULATORY REQIREMENTS FOR APPROVAL OF BIOLOGICS
  • 3. ROLE OF CDSCO, DBT & RCGM  CDSCO:- Safety & Effectiveness of of the Drug in the Country  DBT & RCGM:- Accountable for the Pre-Clinical Evaluation of Recombinant Biologics.
  • 4. APPLICABLE REGULATIONS & GUIDELINES  1. Drugs & Cosmetic Act-1945  2. Recombinant DNA Safety Guideline-1990  3. CDSCO Guidance for Industry-2008
  • 5. COMPETENT AUTHORITY & SCOPE  1. RCGM  2. GEAC  3. CDSC  4. Used to the well determined Proteins with their Function substances existed in DNA recombinanat Technology
  • 6. PRINCIPLE INVOLVED IN SIMILAR BIOLOGICS  1. Selection of Reference Biologics  2.Manufacturing Process Molecular Biologics Consideration Fermentation Process Development Downstream Process Development 3. Quality Based Consideration  Analytical Methods  Product Characterization
  • 7. DATA REQUIREMENTS FOR PRE-CLINICAL STUDIES  Toxicological Studies  Information of ADME  Mechanism of Action  Available Toxic Data  Pharmacodynamic Studies IV-IV Tests Toxicological Studies Immune Responses
  • 8. DATA REQUIREMENTS FOR CLINICAL TRIAL APPLICATION  Half Life  Pharmacokinetics Parameters  Route of Administrations  Indications  Design Consideration
  • 9. MARKET AUTHORIZATION APPLICATION  Phase-III Clinical Trial Report & Protocol is Mandatory  Must follow CDSCO Guidance Documents
  • 10. POST MARKET DATA FOR BIOLOGICS  Pharmacovigilance Plan ( Submit PSURs)  ADR Reporting ( Serious Adverse events should be Reported with in 15 days as per Scheduled Y)  Post Marketing Studies