REGULATORY REQIREMENTS FOR APPROVAL OF BIOLOGICS

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

2. FOR BIOLOGICS
CDSCO
DBT
RCGM

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