CTD Dossier Preparation - PHARMEXCIL

1 CTD Dossier Preparation K. Srikantha Reddy Affairs Medreich Limited CTD Dossier Preparation CTD (Common Technical Document). contains 5 modules Module 1. Module 2. Module 3. Module 4. Module 5. DMF. Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging and storing of one or more human packaging, drugs. The information contained in the DMF. may be used to support following, Investigational New Drug Application (IND), (IND).

2 New Drug Application (NDA), Abbreviated New Drug Application (ANDA), Export Application. ANDA: An Abbreviated New Drug Application (ANDA). is an application for a generic drug approvall for f an existing i ti li licensed d medication di ti or approved drug. The ANDA contains data which when submitted to FDA's Center For drug Evaluation and Research (CDER), Office of Generic Drugs, provides for the review and ultimate approval p pp of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the American public.

3 Module 1 ( EU). Module-1: Administrative Information and Prescribing Information 1 0 Cover Letter Comprehensive Table of Content Application Form 1 3 Product P d t IInformation f ti SPC's, Labelling and Packaging Mock-Up Specimen Consultation with target patient group 1 3 5 SPC. SPC's s already approved in the Member states Braille Module - 1. Information about the Experts Specific p Requirements q for different types of applications Environmental Risk Assessment g to Orphan Information relating p Market Exclusivity Information relating to Pharmacovigilance Information relating to clinical Trials Information relating to Pediatrics Response to Queries Additional Data Module - 2.

4 Module - 2: CTD Summary 2 1 Table T bl off C. Content t t (Comprehensive). (C h i ). Introduction (general introduction to the pharmaceutical, including its pharmacology class, moded off action, ti andd proposed d clinical li i l use)). Quality Overall Summary Non- clinical Overview clinical Overview Non- clinical Written and Tabulated Summaries clinical summary y Module - 2. Non- clinical Overview Ge General e a Aspects spects Content and Structural Format clinical Overview Product Development of Content Rationale Overview of Biopharmaceutics 2 5 3 Overview of clinical Pharmacology Overview of Efficacy Overview of Safety Benefits and Risks Conclusions Literature References Module - 2.

5 Non- clinical Written and Tabulated Summaries Pharmacology 2 6 2 Pharmacokinetics Ph ki ti Toxicology 2 7 clinical summary Biopharmaceutic Studies and Associated Analytical Methods clinical Pharmacology Studies clinical Efficacy 2 7 4 clinical Cli i l S. Safety f t Literature References 2 7 6 Synopses of Individual Studies Module - 3. Module 3: Quality Q y Table of Contents Body y of Data Drug Substance General Information Nomenclature Structure 3 2 S 1 3 General Properties Module - 3. Manufacture Manufacturer Details Description of Manufacturing Process and Process Controls 3 2 S 2 3 Control of Materials Controls of Critical Steps and Intermediates 3 2 S 2 5 Process P Validation V lid ti and d /or / Evaluation E l ti Manufacturing Process Development Characterisation Elucidation of structure and other Characteristics 3 3 Impurities pu Module - 3.

6 Control of Drug Substance Specification of Drug Substance Analytical Procedures Validation of Analytical Procedures Batch Analyses Justification of Specification 3 2 S 5 Reference Standards or Materials Container Closure System Stability Stability Summary and Conclusions Post-approval Stability Protocol and Stability Commitment Stability Data Module - 3. Drug Product Description and Composition of the Drug Product 3 2 P 2 Pharmaceutical Ph ti l D. Development l t Components of Drug Product 3 2 P 2 2 Drug Product Manufacturing Process Development p Container Closure System Microbiological Attributes Compatibility Module - 3.

7 3 2 P 3 Manufacture M f t Manufacturer 3 2 P 3 2 Batch Formula Description of Manufacturing Process and Process Controls Controls of Critical Steps and Intermediates 3 2 P 3 5 Process Validation and /or Evaluation Module - 3. 3 2 P 4 Control of Excipients Specifications 3 2 P 4 2 Analytical Procedures Validation of Analytical Procedures Justification of Specifications 3 2 P 4 5 Excipients of Human or Animal Origin Novel Excipients Module - 3. 32P5 C. Control t l off D. Drug Product P d t Specification of Drug Product 3 2 P 5 2 Analytical Procedures Validation of Analytical Procedures Batch Analyses Characterisation of Impurities p Justification of Specification Reference Standards or Materials Container Closure System Module - 3.

8 Stability Stability Summary and C l i Conclusions Post-approval Stability Protocol and Stability Commitment 3 2 P 8 3 Stability Data Module - 3. Appendices Facilities and Equipment Adventitious Agents Safety Evaluation 3 2 A 3 Novel Excipients Regional Information/ Requirements Process Validation and or Evaluation Medical Device Restricted part of DMF. 3 2 R 4 Medicinal M di i l products d t containing t i i or using i iin the manufacturing process materials of animal and / or human origin. List of Literature References Module - 4.

9 Module - 4: Non- clinical study y Reports p Table of contents study Reports 4 2 1 Pharmacology Primary Pharmacodynamic Secondary Pharmacodynamic 4 2 3 Safety S f t pharmacology h l Pharmacodynamic drug interactions Module - 4. Pharmacokinetics Analytical Methods and validation Reports 4 2 2 2 Absorption Distribution Metabolism Excretion Pharmacokinetic Drug Interactions Other Pharmacokinetic studies Module - 4. Toxicology 4 2 3 1 Single-dose toxicity Repeat-dose toxicity Genotoxicityy Carcinogenicity Reproductive and developmental t i it toxicity Local tolerance 4 2 3 7 Other toxicity studies Literature References Module - 5.

10 M d l - 5: Module 5 clinical Cli i l study St d Reports R t Table of Contents Tabular Listings of All clinical Studies clinical study Reports Bioavailability (BA) study Reports Comparative BA and Bioequivalence study reports In-vitro In-vivo Correlation study reports Reports of Bioanalytical and Analytical methods 5 3 2 1 Plasma Protein Binding study Reports Reports of Hepatic metabolism and Drug Interaction Studies Reports of Studies Using human Biomaterials Module - 5. 5331 H. Healthy lth SSubject bj t PK andd Initial I iti l Tolerability study reports Patient PK and Initial Tolerability y study reports.