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Drug Development and Regulatory Affairs

Jul 8, 2024

Drug Development and Regulatory Affairs

Introduction

  • Lecturer: Sachin Gakkad
  • Qualifications:
    • Master of Pharmacy in Pharmaceutical Quality Assurance
    • Postgraduation Diploma in Pharmaceutical Regulatory Affairs
    • From Delhi

Course Overview

  • Main Topics to Be Covered:
    • Drug Development Approval Process
    • Regulatory Affairs
    • Roles and Responsibilities of Regulatory Affairs Professionals
    • Regulatory Authorities of Different Countries
    • Orange Book, ICH, 180 Day Exclusivity
    • Basic Terminologies: Generic Drug Product, IND, NDA, ANDA
    • Potential U.S. Regulatory Pathways
    • DMF and its Types
    • Types of NDA Filing
    • CTD and Its Modules
    • Marketing Authorization Application
    • Marketing Authorization Procedure in Europe
    • Difference Between NDA and ANDA

Drug Development and Approval Process

  1. Basic Research & Target Discovery
    • Identify target for drug development
  2. Drug Discovery
  3. Pre-Clinical Testing
    • Conduct animal studies
  4. IND Application (Investigational New Drug)
    • Submitted to FDA
    • If approved, clinical trials can be conducted
  5. Clinical Trials (Phases 1-4)
    • Phase 1: Healthy volunteers, side effects and dosage
    • Phase 2: 100-200 patients, efficacy
    • Phase 3: Large population, long-term efficacy
    • Phase 4: Post-marketing, safety, and efficacy
  6. NDA Submission (New Drug Application)
    • Reviewed by FDA
    • If approved, drug can be manufactured and marketed

Regulatory Affairs

  • Definition: Interface between pharmaceutical industry and drug regulatory authorities
  • Roles & Responsibilities:
    • Adherence to guidelines (ICH, cGMP, GLP, GCP)
    • Prepare and compile IND, NDA, ANDA, MAA, DMF
    • Lifecycle management, post-marketing variations

Regulatory Authorities by Country

  • USA: FDA (Food and Drug Administration)
  • UK: MHRA (Medicines and Healthcare product Regulatory Agency)
  • Europe: EMEA (European Medicines Evaluation Agency)
  • Australia: TGA (Therapeutic Goods Administration)
  • Brazil: ANVISA
  • China: SFDA (State Food and Drug Administration)
  • Japan: MHLW (Ministry of Health, Labor, and Welfare)

IND (Investigational New Drug)

  • Get approval for human clinical trials
  • Types of INDs:
    • Investigator IND: Submitted by a physician
    • Treatment IND: For serious or life-threatening conditions
    • Emergency Use IND: Filed during emergencies

NDA (New Drug Application)

  • For marketing a new pharmaceutical product in the USA
  • Includes animal studies and human clinical trials
  • Generic Drug Product: Comparable to innovator drug product
    • Same dosage form, administration route, quality, strength, performance, and intended use

Potential U.S. Regulatory Pathways

  • 505(j) ANDA: For generic products
  • 505(b)(1) NDA: Full application
  • 505(b)(2) NDA: Hybrid between full and generic applications

Drug Master File (DMF)

  • Provides confidentially detailed info to FDA
  • Types:
    • Type 1: Manufacturing site, facilities, personnel
    • Type 2: Drug substance, intermediates
    • Type 3: Packaging materials
    • Type 4: Excipients, flavorants
    • Type 5: Reference info, discouraged by FDA

ICH

  • Full form: International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use
  • Guidelines Types: Quality, Safety, Efficacy, Multidisciplinary
  • Orange Book: List of approved drug products with therapeutic equivalence evaluations

180-Day ANDA Exclusivity

  • First to file ANDA with Para IV certification gets exclusivity

Types of NDA Filing

  • Para 1: No listed patent
  • Para 2: Patent expired
  • Para 3: Patent will expire on a particular date
  • Para 4: Patent is invalid

CTD (Common Technical Document)

  • Modules:
    • Module 1: Regional admin info
    • Module 2: CTD Table of contents, summaries
    • Module 3: Quality
    • Module 4: Non-clinical study reports
    • Module 5: Clinical study reports

Marketing Authorization Application (MAA)

  • Application for bringing a developed pharmaceutical product to market in Europe

Marketing Authorization Procedure in Europe

  • Steps:
    1. File MAA
    2. Validation by RMS (Reference Member State)
    3. Distributed to CMS (Concern Member State)
    4. CMS validation
    5. Marketing authorization given to applicants
  • Approval Procedures:
    • National, Mutual Recognition, Decentralized, Centralized

Difference Between NDA and ANDA

  • NDA: New Drug Application
    • For new drug
    • Longer time (12-15 years)
    • Higher cost
    • Non-clinical & clinical studies required
  • ANDA: Abbreviated New Drug Application
    • For generic drug
    • Shorter time (1-2 years)
    • Lower cost
    • Bioavailability or bioequivalence studies required

Conclusion

  • Encouraged to like, share, and subscribe to the channel

Full transcript