Part B
Formal Requirements of the European Application Dossier and Practical Aspects
    • B 1 Marketing Authorisation Application - Legal Requirements and General Aspects
      • B 1.1 EU Pharmaceutical Legislation - EudraLex
        • B 1.1.1 Legally Binding Pharmaceutical Legislation and Soft Law
        • B 1.1.2 Notice to Applicants for Medicinal Products for Human Use
        • B 1.1.3 Scientific Guidelines Related to Quality, Safety and Efficacy
      • B 1.2 Marketing Authorisation
        • B 1.2.1 Validity and Cessation of a Marketing Authorisation
      • B 1.3 Marketing Authorisation Procedures and Community Referrals
      • B 1.4 Application Types
      • B 1.5 Application for a Marketing Authorisation - CTD Format
    • B 2 General Information about the Common Technical Document (CTD)
      • B 2.1 General Aspects of the Harmonised Common Technical Document (CTD)
      • B 2.2 International Development and Harmonisation of Dossier Format - Historical Milestones
      • B 2.3 Activities of ICH
      • B 2.4 Format and Structure of the CTD
      • B 2.5 Advantages of the CTD
      • B 2.6 Implementation of the ICH-CTD Document in Europe
      • B 2.7 Correlation Table EU-CTD versus EU Dossier (1998)
    • B 3 Administrative and Prescribing Information (Module 1 EU-CTD)
      • B 3.1 Module 1 CTD - General Information
        • B 3.1.1 Languages to be Used and Number of Copies of the Dossier
        • B 3.1.2 Delivery Addresses for Dossiers and Correspondence
        • B 3.1.3 Official Journals of EU Member States, the EMA and the EFTA Member States
      • B 3.2 Table of Contents and Requirements for the Regional Administrative Information in Module 1 CTD
      • B 3.3 How to Fill in the Application Form
    • B 4 Common Technical Document Summaries (Module 2 EU-CTD)
      • B 4.1 Module 2 CTD - Common Technical Document Summaries - General Aspects
        • B 4.1.1 Table of Contents
        • B 4.1.2 Module 2 Introduction
        • B 4.1.3 Quality Overall Summary (QOS)
        • B 4.1.4 Non-clinical Overview
        • B 4.1.5 Clinical Overview
        • B 4.1.6 Non-clinical Summary
        • B 4.1.7 Clinical Summaries
    • B 5 Quality of Drug Substance and Drug Product (Module 3 EU-CTD)
      • B 5.1 Necessary Data to be Presented by the Applicant in Module 3 CTD
      • B 5.2 Quality of Drug Substance
        • B 5.2.1 Requirements of CTD Module 3.2 S - Drug Substance
        • B 5.2.2 European Certificate of Suitability to the Monograph of the European Pharmacopoeia (CEP)
        • B 5.2.3 Active Substance Master File (ASMF)
        • B 5.2.4 Certificate of Suitability to the Monographs of the European Pharmacopoeia (CEP) or Active Substance Master File (ASMF) - A Comparison
      • B 5.3 Quality of Drug Product - Requirements of CTD Module 3.2.P
      • B 5.4 List of EU Legislation
      • B 5.5 Compilation of a Quality Dossier - What has to be Considered*
        • B 5.5.1 Definition of a Quality Document
        • B 5.5.2 Document Pagination and Segregation
        • B 5.5.3 Table of Contents and Formatting
        • B 5.5.4 When can Separate or Repeated Sections be Appropriate?
        • B 5.5.5 Multiple Containers and Multiple Strenghts
        • B 5.5.6 Bioanalytical Methods
        • B 5.5.7 Multiple Links between Different Sections
        • B 5.5.8 Checklist for CTD-Module 3
        • B 5.5.9 Evaluation of Chemical, Pharmaceutical and Biological Documentation for Chemical Active Substance(s) and Biological Medicinal Products*
      • B 5.6 Frequently Observed Deficiencies
    • B 6 Non-Clinical Study Reports (Module 4 EU-CTD)
      • B 6.1 Non-clinical Study Reports - General Aspects
        • B 6.1.1 Basic Principles and Requirements
        • B 6.1.2 Requirements for and Organisation of "Non-clincial Studies" According to Module 4 CTD
      • B 6.2 Different Kinds of Non-clinical Study Reports (CTD Section 4.2) - General Aspects
        • B 6.2.1 Pharmacology
        • B 6.2.2 Pharmacokinetics
        • B 6.2.3 Toxicology
          • B 6.2.3.1 Single Dose Toxicology
          • B 6.2.3.2 Repeat-Dose Toxicology
          • B 6.2.3.3 Genotoxicity
          • B 6.2.3.4 Carcinogenicity
          • B 6.2.3.5 Reproductive and Developmental Toxicity
          • B 6.2.3.6 Local Tolerance
          • B 6.2.3.7 Other Toxicity Studies
      • B 6.3 List of References for Non-Clinical Guidelines
    • B 7 Clinical Study Reports (Module 5 EU-CTD)
      • B 7.1 Clinical Study Reports - General Aspects and GCP Requirements
        • B 7.1.1 Phases of Clinical Development (Phase I-IV) - An Overview
          • B 7.1.1.1 Clinical Trials Phase I
          • B 7.1.1.2 Clinical Trials Phase II
          • B 7.1.1.3 Clinical Trials Phase III
          • B 7.1.1.4 Clinical Trials Phase IV
      • B 7.2 Prerequisites for Conducting Clinical Studies
        • B 7.2.1 Request for an Authorisation of a Clinical Trial
      • B 7.3 Dossier Requirements for Clinical Trials - General Aspects
        • B 7.3.1 Compilation of a Single Core Clinical Study Report Acceptable to all Regulatory Authorities of the ICH Regions
          • B 7.3.1.1 General Requirements for the Study Protocol
        • B 7.3.2 Requirements for an Organisation of Clinical Study Reports According to Module 5 CTD
        • B 7.3.3 Different Kinds of Clinical Study Reports (CTD Section 5.3) - General Aspects
          • B 7.3.3.1 Reports on Biopharmaceutic Studies (Bioavailability and Bioequivalence)
            • B 7.3.3.1.1 Bioavailability (BA) Study Reports
            • B 7.3.3.1.2 Comparative Bioavailability (BA) and Bioequivalence (BE) Study Reports
              • B 7.3.3.1.2.1 Particularities for Modified Release Products
              • B 7.3.3.1.2.2 Proving Bioequivalence for Several Strengths of a Dosage Form
              • B 7.3.3.1.2.3 ‘Biowaiver’
            • B 7.3.3.1.3 In vitro-In vivo Correlation Study Reports
            • B 7.3.3.1.4 Reports of Bioanalytical and Analytical Methods for Human Studies
            • B 7.3.3.1.5 Frequently asked Questions and Deficiencies in Biopharmaceutical Study Reports
          • B 7.3.3.2 Reports of Human Pharmacokinetic (PK) Studies
          • B 7.3.3.3 Reports on Human Pharmacodynamic (PD) Studies
          • B 7.3.3.4 Efficacy and Safety Studies
          • B 7.3.3.5 Reports of Post-Marketing Experience
          • B 7.3.3.6 Case Report Forms and individual Patient Listings
          • B 7.3.3.7 Literature References in Module 5 CTD
        • B 7.3.4 Pharmacovigilance
      • B 7.4 Other Useful Information
        • B 7.4.1 List of References to Clinical Studies
        • B 7.4.2 Requirements for Clinical Studies - Checklist
        • B 7.4.3 Classification of Medicinal Products with Examples
    • B 8 Variations to the Terms of a Marketing Authorisation
      • B 8.1 Classification of Variations
        • B 8.1.1 Minor Variation of Type IA and IB
        • B 8.1.2 Major Variation of Type II
        • B 8.1.3 Extension Applications
        • B 8.1.4 Urgent Safety Restrictions
      • B 8.2 Grouping of Variations
      • B 8.3 Worksharing Procedure
      • B 8.4 Application Form for a Variation to a Marketing Authorisation
      • B 8.5 Variations - Guidelines and References
    • B 9 Regulatory Compliance
      • B 9.1 Practical Aspects of Regulatory Compliance
    • B 10 Investigational Medicinal Product Dossier (IMPD)
      • B 10.1 Commencement of Clinical Trials
        • B 10.1.1 Requesting a Clinical Trial Authorisation (CTA)
        • B 10.1.2 Requesting an Opinion of the Ethics Committee
        • B 10.1.3 Notification of Amendments
        • B 10.1.4 Declaration of the End of the Clinical Trial
      • B 10.2 Investigational Medicinal Product (IMP) Related Data
        • B 10.2.1 Investigational Medicinal Product Dossier (IMPD)
          • B 10.2.1.1 Quality Data - Structure and Content of the Chemical and Pharmaceutical Quality Documentation
            • B 10.2.1.1.1 Changes to IMP Quality Data
          • B 10.2.1.2 Non-clinical Pharmacology and Toxicology Data
          • B 10.2.1.3 Previous Clinical Data (including Overall Risk and Benefit Assessment)
        • B 10.2.2 Simplified Investigational Medicinal Product Dossier (IMPD)
        • B 10.2.3 Comparator and Placebo Preparations
      • B 10.3 GMP Requirements for Investigational Medicinal Products (IMP) and Active Pharmaceutical Ingredients (APIs) for Use in Clinical Trials
    • B 11 Special Considerations for Marketing Authorisation Applications in Switzerland
      • B 11.1 Marketing Authorisation Application in Switzerland
        • B 11.1.1 Procedures for Marketing Authorisation Application in Switzerland
        • B 11.1.2 Chronology of the Authorisation Procedure
      • B 11.2 Regional Part of the Marketing Authorisation Application Submitted to Swissmedic
      • B 11.3 Handling Variations in Switzerland
        • B 11.3.1 Notifications
        • B 11.3.2 Approvable Variations
        • B 11.3.3 Essential Changes Resulting in a New Licence
    • B 12 GxP
      • B 12.1 Good Regulatory Practices (GRP)
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