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Regulation & Policy

Pharmaceutical Regulatory Affairs in The Eu & US


Publication Date   January 2006
Publisher   Scrip Reports
Product Type   Report
Pages   not applicable
ISBN Number   not applicable
Product Code   SCR019
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Price £1,095.00

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Summary


Patent expiries, tightening healthcare budgets and a stricter regulatory climate in the aftermath of the Vioxx withdrawal presented major challenges to the pharmaceutical industry in 2006. These tougher operating conditions may partly explain why companies that are less reliant on pharmaceuticals seem to have performed so well last year. Johnson & Johnson, which only has 43% of its revenue coming from pharmaceuticals, for example, toppled Pfizer from its position at the top of the total revenue table for 2006.

The tough operating conditions can also be seen reflected in the general wave of industry restructuring among generics and speciality pharma companies. Among the generics players, consolidation changed the landscape quite dramatically last year with Watson Pharmaceuticals acquiring Andrx to become the third largest player in the US market, Barr Pharmaceuticals (formerly known as Barr Laboratories) acquiring the Croatian firm Pliva, and a number of smaller acquisitions by Indian companies, Dr Reddy's and Ranbaxy Laboratories.

A similar story can be seen in Europe. In Germany, for example, Bayer beat Merck KGaA to acquire Schering AG. Merck KGaA, meanwhile, went on to absorb Europe's largest biotech company, Serono, into its business. Other European deals included Danish Nycomed's surprise acquisition of Altana Pharma at the very end of the year, and the purchase by Belgium's UCB of Schwarz Pharma.

Biotech companies also saw considerable movement with, among other deals, Crucell acquiring Berna Biotech for $476 million and Genzyme acquiring Anormed for $584 million.

Mergers among the top players are rare these days, if only because there are so few potential partners. There was one major acquisition in 2006 (when Schering AG became part of Bayer) although in Japan, traditionally so averse to mergers, Dainippon Sumitomo Pharma was created from Dainippon Pharmaceutical and Sumitomo Pharmaceuticals at the very end of 2005.

A fair number of interesting smaller companies were bought by the larger players in a bid to replenish their pipelines. Last year saw Pfizer buy Powdermed and Rinat Neuroscience, for example. Merck & Co acquired Abmaxis, Glycofi and Sirna Therapeutics; Astrazeneca bought Cambridge Antibody Technology; Novartis bought Neutec Pharma; Abbott Laboratories acquired Kos Pharmaceuticals, and Lilly extended its long-standing research partnership with Icos by bringing it into the fold.

Content


  • Chapter 1 Introduction and Eu Overview
    • 1.1 Origins and Purposes of Regulation
    • 1.1.1 Early British Regulation
    • 1.1.2 Modern Regulation
    • 1.1.3 Development of US Regulations
    • 1.2 Basic Elements and Approaches in Regulation
    • 1.2.1 Safety
    • 1.2.2 Quality
    • 1.2.3 Efficacy
    • 1.2.4 Promotion
    • 1.3 Eu Institutions and Legislation
    • 1.3.1 Paediatric Legislation
    • 1.4 Approaches to Eu Registration
    • 1.4.1 Centralised
    • 1.4.2 Mutual Recognition
    • 1.4.3 Decentralised
    • 1.4.4 National
    • 1.5 Role of The Regulatory Affairs Professional
    • 1.5.1 Interactions within The Company
    • 1.5.2 External Interactions
    • 1.6 Conclusion
  • Chapter 2 US and International Overview
    • 2.1 Introduction
    • 2.1.1 Modern Regulation
    • 2.2 US Fda Regulatory Overview
    • 2.2.1 Investigational New Drug (Ind) Application
    • 2.2.2 New Drug Application (Nda)
    • 2.2.3 Review
    • 2.2.4 Inspection
    • 2.2.5 Approval
    • 2.2.6 Maintenance
    • 2.3 US Administrative Procedure
    • 2.3.1 Emea and Fda Cooperation on Medicines Regulation
    • 2.4 Fda Good Guidance Practices
    • 2.4.1 Guidance Options
    • 2.5 Regulatory Bodies in Other Countries
    • 2.5.1 Tripartite Agreement
    • 2.5.2 Hong Kong
    • 2.5.3 Canada
    • 2.5.4 South (or Latin) America
    • 2.5.5 African Countries
    • 2.5.6 Australia and New Zealand
  • Chapter 3 Product Development
    • 3.1 New Product Development
    • 3.1.1 Steps Involved in Product Development
    • 3.1.2 Attrition Rate for Drugs Selected for Development
    • 3.2 Introduction to The International Conference on Harmonisation (Ich)
    • 3.2.1 How Did Ich Come about?
    • 3.2.2 The Beginnings of Ich
    • 3.3 Pre-Clinical Studies
    • 3.3.1 What Is Toxicity?
    • 3.3.2 Guideline for Toxicity Studies before Clinical Studies (Phase I) in Healthy Volunteers:
    • 3.3.3 Reproductive Toxicology
    • 3.3.4 Mutagenicity Studies
    • 3.3.5 Conventional Carcinogenicity Studies
    • 3.4 Good Laboratory Practice (Glp)
    • 3.4.1 What Is Glp?
    • 3.5 Clinical Trials and Good Clinical Practice
    • 3.5.1 So What Is A Clinical Trial?
    • 3.5.2 Post-Marketing Surveillance (Pms) Studies
    • 3.5.3 What Is Good Clinical Practice?
    • 3.6 Eu Clinical Trials Directive
    • 3.6.1 Clinical Trials Directive (2001/20/Ec)
    • 3.6.2 What Regulatory Documentation Is Required for A Clinical Trial Application in The Eu?
    • 3.6.3 Regulatory Documents Required for A Clinical Trial Application in Eu Member States
    • 3.7 Eu Privacy Legislation
    • 3.8 Fda Clinical Trials Regulation
    • 3.8.1 Organisation
  • Chapter 4 Applications for Marketing Authorisations: General Approach
    • 4.1 Ich Common Technical Document
    • 4.1.1 Introduction
    • 4.1.2 The Ctd
    • 4.1.3 High-Level Structure of Module 1 and The Ctd Modules 2, 3, 4 &
    • 4.1.4 Presentation of The Application
    • 4.2 Eu and US: Similarities and Differences
    • 4.3 Quality (Cmc)
    • 4.4 Safety
    • 4.4.1 Module 2: Overview and Summaries
    • 4.4.2 Guidance Notes
    • 4.5 Efficacy
    • 4.5.1 The Clinical Overview
    • 4.5.2 Structure of Module
    • 4.6 Product Maintenance
    • 4.6.1 Variations
    • 4.6.2 Renewals
    • 4.6.3 Withdrawals
    • 4.7 Other Considerations
  • Chapter 5 Regulation of Generics and Innovator Rights
    • 5.1 Generic Medicines
    • 5.1.1 What Is A Generic?
    • 5.1.2 Pricing of Generics
    • 5.1.3 Licensing A Generic Product
    • 5.2 Intellectual Property Law
    • 5.2.1 Patent Protection
    • 5.2.2 Patent Expiration
    • 5.2.3 Patent Challenge
    • 5.2.4 Data Exclusivity
    • 5.2.5 The Bolar Clause in The Eu
    • 5.2.6 The US 180-Day Generic Drug Product Exclusivity
    • 5.2.7 Data Protection
    • 5.2.8 Other Types of IP Protection
    • 5.3 Supplementary Protection Certificates
    • 5.3.1 What Is An Spc?
    • 5.3.2 The Need for Spcs in The Eu
    • 5.3.3 Obtaining and Maintaining Spcs
    • 5.4 US Patent Term Restoration
    • 5.4.1 Length of Patent Term Restoration
    • 5.4.2 Applying for A Patent Extension
    • 5.4.3 Determining The Length of The Patent Extension
    • 5.5 Parallel Trade Issues
    • 5.5.1 Parallel Trade in The Eu
    • 5.5.2 Parallel Trade in The US
    • 5.5.3 Counterfeiting of Medicinal Products
    • 5.5.4 Products Traded over The Internet
  • Chapter 6 over-The-Counter Drugs, Herbals & Homoeopathics
    • 6.1 over-The-Counter Drugs
    • 6.1.1 Introduction
    • 6.1.2 What Is An Otc Drug?
    • 6.1.3 The '2001 Review'
    • 6.1.4 Advertising and Branding
    • 6.1.5 Safety Assessment for Pom to P Switches
    • 6.1.6 What Is Involved in The Reclassification of Medicines from Pom to P?
    • 6.1.7 Switching from Pom to P
    • 6.1.8 Other Considerations
    • 6.1.9 Data Requirements
    • 6.1.10 Product Information
    • 6.1.11 Other
    • 6.1.12 US Otc
    • 6.1.13 Drug Interactions
    • 6.2 Herbal Medicines
    • 6.2.1 Eu Legislation
    • 6.2.2 Why Is There A Change in The Legislation with Respect to Herbal Medicines?
    • 6.2.3 An Example of An Eu Herbal Medicines Registration Scheme: Mhra
    • 6.2.4 Product Information: Labelling and The User Package Leaflet
    • 6.2.5 Advertising
    • 6.2.6 Pharmacovigilance
    • 6.2.7 US Legislation
    • 6.3 Homeopathy
    • 6.3.1 What Is Homeopathy?
    • 6.3.2 Homeopathic Preparations
    • 6.3.3 Use of Homeopathy around The World
    • 6.3.4 Homeopathic Legislation in The Eu
    • 6.3.5 Homeopathy in The US
  • Chapter 7 Biologicals, Gene Therapy and Other Special Categories
    • 7.1 Biologicals, Biotechnology and Biosimilars
    • 7.1.1 Biologicals
    • 7.1.2 The History of Biotechnology
    • 7.1.3 Types of Biological Products
    • 7.1.4 Licensing A Biological Product
    • 7.1.5 Biosimilars
    • 7.2 Blood and Blood Products
    • 7.2.1 Introduction to Blood and Blood Products
    • 7.2.2 Eu Blood Legislation
    • 7.2.3 US Blood Legislation
    • 7.2.4 Registering A Blood Product
    • 7.3 Gene Therapy and Cloning
    • 7.3.1 Gene Therapy
    • 7.3.2 Cloning
    • 7.3.3 Regulation of Cloning
    • 7.4 Other Special Categories
    • 7.4.1 Radiopharmaceuticals
    • 7.4.2 Nutraceuticals
  • Chapter 8 Safety, Quality and Regulation
    • 8.1 Labelling of Medicinal Products
    • 8.1.1 Introduction to Labelling
    • 8.1.2 Eu Labelling Requirements
    • 8.1.3 US Labelling Requirements
    • 8.2 Pharmacovigilance
    • 8.2.1 Introduction to Pharmacovigilance
    • 8.2.2 When Does Pharmacovigilance Begin?
    • 8.2.3 What Information Is Collected?
    • 8.2.4 What Happens to The Collected Data?
    • 8.2.5 Changes to An Ma as A Result of Pharmacovigilance
    • 8.2.6 Periodic Safety Update Reports
    • 8.2.7 Content of A Psur
    • 8.2.8 Dear Dr Letters
    • 8.2.9 Reporting of Suspected Adverse Drug Reactions in The Eu
    • 8.2.10 Reporting of Suspected Adverse Drug Reactions in The US
    • 8.2.11 Black Triangle
    • 8.3 Ensuring The Quality of Medicinal Products
    • 8.3.1 Introduction to Quality
    • 8.3.2 Counterfeit Products
    • 8.3.3 Defective Products
  • Chapter 9 Advertising and Marketing Practices
    • 9.1 The Role of The Pharmaceutical Industry in Promotion and Medical Education
    • 9.1.1 Introduction to The Promotion of Medicines
    • 9.1.2 Looking after The Consumer
    • 9.1.3 Defining Promotion
    • 9.1.4 Eu Legal Requirements
    • 9.1.5 Differences and Similarities between Countries and Regions in The Regulation of Advertising/Promotional Material
    • 9.2 Organisations Responsible for Monitoring Promotional Activities around The World
    • 9.2.1 Introduction
    • 9.2.2 Global Organisations
    • 9.2.3 European Organisations
    • 9.2.4 UK Organisations
    • 9.2.5 US Organisations
    • 9.3 Compliance Strategies
    • 9.3.1 Compliance Strategies in The US
    • 9.3.2 California Law
    • 9.3.3 Compliance Strategies in The Eu
  • Chapter 10 Other Eu and US Regulations
    • 10.1 Paediatric Medicines Legislation
    • 10.1.1 The Need for Legislation
    • 10.1.2 Legislation in The Eu
    • 10.1.3 Legislation in The US
    • 10.2 Risk Management
    • 10.2.1 Introduction to Risk Management
    • 10.2.2 Risk Management outside of The Eu
    • 10.3 Regulation of Combination Products
    • 10.3.1 US Approach
    • 10.3.2 Eu Approach
    • 10.4 Medicare and Medicaid
    • 10.4.1 Medicare
    • 10.4.2 Problems Facing Medicare
    • 10.4.3 Medicaid
    • 10.5 Core Competencies of A Rap
    • 10.5.1 Introduction
    • 10.5.2 Key Core Competencies
    • List of Tables
      • Table 1.1 The Changing Options Available to Applicants Intending to Register A Medicinal Product in The Eu
      • Table 2.1 The Scope of Fda Good Guidance Practices
      • Table 3.1 Examples of Product Failure Rates as They Move through Developments
      • Table 3.2 Reasons for Terminating A Product in Development
      • Table 3.3 Chronological Events in The History of Ich
      • Table 3.4 Guidance for Toxicity Studies (Time of Exposure) before Clinical Trials in Patients: Ich M3
      • Table 3.5 Toxicology Data to Support Phase Iii Trials in Eu
      • Table 3.6 The Phases of Clinical Development
      • Table 3.7 Guidance for Patient Privacy Rights
      • Table 4.1 General Differences between The Eu and US Applications
      • Table 4.2 Module 3: Quality
      • Table 4.3 Module 3: Ctd Organisation
      • Table 4.4 General Guidelines
      • Table 4.5 Active Substance Guidelines
      • Table 4.6 Medicinal Product Guidelines
      • Table 4.7 Module 4: Non-Clinical
      • Table 4.8 Relevant Pharmacokinetic Documents
      • Table 4.9 Relevant Toxicology Documents
      • Table 4.10 General Guidelines
      • Table 4.11 General Efficacy Clinical Safety
      • Table 4.12 Clinical Pharmacology
      • Table 5.1 Brufen (Ibuprofen) and Its Associated Generic Versions
      • Table 5.2 Market Protection for An Originator's Theoretical Product in The Eu
      • Table 6.1 Eu Member States and The Implementation of Articles 16(1) or 16(2)127
      • Table 9.1 Type of Regulation and Legal Requirements for Advertising of Medicines
      • Table 10.1 Overview of The Eu Risk Management Plan Template Produced by The Emea
      • Table 10.2 Core Competencies Required by A Rap