Pharma Market Authorization Strategies: A guide to launching drugs quickly and efficiently in Europe

Pharma Market Authorization Strategies: A guide to launching drugs quickly and efficiently in Europe is a practical guide to speeding the process of launching drugs in the European market, deciding where to market first and how to build and retain market share post-authorization.

Launching a drug in Europe can be an extremely costly and time-consuming procedure, although the centralized procedure is gaining ground as the one-stop shop for a EU-wide marketing authorization, its use is restricted to NCEs and biotechnology products. The majority of marketing authorizations are still issued by national competent authorities through the mutual recognition procedure.

Pharma Market Authorization Strategies: A guide to launching drugs quickly and efficiently in Europe is a practical guide to speeding the process of launching drugs in the European market, deciding where to market first and how to build and retain market share post-authorization.

This report analyzes current trends and investigates future perspectives predicted by key decision makers.

Guiding the reader through the European Medicines Evaluation Agency's centralized procedure, the report combines insider opinions and the latest data to identify which Reference Member States are the fastest, cheapest and most efficient for NCEs and generics.

For a complete index of this report click on http://www.researchandmarkets.com/reports/28367

Report Index: Table of Contents

PHARMA MARKET AUTHORISATION STRATEGIES

A guide to launching drugs quickly and efficiently in Europe

Executive Summary 12
EU Regulation, an Overview 12
Authorisation in the Centralised Procedure 13
The Mutual Recognition Procedure 14
National Competent Authorities 15
Streamlining Data Submission 16

Chapter 1 EU Regulation, an Overview 18

Summary 18
A History of European Regulation 18
The Multi-state and Concertation procedures 19
The Formation of the EMEA and the MRP 20
Legislative documentation 21

Chapter 2 Authorisation in the Centralised

Procedure 26
Summary 26
Introduction 27
A Network of Agencies 27
The Structure of the EMEA 28
The Committee for Proprietary Medicinal Products 29
The Committee for Veterinary Medicinal Products 31
The Committee for Orphan Medicinal Products 31
Preparing for Personalised Medicines 32
Balancing the budget 33
FDA collaboration 33

Chapter 3 A View From the Director's Chair 36

Summary 36
Introduction 37
Harmonisation of SmPCs 37
The Balance of European Resources 38
Future Role of National Agencies 40
The European Network of Pharmacovigilance 41
Orphan Drugs Budget Shortfall 42
Market Exclusivity 43
Preparing for Gene Therapies 45
A European FDA? 46

Chapter 4 The Mutual Recognition

Procedure 48
Summary 48
Introduction 49
Why use the MRP? 50
Advantages over the centralised procedure 50
Which RMS? 51
The impact of generic prescribing policies and data exclusivity 53
EMEA versus MRP 54
A time/cost analysis 54

Chapter 5 National Competent Authorities 58

Summary 58
Introduction 59
Germany - BfArM 59
Contacts 61
France - AFSSAPS 61
Contacts 65
Italy - Pharmaceuticals Directorate 66
2003 Finance Bill 68
Contacts 69
United Kingdom - MCA 70
Contacts 73
Spain - AEM 73
Contacts 74
The Netherlands - CBG-MEB 75
Contacts 76
Belgium - AFGIP 76
Contacts 78
Sweden - MPA/LIF 79
Contacts 82
Switzerland - Swissmedic 83
Contact 84
Portugal - Infarmed 85
Contacts 86
Austria - BMSG 87
Contacts 87
Greece - EOF 88
Contact 89
Finland - NAM 89
Contacts 91
Denmark - DKMA 91
Contacts 93
Norway - NMA 93
Contacts 95
Ireland - IMB 96
Contact 99
Chapter 6 Streamlining Data Submission 102
Introduction 102
The Common Technical Document 103
Module 1 103
Module 2 103
Module 3 105
Modules 4 and 5 105
The Electronic Common Technical Document 105
Solutions providers case studies 107
Liquent (www.liquent.com) 107
Interview with Philip Hall, Head of Regulatory Affairs at Liquent Europe 108
CDC Solutions (www.cdcsolutions.com) 111
Case Study: Boehringer Ingelheim's eSubmission to EMEA for
Spiriva using CDC's EZsubs 2.03 111
REUTERS BUSINESS INSIGHT
HEALTHCARE
Chapter 7 Appendix 114
The European Healthcare Market 114
Introduction 114
The European Market as a Whole 114
Facts and figures, country by country 115
Germany 115
France 116
Italy 116
United Kingdom 117
Spain 118
The Netherlands 118
Belgium 119
Sweden 119
Switzerland 120
Portugal 120
Austria 121
Greece 121
Finland 122
Denmark 122
Norway 123
Ireland 123
Comparative analysis 124
Glossary of abbreviations and acronyms 127
Index 131

List of Figures

Figure 1.1: Timeline of EU pharmaceutical directives, 1965-1992 22
Figure 1.2: Timeline of EU pharmaceutical regulations, 1993-1996 23
Figure 2.3: (Co-)Rapporteurship to the CPMP, Jan 2001-Sep 2002 29
Figure 2.4: MAAs to the CPMP, Jan 1995-Sep 2002 30
Figure 3.5: Rising EMEA applications for orphan designation, 2000-2002 42
Figure 4.6: Number of times countries acted as RMS in 2001 52
Figure 4.7: Time taken to process EMEA applications, 1995-2002 55
Figure 5.8: France in the MRP, 1997-2000 64
Figure 5.9: Breakdown of Italian MAs, 1998-2002 68
Figure 5.10: Market Authorisations in Sweden, 1998-2002 80
Figure 5.11: Breakdown of Swedish MRPs, 1998-2002 81
Figure 5.12: Comparison of Generic and non-generic authorisations in Portugal, 1998-2001 85
Figure 5.13: Breakdown of Finnish MRPs and National Procedures, 1998-2001 90
Figure 5.14: Time taken to process MAAs in Finland, 1999-2001 90
Figure 5.15: Norwegian Market Authorisation growth, 1998-2001 94
Figure 5.16: MRP increase in Norway, 2000-2001 95
Figure 5.17: IMB product authorisations, 1999-2001 98
Figure 6.18: Screenshot of the file structure of Module 2 of the eCTD 106
Figure 7.19: Comparative health expenditure as % of GDP in European countries studied 124
Figure 7.20: Analysis of health indicators in European countries studied 125

List of Tables

Table 1.1: The rules governing medicinal products in the European Community 23
Table 2.2: CPMP activity, Jan 1995-end 2002 30
Table 2.3: COMP activity, Jan 1995-end 2002 32
Table 2.4: EMEA application fees 34
Table 4.5: MRPs, Jan 1995-end 2002 54
Table 5.6: Authorisations granted by the BfArM, 1998-2002 60
Table 5.7: Time taken to authorise drugs in Germany, 2002 61
Table 5.8: French national procedures, 1997-2000 62
Table 5.9: French Mutual Recognition Procedures, 1997-2000 63
Table 5.10: AFSSAPS and the centralised procedure, 1997-2000 64
Table 5.11: Authorisation fees in France 65
Table 5.12: Authorisations granted in Italy, 1998-2002 67
Table 5.13: Analysis of Italian MAs 1998-2002 67
Table 5.14: Authorisation fees in Italy 69
Table 5.15: Clinical trials dossiers received at the MCA, 1998-2002 70
Table 5.16: Market authorisations granted by the MCA, 1998-2002 71
Table 5.17: Market authorisations granted by the MCA, 1998-2002 71
Table 5.18: Authorisation fees in the UK 72
Table 5.19: Authorisations granted by the MEB, 1998-2001 75
Table 5.20: Authorisation fees in the Netherlands 75
Table 5.21: Belgian national authorisations, 1998-2001 77
Table 5.22: Authorisation fees in Belgium 78
Table 5.23: Market Authorisations in Sweden, 1998-2002 79
Table 5.24: Authorisation fees in Sweden 81
Table 5.25: Portuguese authorisations, 1998-2001 85
Table 5.26: Authorisation fees in Portugal 86
Table 5.27: Authorisation fees in Austria 87
Table 5.28: Authorisation fees in Greece 88
Table 5.29: Authorisation fees in Finland 91
Table 5.30: DKMA's ranking within the EU, 2000-2001 92
Table 5.31: Authorisation fees in Denmark 92
Table 5.32: Norwegian National and Mutual Market Authorisations, 1998-2001 93
Table 5.33: Authorisation fees in Norway 95
Table 5.34: Authorisation fees in Ireland 98
Table 6.35: Regional eSubmission contacts 107
Table 7.36: European pharma market and demography 115
Table 7.37: Germany: pharma market and demography 116
Table 7.38: France: pharma market and demography 116
Table 7.39: Italy: pharma market and demography 117
Table 7.40: The UK: pharma market and demography 117
Table 7.41: Spain: pharma market and demography 118
Table 7.42: The Netherlands: pharma market and demography 118
Table 7.43: Belgium: pharma market and demography 119
Table 7.44: Sweden: pharma market and demography 119
Table 7.45: Switzerland: pharma market and demography 120
Table 7.46: Portugal: pharma market and demography 120
Table 7.47: Austria: pharma market and demography 121
Table 7.48: Greece: pharma market and demography 121
Table 7.49: Finland: pharma market and demography 122
Table 7.50: Denmark: pharma market and demography 122
Table 7.51: Norway: pharma market and demography 123
Table 7.52: Ireland: pharma market and demography 123

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REPORT DATA SUMMARY:
Pharma Market Authorization Strategies: A guide to launching drugs quickly and efficiently in Europe
Publisher Name: Reuters Business Insight
Date Published: 2/1/03
Number of Pages: 133
Category: Healthcare & Medical Devices
URL: www.researchandmarkets.com/reports/28367