Urch Publishing | Publication

Regulatory

Title

Pharmaceutical Regulation in Europe

Sub title

Industry Challenges

Author

P Kanavos

Publication date

May 2000

ISBN

1860674666

Pages

Information currently unavailable

Price

pdf £150 | print n/a

Summary

Pharmaceutical Regulation in Europe provides a thorough analysis of all aspects of pharmaceutical regulation, cutting through complex official documentation to give a clear insight into this complex field. Starting with the very first Community legislation on public health and medicines, the report guides you right through to the current day where the Commission's influence pervades almost every aspect of the pharmaceutical industry.

Using clear language throughout, Pharmaceutical Regulation in Europe delivers straightforward information from a wealth of resources about every facet of regulation. It is mandatory reading for all who need to stay up to date with this changing area.

The EU regulatory framework governing the development, testing, manufacture and marketing of prescription pharmaceuticals within the European Community underwent a significant development on 1 January 1995 with the introduction of the EMEA.

This report provides a comprehensive update of all subsequent developments across the key areas of product registration, patents, advertising, packaging and pharmacovigilance.

Key benefits:

Contains a useful summary of the main EU institutions, legal instruments, ICH process and workings of the EMEA

Summarises procedures and directives currently regulating pharmaceutical production and sales within the EU including product registration, advertising and packaging, patents, good manufacturing, laboratory and clinical practice and pharmocovigilance

Evaluates the strengths and weaknesses of alternative registration procedures

Provides an insight into national variations in marketing restrictions, labelling, packaging and advertising regulations

Calculates how long an NCE product has exclusivity and provides guidance on implementing a profit maximisation scheme

Guidance on the registration of NCE products and an explanation of the GMP, GLP and GCP guidelines

Guidance on effective post-marketing surveillance of an NCE product in accordance with those responsibilities identified by EU regulations

Complemented by a glossary, tables and figures

TABLE OF CONTENTS

Contents

Executive Summary

The basis for pharmaceutical regulation in the EU
Registration of medicinal products
Summary of the new systems
Centralised system
Decentralised system
Other EU legislation
Patents
Packaging
Advertising
Good manufacturing
laboratory and clinical practice
Pharmacovigilance
Towards global harmonisation

1: The EU Regulatory Framework

The evolution of the European Community: from ECSC to EU
EU institutions
The Council of Ministers
The European Commission
The directorates-general
The European Parliament
Legislation
Budget
Supervising the executive
Make-up of the Parliament
The European Court of Justice
The European Council
Major EU legislative instruments
Legally-binding instruments
Regulations
Directives
Decisions
Instruments that are not legally binding
Recommendations and opinions
Notices
Pharmaceutical legislation and documents
The core legislation
The current situation
Registration
Biologicals
Good manufacturing practice
Good laboratory practice
Patents
Pricing
Pharmacovigilance
Advertising
Labelling
Legal status

2: The Main Official Bodies

DG involvement: DG III and others
DG III
Committee on proprietary medicinal products
CPMP role and activities
Rapporteur
The pharmaceutical committee
European Medicines Evaluation Agency
Management board
Membership of the management board
Unit for the evaluation of medicinal products for human use
Etomep (European Technical Office for Medicinal Products)
Committees and external expertise for the EMEA
Telephone directory of delegations
Budget
Evolution of the EMEA staff structure
Fees

3: Registration Procedures For Pharmaceuticals

The first European systems: brief review
Multistate procedure
Effectiveness of the multistate procedure
Concertation procedure
Effectiveness of the concertation procedure
Present systems
The centralised procedure
Part A: medicinal products derived from biotechnology
Part B: innovative medicinal products
Submission of the marketing authorisation application
Languages to be used
Number of copies
Variations
Evaluation of the MAA
and the CPMP opinion
Outcomes to an MAA
The final decision on the MAA
Refusal of an EC marketing authorisation
Granting of an EC marketing authorisation
Status of an EC marketing authorisation
Management of the EC marketing authorisation
Transfer of marketing authorisation
Application for variation to an EC marketing authorisation
Accelerated evaluation process
The mutual recognition (decentralised) procedure
Relations between national authorisations for the same medicinal product
Serial MAAs
Parallel applications
Purely national applications
Mutual recognition of national authorisations
Authorisations likely to be recognised
Mutual recognition of EU generics
Reference member state
Evaluation report
Documentation
Acceptance of recognition
Refusal of recognition
The arbitration procedure
Roles and relationships of EU and national regulatory bodies
Practical aspects and guidance
Protection from the second applicant
National registration procedures
Germany
Post-registration changes
The UK
Post-registration changes
Sweden
Post-registration changes
Other EU countries
Austria
Belgium
Denmark
Finland
France
Greece
Ireland
Italy
The Netherlands
Portugal
Spain
Use of electronic media for registration processes
DAMOS
SEDAMM
MERS
MANSEV

4: The Notice To Applicants And The Dossier

Notice to Applicants
Volume IIA of the NTA
Volume IIB of the NTA: guidance on the application dossier
Dossier overview
Part IA: administrative data
Fees
Declaration and signature
Type of application
Details of product and applicant
Marketing authorisation particulars
Part IB: summary of product characteristics
Part IC: expert reports
Part II: chemical and pharmaceutical documentation
Part III: toxicological and pharmacological documentation
Part IV: clinical documentation

5: Regulatory And Other Aspects Of Biotechnology Products And Biologicals

Biotechnology products
Registration
List A
Other regulations
Contained use of GMMs
Deliberate release of GMOs into the environment
The EC and biotechnology
The Senior Advisory Group on Biotechnology
Commission communication on biotechnology
CPMP biotechnology guidelines
Biological products
Council directive 89/342/EEC
Council directive 89/381/EEC
Problems with contaminated blood
CPMP guidelines on biological products
Bioethics convention

6: Packaging And Advertising

Labels
Small packs
Legibility Leaflets
Areas of concern
Clarity and readability issues
New guidelines on packaging
National rules on packaging and labelling
Austria
Belgium
Denmark
Finland
France
Germany
Greece
Ireland
Italy
The Netherlands
Portugal
Spain
Sweden
The UK
Advertising
Main provisions of the advertising directive
Scope and definitions
Advertising to the general public
Advertising to healthcare professionals
Control of advertising
National regulations on advertising of prescription medicines
Austria
Belgium
Denmark
Finland
France
Germany
Greece
Ireland
Italy
The Netherlands
Portugal
Spain
Sweden
The UK

7: Patent Issues

EC moves to extend patent protection
National patent regulations
Austria
Belgium
Denmark
Finland
France
Germany
Greece
Ireland
Italy
The Netherlands
Portugal
Spain
Sweden
The UK
Protecting and challenging pharmaceutical patents
Biotechnology patents
EC biotechnology directive
Biotechnology inventions: the current position

8: Pharmacovigilance

Role of CPMP
The rapid-alert system
Pharmacovigilance in the Notice to Applicants
Pharmacovigilance since 1 January 1995
National and decentralised procedures
Company responsibilities
Member state responsibilities
Centralised procedures
Pharmacovigilance measures in EU countries
Austria
Belgium
Denmark
Finland
France
Germany
Greece
Ireland
Italy
The Netherlands
Portugal
Spain
Sweden
The UK

9: Good Manufacturing, Laboratory And Clinical Practice

Good manufacturing practice
Guidelines
Directives
Good laboratory practice
87/18/EEC
88/320/EEC
90/18/EEC
Good clinical practice
CPMP guidelines and new GCP directive

10: Towards A Global Consensus In Pharmaceutical Regulation: The ICH Process

ICH1 and its aftermath
ICH2 and after
The five-step harmonisation process
Efficacy
Requirements for testing medicines on geriatric patients
Dose-response information to support drug registration
Extent of population exposure required to assess clinical safety of drugs
Guidance on clinical safety data management
Good clinical practice
Clinical study reports
Safety
Detection of reproductive toxicity of products
Repeat-dose toxicity testing
Issues in the assessment of carcinogenic potential of therapeutic agents
Toxicokinetics
Genotoxicity testing requirements
Quality
Stability testing of new drug substances
Light stability testing
Validation of analytical methods
Quality of biotechnology products
Impurities in new drug substances
Pharmacopoeial monographs and methods
Progress at ICH3
Safety
Efficacy
Quality
Timing of non-clinical studies
Regulatory communications
The significance of ICH

Appendix

EU and national regulatory authorities

Glossary

List of Tables

Table 1.1: Directorates-general of the European Commission
Table 1.2: Rules governing medicinal products in the European Community
Table 2.1: Adopted CPMP guidelines
Table 2.2: Draft CPMP guidelines
Table 2.3: CPMP working parties
Table 2.4: EMEA fees
Table 3.2: Status of applications under decentralised procedure 14 October 1996
Table 3.3: Implementation of the 34 directives applicable to pharmaceuticals 31 October 1996
Table 4.1: Summary of product characteristics
Table 5.1: CPMP biotechnology guidelines
Table 5.2: CPMP biologicals guidelines
Table 8.1 CPMP guidelines on pharmacovigilance
Table 9.1: Recent CPMP guidelines on GMP
Table 9.2: CPMP clinical guidelines

List of Figures

Figure 3.1: Decentralised procedure

Regulatory

No additional author information available for this product