Medical Product Regulatory Affairs E-Book

John J. Tobin

• Herausgeber: Wiley-VCH
• Kategorie: Wissenschaft und neue Technologien
• Sprache: Englisch
• Veröffentlichungsjahr: 2011

Seitenzahl: 355

Beschreibung

Written in a clear and concise style by an experienced author, this attractively-priced book covers regulatory affairs in all major global markets for pharmaceuticals and medical devices, making it the most comprehensive in its field. Following a look at drug development, complete sections are devoted to national and EU regulatory issues, manufacturing license application and retention, and regulation in the USA. Other topics dealt with include CDER, CBER and marketing and manufacturing licenses, the ICH process and Good Laboratory/Clinical/Manufacturing Practices. Everything pharmacologists, bioengineers, pharma engineers, students in pharmacy and those working in the pharmaceutical industry need to know about medical regulatory affairs.

Leseprobe

Contents

Preface

1 The Aims and Structure of Regulations

1.1 Introduction

1.2 Purpose and Principles of Regulation

1.3 The Legal Framework for Regulation

1.4 Basic Legislation

1.5 Scope of the Legislation

1.6 Chapter Review

1.7 Further Reading

2 Regulatory Strategy

2.1 Chapter Introduction

2.2 Basic Regulatory Strategy

2.3 Quality Assurance Systems

2.4 Validation

2.5 Regulatory Bodies

2.6 International Harmonisation Bodies

2.7 International Conference on Harmonisation

2.8 Pharmaceutical Inspection Cooperation Scheme

2.9 The World Health Organization (WHO)

2.10 Chapter Review

2.11 Further Reading

3 Drug Discovery and Development

3.1 Chapter Introduction

3.2 Drug Categorisation

3.3 Drug Discovery

3.4 Drug Development

3.5 Drug Delivery

3.6 Chapter Review

3.7 Suggested Reading

4 Non-Clinical Studies

4.1 Chapter Introduction

4.2 Non-Clinical Study Objectives and Timing

4.3 Pharmacological Studies

4.4 Bioavailability and Bioequivalence

4.5 Toxicology Studies

4.6 Chemistry, Manufacturing and Control Development (CMC)

4.7 Quality of Biotech Products

4.8 Good Laboratory Practice (GLP)

4.9 Chapter Review

4.10 Further Reading

5 Clinical Trials

5.1 Chapter Introduction

5.2 Clinical Trials

5.3 Clinical Trial Design

5.4 Good Clinical Practice

5.5 Clinical Trials in the EU

5.6 Clinical Trials in The US

5.7 Chapter Review

5.8 Further Reading

6 Marketing Authorisation

6.1 Chapter Introduction

6.2 The Application Dossier

6.3 CTD

6.4 Submission and Review Process in the EU

6.5 Submission and Review Process in the US

6.6 Chapter Review

6.7 Further Reading

7 Authorisation of Veterinary Medicines

7.1 Chapter Introduction

7.2 Overview of Development Process for Veterinary Medicines

7.3 Authorisation of Clinical Trials in the EU

7.4 Authorisation of Clinical Trials in the US

7.5 Maximum Residue Limits

7.6 Authorisation of Veterinary Medicines in the EU

7.7 Approval of Veterinary Medicines in the US

7.8 Chapter Review

7.9 Further Reading

8 Variations to the Drug Authorisation Process

8.1 Chapter Introduction

8.2 Provisions in Support of Special Drug Applications

8.3 Accelerated Access to New Drug Therapies

8.4 Approval of New Drugs when Human Efficacy Studies are not Ethical or Feasible

8.5 Animal Drugs for Minor Use and Minor Species

8.6 Use of Non-Authorised Drugs for Animal Treatment in the EU

8.7 Changes to an Authorised Drug

8.8 EU System for Processing Changes

8.9 Processing Changes in the US

8.10 Authorisation of Generic Drugs

8.11 Reference Drug Exclusivity

8.12 Other Authorisation Procedures

8.13 Chapter Review

8.14 Further Reading

9 Medical Devices

9.1 Chapter Introduction

9.2 Regulatory Strategy for Medical Devices in the EU

9.3 Regulatory Strategy for Medical Devices in the US

9.4 Development of Devices

9.5 Chapter Review

9.6 Further Reading

10 Authorisation of Medical Devices

10.1 Chapter Introduction

10.2 Evaluation of Medical Devices in Europe

10.3 Evaluation of Medical Devices in the US

10.4 Placing of Devices on the Market in the EU

10.5 Placing of Devices on the Market in the US

10.6 Chapter Review

10.7 Further Reading

11 Good Manufacturing Practice (GMP)

11.1 Chapter Introduction

11.2 Drug GMP Regulations and Guidance

11.3 Essential GMP Requirements

11.4 Validation

11.5 GMP Requirements for Devices

11.6 Chapter Review

11.7 Further Reading

12 Oversight and Vigilance

12.1 Chapter Introduction

12.2 Registration of Manufacturers and Other Entities

12.3 Manufacturing Authorisation of Medicinal Products in the EU

12.4 Registration of Producers of Drugs and Devices in the US

12.5 Inspections

12.6 Market Vigilance and Oversight of Drugs

12.7 Advertising and Promotion

12.8 Market Vigilance and Oversight of Devices

12.9 Chapter Review

12.10 Further Reading

Index

The Authors

Dr. John J. TobinChemHaz Solutions Ltd.Laccaroe, FeakleCounty clareIreland

Prof. Dr. Gary WalshChemical and Environmental SciencesDepartmentUniversity of LimerickCastletroy, Limerick CityIreland

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© 2008 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim

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Preface

Medical Product Regulatory Affairs aims to introduce and overview the regulatory affairs framework governing the development, approval, manufacturing and surveillance of both pharmaceuticals and medical devices, including in-vitro diagnostic products. The book focuses upon the regulatory framework and practice within the European Union and the United States of America, while also outlining global regulatory harmonization measures driven by the International Conference on Harmonization initiative. It should also serve as a reference source for those wishing to work in regulatory affairs, as well as for non-regulatory pharmaceutical/healthcare industry scientists and managers. The scope of this book should also render it a useful reference source for third-level students undertaking healthcare-related programmes of study (e.g. undergraduate or taught postgraduate programs in pharmacy, pharmaceutical science, (bio)materials science, biotechnology or applied biology).

Likewise, it should serve as a useful reference for academic and industry researchers whose research interests relate to the pharmaceutical, diagnostic, or medical device sector.

We would like to gratefully acknowledge EMEA, ISO, EDQM, PIC/S, IMB, ISPE and Health Canada that granted us permission to reproduce selected copyrighted material. We reserve a special acknowledgement and thanks to the European Commission, the FDA and the ICH secretariat, the VICH and the GHTF, who have placed their regulatory documentation in the public domain, and we have reproduced several documents from these sources herein.

Finally we dedicate this book to our parents.

December 2007.

J.J. TobinG. Walsh

1

The Aims and Structure of Regulations

1.1 Introduction

Drugs and medical devices are among the most stringently regulated products in the developed world. This chapter introduces you to the basic principles and concepts behind the regulations so that you can fully appreciate the importance of compliance. The chapter then looks at the general legislative framework that is used to create regulations and identifies the core legal texts that are used to regulate such products in the European Union (EU) and the United States of America (US). Finally, the chapter examines the legal definitions of drugs and medical devices, which are central to determining the scope of the regulations.

1.2 Purpose and Principles of Regulation

The fundamental purpose of regulation is the protection of public health.

Although this appears a very simple goal, its attainment has required the development of extensive and complex regulations. As a newcomer to the subject, you may find some of the regulation cumbersome and overbearing. However, as you study this chapter, you will see that many of the landmark advances in regulatory development were triggered by adverse incidents. Thus, you should accept the current regulations as representing the distilled wisdom of past experience.

To achieve their goal, the regulations rely on a number of core principles and concepts:

SafetyEfficacyPurposeRisk/benefitQuality

Product safety is an underlying principle for all products. Ideally, the product should do no harm. Thus, the regulations require that the developer or manufacturer must take appropriate steps to demonstrate and ensure the safety of the product under development.

Obviously, for it to be worthwhile, the product must also do some good. Hence, the principle of efficacy or effectiveness has become another cornerstone in achieving the goal of regulation. To evaluate effectiveness you must also consider the purpose of the product as expressed in either an indications for use statement in the case of drugs, or intended use statement in the case of medical devices. As discussed in Section 1.6, and later in Sections 9.3 and 9.4, intended use statements are also vital in determining how some products are regulated in the first place, which in turn dictates the level of scrutiny to which they may be subjected.