A Practical Guide to European Pharmaceutical Regulations for Human Medicines

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A Practical Guide to European Pharmaceutical Regulations for Human Medicines

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The life sciences industry represents one of the dominant economic sectors in the UK. Given the complexity of the European Regulatory Framework relating to the supply of human medicinal products this book gives an authoritative overview of the law as it currently stands.

This practical guide will address the regulatory procedures and day to day challenges for the authorisation and use of human medicinal products in the EU’s most regulated industry.

User-friendly, practical and pragmatic this book will prove an invaluable source of information for those who work in industry, regulatory authorities and for all persons who need to familiarise themselves with the relevant legislation in this fast moving industry sector.

Chapter One – Regulating Human Medicines in the European Union

The Legal Basis of Medicines for Human Use

The Quality, Safety and Efficacy of a Medicine

The History and Progress of EU Regulation for Human Medicines

The European Medicines Agency Scientific Committees

The Future of Medicines in Europe?

Chapter Two – Clinical Trials for Human Medicines

Background

Clinical Trial legal framework

Clinical Trial Protocol

Clinical Trial Agreements

Clinical Trial Patient Confidentiality and Informed Consent

Subject withdrawal from the Clinical Trial

Qualified Person (QP) Certification

Clinical Trial Stages

Chapter Three – Pharmaceutical Quality Systems

Introduction

Various types of GxP

Good Pharmacovigilance Legislation

Chapter Four – Pharmacovigilance in Human Medicines

The Need for Pharmacovigilance

The Pharmacovigilance Process

Pharmacovigilance Systems and Risk Assessment

Periodic Benefit Risk Evaluation (PBRER)

Periodic Safety Update Reports (PSURs)

Pharmacovigilance Legislation

Reporting of Adverse Reactions

European EudraVigilance

European-Wide Monitoring of Medicines

Safety Recalls

Chapter Five – Marketing Authorisation and Variation Procedures for Human Medicinal Products

The Requirement for a Marketing Authorisation

The Marketing Authorisation Holder (MAH)

Marketing Authorisation Applications (MAA)

The Common Technical Document (CTD)

Marketing Authorisation Procedures

Alternative Approval Pathways for Medicines

Advanced Therapy Medicinal Products (ATMP)

Marketing Authorisation Renewal and Transfer

Variations and Extensions of a Marketing Authorisation

Urgent safety restrictions

Extensions of a Marketing Authorisation

Chapter Six – Data Exclusivity and Market Protection for Human Medicines

Background

Extension of Market Protection and Data Exclusivity

Duties and Powers of National Regulatory Authorities and National Courts governing Data Exclusivity

Supplementary Protection Certificate (SPC)

Proposed European Export Manufacturing Waiver

Chapter Seven – The Advertising of Prescribed Human Medicines

Introduction

Legislative framework

Voluntary Codes of Practice – The European Federation of Pharmaceutical Industries and Associations (EFPIA)

Control of Medicine Advertisement by the MHRA

The Advertising Standards Authority (ASA)

Additional Legislation Governing the Advertising of Medicines in the UK

Chapter Eight – The Pricing and Reimbursement of Human Medicines

Introduction

The Transparency Directive 89/105/EEC

Health Technology Assessment (HTA)

The National Institute for Health and Clinical Excellence (NICE)

Generic medicines

Patient Access Scheme (PAS)

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