‘A Guide to European Pharmaceutical Regulations for Human Medicines’ by Cliodhna McDonough
Published: September 2019
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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 addresses 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.
ABOUT THE AUTHOR
Cliodhna Mc Donough is a Legal Director at at a London based Law Firm specialising in Life sciences, Food and Medical Device Regulatory Law.
In addition to her professional career as a Regulatory Lawyer, Cliodhna holds a BSc (Hons) in Clinical Dietetics and an MSc (Hons) in EU Regulatory Affairs. Previously, Cliodhna has worked internally for life science companies and as a lead Clinical Dietitian in a Dublin teaching hospital.
Cliodhna shares her sector knowledge as both a lecturer and a board member of the Masters of Science EU Regulatory Affairs Degree at the University of College Dublin/University of Ulster and was also appointed by the Irish Minister of Health in 2013 to the Government State Board CORU which regulates Health Care Professionals.
Cliodhna has been described by clients as “first class at solving complex scientific technical issues with a pragmatic approach” and is a regular contributor to academic clinical and legal journals. She is frequently invited to join governance framework discussions with government regulatory agencies.
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
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
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)
Reporting of Adverse Reactions
European-Wide Monitoring of Medicines
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
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
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
The Transparency Directive 89/105/EEC
Health Technology Assessment (HTA)
The National Institute for Health and Clinical Excellence (NICE)
Patient Access Scheme (PAS)