Guide to EU and UK Pharmaceutical Regulatory Law (Ninth Edition), 2025, Edited by Sally Shorthose and Pieter Erasmus

The Guide to EU and UK Pharmaceutical Regulatory Law is a unique volume that provides up-to-date information on the processes, legislation, cases, and customs that apply to the introduction, marketing, and sale of a medicinal product (or a medical device) in Europe. Competition law has always been crucial to the pharmaceutical sector since the industry is highly competitive and involves many intellectual property rights. In the European Union (EU), its Member States and the United Kingdom (UK) post-Brexit, as elsewhere, the marketing of pharmaceuticals is subject to an ever more complex web of legislation and regulation, resulting from the intense scrutiny necessary to ensure such essential products are not only efficacious but also safe.

What's in this book:

Following brief introductory chapters that provide an overview of the regulatory framework for pharmaceuticals in Europe, a short discussion of how the overarching EU regulatory regime is poised to change in the coming years, and how the exit from the EU by the UK currently affects the regulatory regime, each of the following twenty-one incisive chapters examines a particular process or subject from an EU and UK-wide perspective. Among the many topics and issues covered, including the all-new chapter on artificial intelligence, are the following:

• clinical trials;
• stages and standards for creating a product dossier;
• obtaining a marketing authorisation;
• how and when an abridged marketing authorisation procedure can be used;
• criteria for conditional marketing authorisations;
• generic products and 'essential similarity';
• paediatric use and the requisite additional trials;
• orphan medicinal products;
• biologicals and 'biosimilars';
• homoeopathic, herbal and similar medicines;
• medical devices;
• pandemics, epidemics and vaccines;
• pharmacovigilance;
• parallel trade;
• advertising;
• relevant competition law, intellectual property rights and data protection regulation; and
• artificial intelligence (**new chapter**). 

This unique book will be highly appreciated by pharmaceutical lawyers and regulatory advisers, both in-house and in private practice. It will prove invaluable for all who need to understand the process of bringing a medicinal product or medical device to market and the continuing rights and obligations.

To find out more about this book, click here or reach out to our experts Sally Shorthose and Pieter Erasmus directly.

Edited by Sally Shorthose and Pieter Erasmus, and contributed to by our Life Sciences Regulatory experts from across Europe: 

Belgium: Marc Martens, Kevin Munungu, Benedicte Mourisse and Maarten Princen
Denmark: Morten Nissen and Alexander Brøchner
Finland: Sofia Paksuniemi
France: Caroline Arrighi-Savoie, Johanna Harelimana and Nour Saab
Germany: Christian Lindenthal, Dr. Annika Lückemann, Dr. Jan van Dieck and Annelie Säurig
Ireland: Deirdre Kilroy, Denis Halton and Kelly Mackey
Italy: Mauro Turrini
Netherlands: Hester Borgers, Anna Koster, Edzard Boonen and Maud van Haaren
Poland: Andrzej Stelmachowski
Spain: Coral Yáñez and Alejandra Inés Vicario Calleja 
Sweden: Ana-Maria Barbu-Nyström and Gunnar Hjalt
UK: Sally Shorthose, Sarah Faircliffe, Peter Willis, Mark Day, Patrick Brown, Pieter Erasmus, Sophie Vo and Phillipus Putter

Published by Wolters Kluwer