De Gaulle Fleurance & Associés contributed to the 8th edition of the International Journal of Life Sciences Law The Life Sciences Law Review. Published in April 2020, this edition covers around thirty countries from different continents and provides an overview of their regulations governing the activities of companies in the sector, whether in particular pharmaceutical laboratories, manufacturers of medical devices or biotechnology companies.
The chapters are arranged so as to describe requirements throughout the life cycle of a regulated product, from discovery to clinical trials, the marketing authorization process and post-approval controls. Certain other legal matters of special interest to manufacturers of medical products – including administrative remedies, pricing and reimbursement, competition law, special liability regimes and commercial transactions – are also covered.
Finally, there is a special chapter on international harmonisation, which is of increasing importance in many of the regulatory systems that are described in the national chapters.
“AN EFFICIENT AND USEFUL COMPARATIVE INTERNATIONAL LAW TOOL”
The past year has seen a number of significant developments. European Union regulation is undergoing a profound change with the new Medical Device Regulation although its enforcement has been postponed by one year due to the COVID-19 crisis. The United States are considering measures to improve the transparency of pricing for prescription drugs. The United Kingdom is addressing changes to regulatory systems that must accompany the country’s withdrawal from the EU, and drug and device manufacturers are actively planning for the effects of Brexit on their supply chains. The governments in India and China continue to transform their regulatory systems for drugs and medical devices.
All the chapters have been written by recognized experts in their country. Cécile Théard-Jallu and Xavier Vuitton, respectively Partner and Of Counsel at De Gaulle Fleurance & Associés, were thus asked to take care of the chapter devoted to France. “We are delighted to have contributed to this publication, the quality of which is recognized worldwide“, explain Cécile Théard-Jallu and Xavier Vuitton. “It is an efficient and useful comparative international law tool, helping companies in the healthcare and life sciences sector adapt to a rapidly changing regulatory context in a more and more globalized environment. ”
Read The Life Sciences Law Review Edition 8
Read the French chapter written by De Gaulle Fleurance & Associés
Published with permission from Law Business Research Ltd
This 8th edition was first released in April 2020
For further information about the Life Sciences Law Review, please contact Nick.Barette@thelawreviews.co.uk
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