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The second edition of The Life Sciences Law Review provides an overview of legal issues of interest to pharmaceutical, biotechnology and medical device companies in 30 jurisdictions. As before, each chapter contains information on legal requirements relating to the key stages in the life cycle of a regulated product, from discovery, through the clinical development process, registration, manufacturing and promotion, plus other issues of special interest, such as pricing and reimbursement, special liability regimes, competition and commercial transactions in the context of the medical products business. Each of the chapters has been prepared by a recognised expert in the relevant jurisdiction, and the resulting work product will assist industry lawyers, regulatory affairs staff and others who need to have an understanding of the issues in each major market.
This edition also includes a new chapter on international harmonisation, which plays an increasingly important role in the regulation of pharmaceuticals and medical devices. In particular, the guidelines adopted by the International Conference on Harmonisation (ICH) have been incorporated into the national requirements for pharmaceuticals in the European Union, United States, Japan and most other developed countries, and are increasingly influential in developing countries. Readers may find it useful to review this chapter before consulting the national chapters, because it is often key to understanding many of local requirements.