Welcome to the Q3 2018 issue of our Life Sciences International Review. This issue covers life sciences developments within Europe, Asia, and the United States in the areas of intellectual property, regulatory, pricing and reimbursement, international trade, litigation, and competition, and provides the latest on the ongoing Brexit saga.
Major news this quarter includes a recent Court of Justice ruling that gives guidance on the Specific Mechanism for the parallel import of medicinal products, EU guidance on adapting existing good clinical practice to advanced therapy medicinal products, MedTech Europe’s concerns about the implementation of the new Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation, the US Food and Drug Administration’s recently unveiled Biosimilars Action Plan, and much more.
Many of the topics covered in this issue are ongoing. The Life Sciences International Review team continues to monitor developments and will include updates in future issues to keep our readers up to date with the latest events and trends in the life sciences industry.