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Nadezhda Fedotova of Lidings law firm gives an update on recent amendments to the labeling legislation for medicines in Russia, their potential impact on the Russian pharmaceutical industry, and the numerous uncertainties still remaining.   "Despite the time moving up to January 1, 2020, it seems impossible to say whether the drugs labeling system will or will not be launched in time completely."   Under the Decree of the Government of the Russian Federation No. 1556 dated December 14, 2018 (hereinafter – Decree No. 1556), the monitoring system of the medical drugs circulation should become effective from the January 2020...

Author: Nishith Desai & Associates     2019 so far has witnessed a lot of activity in the pharma space, so much so that the e-pharmacy saga – a pressing development towards the close of 2018 – has taken a temporary backseat this year. Instead, the new stars of 2019 so far have been price regulation and regulation of electronic nicotine delivery systems. 2019 also saw a significant piece of legislation introduced – the New Drugs and Clinical Trial Rules, 2019 – which has already begun making waves in the industry. Some of the major developments that have taken place so...

  Fangda Partners’ Josh Shin gives an overview of recent regulatory upgrades affecting the Chinese pharmaceutical industry.   On August 26, 2019, China enacted the Amended Drug Administration Law as part of its efforts to strengthen and streamline its regulation of the pharmaceutical industry. The amended law seeks to address prominent problems in the pharmaceutical industry, such as counterfeit drugs, substandard drugs and high drug prices. To address these problems and to accomplish other goals, the Amended Drug Administration Law will place strict supervisory standards and measures over the entire pharmaceutical industry, including R&D, manufacturing, sales, and end-use and management...

  PharmaBoardroom is proud to collaborate with Fasken, an international law firm with 700 lawyers and 10 offices on four continents. One of its lawyers, Jean-Raphaël Champagne, has assisted on various questionnaires and has co-authored legal articles focusing on health and life sciences in Canada.Jean-Raphaël advises clients on issues related to commercial and regulatory law in the technology and life sciences sectors. He has extensive experience drafting legal opinions on regulatory compliance with Health Canada, the rules governing advertising and the ethical standards applicable to the pharmaceutical industry.He also counsels clients on cannabis-related issues. Jean-Raphaël advises clients on the complex regulatory...