Life Sciences - Regulation

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Recent Articles

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    04/12/2024
    China

    A New Adventure for Wholly Foreign Invested Hospital

    1. Brief Summary of Development of Wholly Foreign-Invested Hospitals Regulations in the People’s Republic of China (“PRC”)Wholly foreign-invested hospitals have always been a sector under relatively strict regulation in the PRC, except for limited cases as pilots. One of the very first legal documents allowing foreign investors to set up wholly foreign invested hospitals is the Tentative Administrative Measures on Wholly Foreign Invested Medical Institutes of China (Shanghai) Pilot Free Trade Zones issued on 13 November 2013. This regulation focuses on the procedures and conditions...
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    04/12/2024
    Hungary

    Hungary to introduce new statistical classification for economic activities on 1 January 2025

    As of 1 January 2025, a new version of the statistical industrial classification of activities (NACE’25) will replace the currently applicable classification system (NACE’08). The change was mandated by EU legislation, and as a result from 1 January 2025 economic activities pursued by Hungarian companies must be classified according to the new NACE’25.Hungary’s parliament has just adopted the act outlining the obligations of Hungarian companies regarding the upcoming changes to the activity-classification system specified below.Until 31 January 2025, the National Tax and...
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    20/11/2024
    China

    China’s NMPA issues more detailed requirements for overseas drug MAHs and their domestic responsible persons

    On 13 November 2024, the National Medical Products Administration (NMPA) formally promulgated the Interim Provisions on the Administration of the Designation of Domestic Responsible Persons by Overseas Drug Marketing Authorisation Holders. These Interim Provisions further clarify the requirements and related obligations for overseas drug Marketing Authorisation Holders (MAHs) when selecting their domestic responsible persons (DRPs).In recent years, China has strengthened regulatory supervision in the life sciences sector. A key part of China's regulatory framework, the DRP system ensures the quality...
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    07/11/2024
    Europe

    A clinical trial protocol as a pointer to the claimed crystalline form of a compound (T 1152/21)

    In recent decision T 1152/21, the Board of Appeal finds that a phase I and phase II clinical trial protocol provided a pointer to the claimed crystalline form of a compound, despite the lack of any trial results.BackgroundClaim 1 of the main request was directed to a crystalline polymorph Form A of the free base of palbociclib with particular characteristics, including a particular BET Nitrogen measured specific surface area and volume mean diameter characterized by a D[4,3] value.“According to the patent (paragraph [0004]), using palbociclib as a potent and selective CDK4/CDK6 inhibitor...
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    23/10/2024
    China

    Supreme People’s Court Issued Interpretation on Punitive Damages for Food and Drug Disputes

    The Supreme People's Court (“SPC”) of the People's Republic of China (“PRC”) has recently promulgated the Interpretation on Several Issues Concerning the Application of Law to the Trial of Cases of Disputes over Punitive Damages in Food and Drugs (“Interpretation”), taking effect from August 22, 2024. The Interpretation has 19 articles in total covering various aspects regarding punitive damages related to food and drug as prescribed in related laws. This newsletter will focus on punitive damages in the food sector only.The history of punitive damages in the...
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    14/10/2024
    China

    Temporary Import of Clinically Urgent Use Medical Devices

    On 19 July 2024, the National Medical Products Administration and the National Health Commission jointly issued the Announcement on the Temporary Import and Use of Clinically Urgent Medical Devices for Medical Institutions, with immediate effect. On 14 September 2024, Beijing Drug Administrative Authority, together with three other local departments, issued the Beijing Municipal Implementation Plan for Facilitating the Temporary Import of Clinically Urgent Use Medical Devices (Trial).  Please see our newsletter here with a brief introduction on the temporary import of clinically urgent medical...
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