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Hogan Lovells | USA | 21 Sep 2020

China’s NMPA releases proposal for modified “Hatch Waxman” following patent law reform

On 11 September 2020, China’s National Medical Products Administration (NMPA, formerly “China Food and Drug Administration”) published its proposed…
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CCPIT Patent & Trademark Law Office | China | 24 Aug 2020

Introduction to the recent Draft Amendments to Patent Law

On June 20, 2020, the Standing Committee of the National People's Congress (NPC) published its 2020 version of draft amendments to Patent Law (2020…
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Peksung Intellectual Property Ltd | China | 20 Apr 2020

中国仿制药的发展现状分析

仿制药是指与原研药在剂量、安全性、效力、质量、药效以及适应症上均相同的一种仿制药品。现代仿制药起源于1984…
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Hogan Lovells | China | 27 Mar 2020

China takes a pragmatic approach to relaxing regulation of the life sciences sector during COVID-19

As the coronavirus (COVID-19) spreads across the world, creating new epicenters, this is perhaps an opportune moment to look back at the lessons…
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Morgan, Lewis & Bockius LLP | USA | 12 Mar 2020

Recent FDA Medical Device Developments in Response to COVID-19

The US Food and Drug Administration is working to facilitate emergency use authorization for coronavirus (COVID-19) medical devices, including…
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Global Law Office | China | 6 Mar 2020

药物临床试验不良事件纠纷的民事责任分析

对于药物而言,临床试验的重要性是不言而喻的,药物的有效性与安全性都需要通过临床试验进行检验。据统计,我国每年有800多种新药进行人体试验,涉…
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Global Law Office | China | 4 Mar 2020

拓展性临床试验在突发公共卫生事件中的应用

2020年1月20日,国家卫生健康委员会发布1号公告,将新型冠状病毒感染的肺炎纳入《中华人民共和国传染病防治法》规定的乙类传染病,并采取甲类传染病的预防…
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Keller and Heckman LLP | USA | 27 Feb 2020

FDA Data Shows an Increase in Food Facility Violations for Failing to Develop a Foreign Supplier Verification Program

According to the Food and Drug Administration’s (FDA) Inspection Observation Data for the Fiscal Year 2019, the most commonly cited violation during…
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Paul Hastings LLP | China, USA | 23 Jan 2020

What Drug Companies Should Be Thinking About After the U.S. - China Trade Deal

On January 15, 2020, the United States and China announced an economic and trade deal (“Phase One Trade Agreement”) that could significantly improve…
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VISCHER AG | China | 31 Oct 2019

China Adopts Modern Drug Legislation

The Chinese healthcare system is currently undergoing significant changes. With the most extensive amendments in the past decade, the Drug…
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