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开启直播电商合规新纪元 |《直播电商监督管理办法》重点解读（下）
日前，市场监管总局、国家网信办联合发布...
Fangda Partners
China: Life Sciences, Biotechnology & Nanotechnology
Welcome to the Mondaq Food, Drugs, Healthcare, Life Sciences homepage, here you will find thought leadership articles, podcasts, videos and webinars providing insights covering topics such as Food and Drugs Law, Healthcare, Life Sciences, Biotechnology and Nanotechnology.
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A Legal Commentary On The Latest Implementing Regulations Of The PRC Drug Administration Law
On January 16, 2026, the State Council of the People's Republic of China promulgated the revised Regulations for the Implementation of the Drug Administration Law (the "Implementing Regulations")...
Fangda Partners
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China Newsletter | Q3 2025/Issue No. 65
This China Newsletter provides an overview of key developments in the following areas...
Greenberg Traurig, LLP
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Navigating China's Health Transformation: Opportunities And Challenges For Multinationals
With the core goal of achieving health equity by 2030 — meaning the elimination of health disparities to give all Chinese citizens a fair opportunity to be healthy — Healthy China 2030 stands...
Ankura Consulting Group LLC
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Tips For Pharmaceutical Use Claims
Chang Tsi & Partners
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Ten Minefields: A Guide To Avoiding Pitfalls In Applying For Human Genetic Resources Projects In China
Han Kun Law Offices
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China Released Draft Medical Device Law For Comments
Han Kun Law Offices
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Understanding China's Pharmaceutical Patent Linkage System: Framework And Case Overview (Part 1)
Chang Tsi & Partners
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生物医药领域符合WIPO标准ST.26的序列表制作经验
CCPIT Patent & Trademark Law Office
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China Life Sciences Compliance Update: Insurance Fraud Enforcement Campaign And New Ethical Code For HCPs
Arnold & Porter
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China Life Sciences Compliance Update: Kickback And Third-Party Case Study
Arnold & Porter
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Understanding The EU's International Procurement Instrument
Crowell & Moring LLP
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汉坤 • 观点 | 《药品管理法实施条例》（修订草案）重点快评
Han Kun Law Offices
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汉坤 • 观点 | 中国药品年度报告制度简析
Han Kun Law Offices
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最高人民法院"洛阳航空工程建设有限公司与（韩国）国民银行株式会社等信用证纠纷案"二审判决书*简述与点评
Beijing Jincheng Tongda & Neal Law Firm
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规范与自律同行——美国国家广告司（NAD） 广告自律机制和程序解析（二）
Beijing Jincheng Tongda & Neal Law Firm
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"信托新政"的四大纲要和三点建议——写在《信托公司管理办法》修订之后
Beijing Jincheng Tongda & Neal Law Firm
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英国毕业生签证最新要求和新规解析｜UK Graduate Visa Rules & Requirements (Video)
Latitude Law
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海南封关后文旅产业的机遇与挑战（二）：零关税制度体系详解与企业发展机遇及风险管控
AnJie Broad Law Firm
Article
汉坤 • 观点 | 简评新版《医疗器械临床试验质量管理规范（GCP）》
自国务院于2015年发布《关于改革药品医疗器械审评审批制度的意见》（国发〔2015〕44号）并启动药品医疗器械审评审批制度改革工作以来，我国不断߾
Han Kun Law Offices
Article
Compliance Highlights And Strategies In High-Risk Clinical Research Landscape
近期，部分医药行业动态引发了广泛关注，临床研究合规问题再次成为众多企业重点讨论的话题。
Han Kun Law Offices
Article
Han Kun • Opinion | Settle The Dust Or Let The Bullets Fly: Biden Administration Signs Executive Order On Promoting Biotechnology And Biomanufacturing Innovation
On September 12, 2022, U.S. President Joe Biden signed the Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable...
Han Kun Law Offices
Article
Han Kun • Opinion | Finally Waiting For You - Interpreting The New Policy Of Cross-border Contract Production Of Drugs And Medical Devices In The Guangdong-Hong Kong-Macao Greater Bay Area
On June 29, 2022, the National Medical Products Administration ("NMPA") publicly released the "Implementation Plan for Supporting Hong Kong and Macao Drug Marketing Authorization Holders...
Han Kun Law Offices
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Han Kun • Opinion | Interpretation Of China's Annual Drug Review Report (2015-2021) - Review Of The Reform Of Our Country's Drug Review And Approval System (Part II)
Han Kun Law Offices
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Han Kun • Opinion | Interpretation Of China's Annual Drug Review Report (2015-2021) - Review Of The Reform Achievements Of Our Country's Drug Review And Approval System (Part II)
Han Kun Law Offices
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汉坤 • 观点 | 医药BD项目如何友好"分手"？
Han Kun Law Offices
Article
How Digital Therapeutics (DTx) Products Are Regulated In China?
Han Kun Law Offices
Article
生命科学行业License-in/out合同争议要点分析（三）：不竞争条款
Han Kun Law Offices
Article
2024 Data Analytics: China Life Sciences NewCo & Licensing Terms
Han Kun Law Offices
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Han Kun • Opinion | Hainan Boao Lecheng Clinical Urgently Needs A Review Of The Highlights Of The New Regulations On The Management Of Imported Drugs And Devices
Han Kun Law Offices
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Han Kun • Opinion | Key Points For The Supervision Of Medical And Three-Product And One-Device Advertising Under The New Regulations On Internet Advertising
Han Kun Law Offices
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Han Kun • Opinion | Brief Review Of The Measures For The Review Of Science And Technology Ethics (Trial) (Draft For Comments)
Han Kun Law Offices
Article
汉坤 • 观点 | CAR-T/NK监管路在何方 — 体细胞临床研究工作指引（征求意见稿）要点解读
Han Kun Law Offices
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Han Kun • Opinion | Hainan Boao Lecheng Clinical Urgently Needs A Review Of The Highlights Of The New Regulations On The Management Of Imported Drugs And Devices
On March 28, 2023, the Hainan Provincial People's Government officially issued the "Regulations on the Administration of Imported Drugs and Medical Devices Urgently Needed in Clinical Needs...
Han Kun Law Offices
Article
Han Kun • Opinion | Key Points For The Supervision Of Medical And Three-Product And One-Device Advertising Under The New Regulations On Internet Advertising
On March 24, 2023, the State Administration for Market Regulation publicly issued the "Measures for the Administration of Internet Advertising" (the "Measures")...
Han Kun Law Offices
Article
Han Kun • Opinion | Brief Review Of The Measures For The Review Of Science And Technology Ethics (Trial) (Draft For Comments)
On April 4, 2023, the Ministry of Science and Technology released the "Measures for Science and Technology Ethics Review (Trial) (Draft for Comments)" ("Draft for Comments")...
Han Kun Law Offices
Article
汉坤 • 观点 | CAR-T/NK监管路在何方 — 体细胞临床研究工作指引（征求意见稿）要点解读
2023年5月9日，国家卫健委科教司发布《体细胞临床研究工作指引（征求意见稿）》（" 《征求意见稿》"），并面向社会公开征求意见。体细胞治疗
Han Kun Law Offices
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Han Kun • Opinion | Interpretation Of The New Administrative Guidelines For Human Genetic Resources
Han Kun Law Offices
Article
药企出海新热点：管线分拆"SON"模式的实践解读
近期，医药行业正掀起一股"管线分拆项目"（"Spin off-NewCo"，或称"SON"模式）的热潮。短短两个月，笔者即接手了近十起管线分拆项目。
Han Kun Law Offices
Article
Han Kun Opinion | Breaking News: 10 Questions And Answers On Pharmaceutical Anti-Corruption In 2023
Recently, a nationwide campaign to combat corruption in the pharmaceutical sector has been underway in full swing, attracting widespread attention from the industry...
Han Kun Law Offices
Article
Han Kun Opinion | CAR-T/NK Regulatory Decisions — Interpreting The "Guidelines For Somatic Cell Clinical Research (Trial)"
On August 18, 2023, the China Medical Biotechnology Association (CMBA), commissioned by the Department of Science and Technology of the National Health Commission (" NHC ")...
Han Kun Law Offices
Article
汉坤 • 观点 | 从药械产品全生命周期视角解读License-in/out许可交易项目合作条款要点
创新药械的研发，是一场依托于企业团队的专业技术实力、满载着从业人员的热情与信念、又充满了各种冒险与挑战的旅程，结天时地利人和
Han Kun Law Offices
Article
汉坤 • 观点 | 企业或需自设伦理委员会：《科技伦理审查办法（试行）》正式出台
Han Kun Law Offices
Article
Han Kun • Viewpoint | Interpretation Of The "Annual Report On The Progress Of Clinical Trials For New Drug Registration In China (2022)"
Han Kun Law Offices
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Han Kun • Opinion | 2023 Life Sciences Regulatory Compliance Annual Summary
Han Kun Law Offices
Article
Han Kun • Opinion | Quick Review Of The New Regulations: Interpret The Latest Questions And Answers Of The Ministry Of Science And Technology
Han Kun Law Offices
Article
Han Kun • Quick Comment | Is The Transmission Of Cross-border Genomic Data Between China And The United States Blocked? Biden Data Executive Order Quick Review
Han Kun Law Offices
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Han Kun • Opinion | Analysis Of Key Points Of License-In/out Contract Disputes In The Life Sciences Industry (1): Joint Steering Committee, Reasonable Commercial Efforts, Confidentiality Obligations
Han Kun Law Offices
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Hankun • Quick Comment | The Regulations On Human Genetic Resources Management Are Revised Again
Han Kun Law Offices
Article
The New Regulations On Medical Aesthetics Came Into Effect Today - The Supervision Of Radio Frequency Beauty Devices Such As Thermage And Heatlifter Has Been Upgraded
Han Kun Law Offices
Article
More Than 60 Innovative Drugs Were Approved: Interpretation Of The Highlights Of The 2022-2023 China Drug Review Report
Han Kun Law Offices
Article
2022-2023 China Medical Device License-In/Out Project Core Clause Data Analysis
Han Kun Law Offices
Article
61款创新医疗器械获批：2023年度中国医疗器械注册工作报告亮点解读
Han Kun Law Offices
Article
Overview: 2022-2023 China Drug & Medical Device Annual Report
Han Kun Law Offices
Article
Top 10 Traps To Avoid: Navigating China's HGR Applications
Han Kun Law Offices
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观点 | 生命科学行业License-In/Out合同争议要点分析（二）：适应症变更、监管要求变更、合同变更或解除
Han Kun Law Offices
Article
Insights Into China Biotech's New Approach: Spin-Off-NewCo Model
Han Kun Law Offices