China: Life Sciences, Biotechnology & Nanotechnology

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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.

Understanding The EU's International Procurement Instrument

Earlier this year, the Commission relied for the first time on the EU's International Procurement Instrument in order to take measures against China for its failure to ensure reciprocal access to public...

China Government

CM

Crowell & Moring LLP

汉坤 • 观点 | 《药品管理法实施条例》（修订草案）重点快评

2022年5月9日，国家药监局发布《药品管理法实施条例（修订草案征求意见稿）》（简称"《征求意见稿》"），向社会公开征求意见，征求意见反馈截止

China Healthcare

HK

Han Kun Law Offices

汉坤 • 观点 | 中国药品年度报告制度简析

2022年4月11日，国家药品监督管理局（" 国家药监局"）发布了《药品年度报告管理规定》以及相应的报告模板（以下合称" 《年报规定》"）...

China Healthcare

HK

Han Kun Law Offices

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߾

China Healthcare

HK

Han Kun Law Offices

Compliance Highlights And Strategies In High-Risk Clinical Research Landscape

China Healthcare

HK

Han Kun Law Offices

Han Kun • Opinion | Settle The Dust Or Let The Bullets Fly: Biden Administration Signs Executive Order On Promoting Biotechnology And Biomanufacturing Innovation

China Healthcare

HK

Han Kun Law Offices

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

China Healthcare

HK

Han Kun Law Offices

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)

China Healthcare

HK

Han Kun Law Offices

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)

China Healthcare

HK

Han Kun Law Offices

汉坤 • 观点 | 医药BD项目如何友好"分手"？

China Healthcare

HK

Han Kun Law Offices

How Digital Therapeutics (DTx) Products Are Regulated In China?

China Healthcare

HK

Han Kun Law Offices

生命科学行业License-in/out合同争议要点分析（三）：不竞争条款

China Healthcare

HK

Han Kun Law Offices

2024 Data Analytics: China Life Sciences NewCo & Licensing Terms

China Healthcare

HK

Han Kun Law Offices

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

China Healthcare

HK

Han Kun Law Offices

我国自动辅助驾驶侵权责任的探讨 ——从特斯拉自动辅助驾驶天价赔偿案和我国法院入库案例谈起

China Transport

AB

AnJie Broad Law Firm

Federal Circuit Affirms Lawfulness Of Section 301 "Lists 3 And 4A" Tariffs On China

China International

KD

Kelley Drye & Warren LLP

对《美欧关于互惠、公平与均衡贸易协议的框架的联合声明》的结构性观察

China International

JT

Beijing Jincheng Tongda & Neal Law Firm

"十不准"视角下的大宗商品虚假贸易法律风险防控要点

JT

Beijing Jincheng Tongda & Neal Law Firm

劳动法新规解读系列①：《劳动争议司法解释（二）》重点条款

China Employment

AB

AnJie Broad Law Firm

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")...

China Healthcare

HK

Han Kun Law Offices

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")...

China Healthcare

HK

Han Kun Law Offices

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

China Healthcare

HK

Han Kun Law Offices

Han Kun • Opinion | Interpretation Of The New Administrative Guidelines For Human Genetic Resources

On July 14, 2023, the Ministry of Science and Technology (hereinafter referred to as the "Ministry of Science and Technology") issued the "Notice on Updating the Service Guidelines...

China Healthcare

HK

Han Kun Law Offices

Strategic Insights For The Localization Of Pharmaceutical And Medical Device Manufacturing In China

China Healthcare

HK

Han Kun Law Offices

汉坤 • 观点 | LDT试点新规解读

China Healthcare

HK

Han Kun Law Offices

Han Kun • Opinion | Blockbuster Debut: Interpretation Of The Key Points Of The Implementation Rules Of The Regulations On The Management Of Human Genetic Resources

China Healthcare

HK

Han Kun Law Offices

观点 | 生命科学行业License-in/out合同争议要点分析（四）：首付款是否可能退回？

China Commercial

HK

Han Kun Law Offices

药企出海新热点：管线分拆"SON"模式的实践解读

China Healthcare

HK

Han Kun Law Offices

Han Kun Opinion | Breaking News: 10 Questions And Answers On Pharmaceutical Anti-Corruption In 2023

China Healthcare

HK

Han Kun Law Offices

Han Kun Opinion | CAR-T/NK Regulatory Decisions — Interpreting The "Guidelines For Somatic Cell Clinical Research (Trial)"

China Healthcare

HK

Han Kun Law Offices

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

China Healthcare

HK

Han Kun Law Offices

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

China Healthcare

HK

Han Kun Law Offices

Han Kun • Viewpoint | Interpretation Of The "Annual Report On The Progress Of Clinical Trials For New Drug Registration In China (2022)"

China Healthcare

HK

Han Kun Law Offices

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 ")...

China Healthcare

HK

Han Kun Law Offices

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

China Healthcare

HK

Han Kun Law Offices

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

2023年10月8日，中华人民共和国科学技术部（"科技部"）会同教育部、工业和信息化部等十个部门与机构共同发布了《科技伦理审查办法（试行）》

China Healthcare

HK

Han Kun Law Offices

Han Kun • Viewpoint | Interpretation Of The "Annual Report On The Progress Of Clinical Trials For New Drug Registration In China (2022)"

On September 7, 2023, the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) released the "Annual Report on the Progress of Clinical Trials...

China Healthcare

HK

Han Kun Law Offices

Han Kun • Opinion | 2023 Life Sciences Regulatory Compliance Annual Summary

China Healthcare

HK

Han Kun Law Offices

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

Today (April 1), the new regulations of the State Medical Products Administration ("NMPA") on the inclusion of radio frequency therapy devices and RF...

China Healthcare

HK

Han Kun Law Offices

More Than 60 Innovative Drugs Were Approved: Interpretation Of The Highlights Of The 2022-2023 China Drug Review Report

On February 4, 2024, our country's National Medical Products Administration (NMPA) released the 2023 Annual Drug Review Report on its official website.

China Healthcare

HK

Han Kun Law Offices

2022-2023 China Medical Device License-In/Out Project Core Clause Data Analysis

License-in/out has become the most common way for innovative drug and medical device (including medical aesthetic) companies to collaborate on the development of related technologies...

China Healthcare

HK

Han Kun Law Offices

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

在前一篇文章《60余款创新药获批：2022-2023年度中国药品审评报告亮点解读》中，我们对2022-2023年度药品审评报告中所体现的我国近两年药品注册与监管

China Healthcare

HK

Han Kun Law Offices

Ten Minefields: A Guide To Avoiding Pitfalls In Applying For Human Genetic Resources Projects In China

China Healthcare

HK

Han Kun Law Offices

Overview: 2022-2023 China Drug & Medical Device Annual Report

China Healthcare

HK

Han Kun Law Offices

Top 10 Traps To Avoid: Navigating China's HGR Applications

China Healthcare

HK

Han Kun Law Offices

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

China Healthcare

HK

Han Kun Law Offices

Insights Into China Biotech's New Approach: Spin-Off-NewCo Model

China Healthcare

HK

Han Kun Law Offices

汉坤 • 观点 | 细胞与基因治疗领域又一利好：研究者发起的临床研究（IIT）管理办法正式落地

China Healthcare

HK

Han Kun Law Offices

汉坤 • 观点 | 解读2024年版《赫尔辛基宣言》最新亮点 — 全球医学研究伦理准则系统性更新

China Healthcare

HK

Han Kun Law Offices

观点 | 《医疗器械管理法（草案）》十大亮点快评

China Healthcare

HK

Han Kun Law Offices

China Released Draft Medical Device Law For Comments

China Healthcare

HK

Han Kun Law Offices

Key Takeaways on China's Pilot Plan for Segmented Production of Biological Products

China Healthcare

HK

Han Kun Law Offices

China Pilots Lifting Restrictions On Foreign Investment In Stem Cell, Gene Therapy, And Genetic Diagnosis Sectors In Four Free Trade Zones

China Healthcare

HK

Han Kun Law Offices

速评《美国优先投资政策备忘录》对中国生物医药行业的潜在影响

China Government

HK

Han Kun Law Offices

观点 | 中美关税博弈对医药行业的影响快评

China International

HK

Han Kun Law Offices

解读人类遗传资源管理最新问答：人源细胞系、肿瘤异种移植模型（CDX/PDX）、CAR-T治疗材料监管问题

China Healthcare

HK

Han Kun Law Offices

Patent Protection Via Judicial Relief, China Patent System VI

AC

AFD China

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