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.

China's New Regulatory Data Protection Regime Becomes Effective Immediately

China's National Medical Products Administration has introduced a groundbreaking regulatory data protection framework that grants up to six years of clinical data exclusivity for pharmaceuticals.

China Healthcare

JD

Jones Day

Breaking: China Released Drug Trial Data Protection Implementation Measures

China's National Medical Products Administration has finalized groundbreaking regulatory data protection measures that grant up to 6 years of market exclusivity for innovative drugs, fundamentally...

China Healthcare

EI

Eagle IP

国家知识产权局发布2025年度专利复审无效典型案例

近日，国家知识产权局遴选出十件关注度高、影响力大、具备指导价值的2025年度专利复审无效典型案例，以深入阐释专利审查标准，明晰专利保护规则...

AC

AFD China

China Releases 2025 Typical Cases On Patent Reexamination And Invalidation

China's national intellectual property administration (CNIPA) has released ten typical cases from 2025 involving patent reexamination and invalidation. These cases were selected because they are highly relevant...

AC

AFD China

China Compliance Update: Life Sciences — Spring 2026

China Healthcare

AP

Arnold & Porter

SRS v. Alexion药品许可诉讼案评析——兼论中国创新药企BD合同的风险防控与条款设计

China Commercial

JT

Beijing Jincheng Tongda & Neal Law Firm

Judicial Assessment Of Usage Limitations' Impact On The Novelty Of Product Claims

AC

AFD China

外資の研究開発投資が拡大　中国、世界のイノベーション拠点

China Government

K

Kangxin

A Stratification Too Far? How The CNIPA Draws The Line On Patient Subgroups In A Recent Precision Medicine Invalidation Case

EI

Eagle IP

China’s Pharma Innovators Pursue A Range Of Deal Structures To Support Global Expansion

China Healthcare

AO

A&O Shearman

China Compliance Update: Life Sciences — Spring 2026

China Healthcare

AP

Arnold & Porter

ライブ販売の商標侵害に厳罰山東高裁、懲罰的賠償で抑止強化

K

Kangxin

世界初の「動画MRI」実用化　中国企業、AI技術でリアルタイム撮影

K

Kangxin

USITC Will Investigate State Support And Pricing Practices By Chinese Biotechnology Firms

China Healthcare

BC

Bergeson & Campbell

Two Regulations, One Direction: China’s Expanding Economic Security Playbook

China International

SJ

Steptoe LLP

海关法领域2025年政策回顾与2026年展望：出口管制、关税及企业应对

China International

AB

AnJie Broad Law Firm

信用证下倒签与顺签及重复签发纸质提单和电放提单（surendered Bills Of Lading）的法律后果：浙江省高级人民法院二审"宁波南衡进出口有限公司与株式会社新韩银行信用证纠纷案"判决书简述与点评

China Commercial

JT

Beijing Jincheng Tongda & Neal Law Firm

红筹架构迎严监管：企业赴港上市前拆除红筹的实践路径探析

China Commercial

JT

Beijing Jincheng Tongda & Neal Law Firm

AI 不雅影像黑产刑事风险解析与受害人维权指引

China Technology

JT

Beijing Jincheng Tongda & Neal Law Firm

China Life Sciences: 2025 Year In Review

2025 was a year of notable developments for China's life sciences industry, marked by significant revisions to major legislation and regulations.

China Healthcare

AP

Arnold & Porter

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...

China Media & IT

FP

Fangda Partners

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")...

China Healthcare

FP

Fangda Partners

China Newsletter | Q3 2025/Issue No. 65

This China Newsletter provides an overview of key developments in the following areas...

GT

Greenberg Traurig, LLP

Navigating China's Health Transformation: Opportunities And Challenges For Multinationals

China Healthcare

AC

Ankura Consulting Group LLC

Tips For Pharmaceutical Use Claims

CT

Chang Tsi & Partners

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

China Healthcare

HK

Han Kun Law Offices

China Released Draft Medical Device Law For Comments

China Healthcare

HK

Han Kun Law Offices

Understanding China's Pharmaceutical Patent Linkage System: Framework And Case Overview (Part 1)

CT

Chang Tsi & Partners

生物医药领域符合WIPO标准ST.26的序列表制作经验

CP

CCPIT Patent & Trademark Law Office

China Life Sciences Compliance Update: Insurance Fraud Enforcement Campaign And New Ethical Code For HCPs

China Healthcare

AP

Arnold & Porter

China Life Sciences Compliance Update: Kickback And Third-Party Case Study

China Healthcare

AP

Arnold & Porter

Understanding The EU's International Procurement Instrument

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

China Healthcare

HK

Han Kun Law Offices

China Life Sciences Compliance Update: Insurance Fraud Enforcement Campaign And New Ethical Code For HCPs

Chinese authorities have launched a special "Hundred-Day Campaign" to target misconduct relating to China's state-run medical insurance program and issued a new Ethical Code for Healthcare Professionals...

China Healthcare

AP

Arnold & Porter

China Life Sciences Compliance Update: Kickback And Third-Party Case Study

A recent criminal judgment published by the Gao'an People's Court in Jiangxi province (江西省高安市人民法院) in June 2025 has drawn public attention to Jiangxi Baishen Pharmaceutical Co.

China Healthcare

AP

Arnold & Porter

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

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)

In "Interpretation of China's Annual Drug Review Report (2015-2021) - Review of the Achievements of China's Drug Review and Approval System Reform (Part 1)"...

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)

In the "Interpretation of China's Annual Drug Evaluation Report (2015-2021) - Review of the Achievements of China's Drug Evaluation and Approval System Reform (Part 1)", we have summarized and refined the key contents...

China Healthcare

HK

Han Kun Law Offices

汉坤 • 观点 | 医药BD项目如何友好"分手"？

医药BD(business development，商务拓展)项目通常指通过授权许可、投资、并购、合作开发/商业化等方式进行产品和技术的商业机会拓展。全球新冠疫情已逾三年，

China Healthcare

HK

Han Kun Law Offices

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

This article discusses the regulation of DTx products in China, the question of registration, and best practices for collecting and processing data through DTx products.

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

Han Kun • Opinion | Key Points For The Supervision Of Medical And Three-Product And One-Device Advertising Under The New Regulations On Internet Advertising

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)

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

China Healthcare

HK

Han Kun Law Offices

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

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

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