China: Food and Drugs Law

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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.

Extract Of Annual Report On Issues Of Law Application By Nationwide Courts In IP Cases (2024)

On April 21, 2025, the Supreme People's Court (SPC) released the Annual Report on the Issues of Law Application in intellectual property (IP) cases...

PP

Panawell & Partners

艾睿铂发布2026年全球消费者展望：经济不确定性将持续加深节俭趋势，重塑全球消费优先级

调研表明全球高收入人群及中国消费者正在削减支出

A

AlixPartners

Understanding China's Pharmaceuticals Patent Linkage System: Judicial Trends And Key Takeaways From Recent Cases (Part 2)

In the first article of this series, we elaborated on the regulatory framework of the Pharmaceuticals patent linkage system of China, along with the current status of case acceptance, applicable conditions...

CT

Chang Tsi & Partners

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

In recent years, China's regulatory framework for human genetic resources has matured. Regulatory authorities have issued and updated a series of legal documents...

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

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

Starbucks Brews A New Chapter In China

MC

Marks & Clerk

以案说法：拆解申请香港资产冻结令协助内地民商事判决在港执行的条件

China Commercial

JT

Beijing Jincheng Tongda & Neal Law Firm

专利审查中引入跨领域知识作为公知常识的几点思考

CP

CCPIT Patent & Trademark Law Office

医药健康企业融资谈判过程中需要创始人注意的两三事（上篇）

China Healthcare

JT

Beijing Jincheng Tongda & Neal Law Firm

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

Shaohe & Benelux Chamber: A Partnership That Empowers Talent (Video)

China Law Performance

SL

Shaohe 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

中国标准必要专利 (SEP) 实践面临世界贸易组织（WTO）挑战

R

Rouse

This Is (Still) China (Video)

China Commercial

HS

Harris Sliwoski

Asia's Capital Is On The Move: The View From Australia And Singapore (Podcast)

Worldwide Strategy

KW

King & Wood Mallesons

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

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。

China Healthcare

HK

Han Kun Law Offices

Han Kun • Opinion | Hot Spot Tracking: Daily Regulatory Risk Warnings For Drug Clinical Trial Institutions

Recently, it was rumored on the Internet that the Department of Drug Registration Management of the State Medical Products Administration issued the "Letter on Strengthening the Daily Supervision...

China Healthcare

HK

Han Kun Law Offices

Han Kun • Opinion | Interpretation Of China's Annual Drug Review Report (2015-2021) - Review Of The Achievements Of Our Country's Drug Review And Approval System Reform (Part 1)

China Healthcare

HK

Han Kun Law Offices

Han Kun • Opinion | Interpretation Of The "Detailed Rules For The Supervision Of Internet Diagnosis And Treatment (Trial)"

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 | Research On Urban Customized Commercial Medical Insurance

China Insurance

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

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

"不竞争条款（Non-Compete Clause）"是License-in/out交易中保障技术价值、

China Healthcare

HK

Han Kun Law Offices

2024 Data Analytics: China Life Sciences NewCo & Licensing Terms

License-in/out transactions have become a key strategic approach for innovative drug and medical device (including medical aesthetics) companies to expedite the research and development of the products and expand market presence.

China Healthcare

HK

Han Kun Law Offices

Strengthening Oversight of Imported Drugs: Key Takeaways into New Regulations on Domestic Responsible Entities

China Healthcare

HK

Han Kun Law Offices

Han Kun • Opinion | Implementation And Regulation Of DCT (Decentralized Clinical Trials) In China

The concept of "patient-centered" has become the core guiding ideology of current drug development. "Patient-centered" drug development refers to the process...

China Healthcare

HK

Han Kun Law Offices

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

In recent years, an increasing number of multinational pharmaceutical and medical device companies have been exploring local manufacturing options in China.

China Healthcare

HK

Han Kun Law Offices

汉坤 • 观点 | LDT试点新规解读

近年来，我国不断探索对LDT的监管。随着一系列新规的出台，有众多优秀的跨国及本土公司均参与到该领域的研究中...

China Healthcare

HK

Han Kun Law Offices

Han Kun • Opinion | The Spring Of Traditional Chinese Medicine? From The "Special Provisions On The Registration And Administration Of Traditional Chinese Medicines", The Characteristic Marketing Evaluation System Of Traditional Chinese Medicine

In recent years, our country has been vigorously supporting the inheritance, innovation and development of traditional Chinese medicine. In 2019...

China Healthcare

HK

Han Kun Law Offices

Analysis Of China's New Draft Of Drug Regulatory Data Protection Rule: A New Perspective On Innovative Drug Transactions

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

2024年専利復審・無効審判の典型事例判決要点集（二）

K

Kangxin

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 | Interpret The New Regulations For The Inspection Of Drug Clinical Trial Institutions In The Post-"722 Storm" Era

China Healthcare

HK

Han Kun Law Offices

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

China Healthcare

HK

Han Kun Law Offices

Han Kun • Opinion | Quick Review Of The New Regulations: Interpret The Latest Questions And Answers Of The Ministry Of Science And Technology

China Healthcare

HK

Han Kun Law Offices

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

China Healthcare

HK

Han Kun Law Offices

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

China Healthcare

HK

Han Kun Law Offices

Hankun • Quick Comment | The Regulations On Human Genetic Resources Management Are Revised Again

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

China Healthcare

HK

Han Kun Law Offices

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