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.

Thin Disclosure But "Bulletproof" Protection: How A Salt Form Patent Was Upheld In China Despite Minimal Data

In China, innovative drug companies typically rely on their initial composition of matter patents to block out competitors.

EI

Eagle IP

商标不使用撤销制度中"不使用的正当理由"的内涵浅析

随着国家知识产权局对商标近似认定标准的从严规制，商标不使用撤销（简称"撤三"）案件申请量近三年呈现爆发式增长态势：2022年为15万件，2023年增!

CP

CCPIT Patent & Trademark Law Office

如何为"已知物质"的新医药用途争取专利保护？ ——中国审查实务深度解析与策略指南

药物的研发具有周期长、投入高、风险大、技术难度高的显著特点。

CP

CCPIT Patent & Trademark Law Office

China Newsletter | Q3 2025/Issue No. 65

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

GT

Greenberg Traurig, LLP

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

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

A

AlixPartners

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

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

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

新《监察法》与《监察法实施条例》修订综述——授权与控权平衡中的监察体系建构

JT

Beijing Jincheng Tongda & Neal Law Firm

外卖平台合规与骑手权益保护：新国标GB/T 46862-2025的劳动法解读

China Employment

JT

Beijing Jincheng Tongda & Neal Law Firm

Beyond Stay Or Leave: How MNCs Are Recalibrating Their China Strategy (Video)

China Commercial

AM

Alvarez & Marsal

中国标准必要专利 (SEP) 实践面临世界贸易组织（WTO）挑战

R

Rouse

香港法院最新判决：除非存在反制因素，仲裁条款可阻碍清盘程序

China Litigation

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

在关于发明申请的专利实质审查实践中，审查员有时需要对最接近的现有技术和"本领域的公知常识"进行结合来评述创造性。当这种结合超越了发਴

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）

近两年，因为生物医药类企业IPO承压...

China Healthcare

JT

Beijing Jincheng Tongda & Neal Law Firm

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

汉坤 • 观点 | 简评新版《医疗器械临床试验质量管理规范（GCP）》

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 | Hot Spot Tracking: Daily Regulatory Risk Warnings For Drug Clinical Trial Institutions

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

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...

China Healthcare

HK

Han Kun Law Offices

Han Kun • Opinion | Research On Urban Customized Commercial Medical Insurance

In order to promote the construction of a healthy China, our country has continuously strengthened the top-level design of the universal medical security system.

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)

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"？

China Healthcare

HK

Han Kun Law Offices

First Drug Patent Term Extension Granted In China

With the information from Chenghua Luo of Amgen , which is highly appreciated, I write to report on the first drug patent term extension (DPTE) granted in China. Please correct me if anyone is aware of another DPTE granted in China earlier.

TM

Toby Mak

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...

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

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

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 | Implementation And Regulation Of DCT (Decentralized Clinical Trials) In China

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 | 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

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

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