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.

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

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

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

China's New AI Labeling Rules: What Every China Business Needs To Know

China Technology

HS

Harris Sliwoski

Critical Insecurity – How Critical Minerals Policies Are Impacting Global Markets And Supply Chains

China International

KW

King & Wood Mallesons

当AI工具把"路标"指向平台，这场博弈谁输谁赢

China Technology

JT

Beijing Jincheng Tongda & Neal Law Firm

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

反不正当竞争法修订要点解读

AC

AFD China

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

In the upcoming 2023, the life sciences and medical health fields have ushered in many developments and have become the basic core areas related to national security...

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

On September 8, 2023, the China Biotechnology Development Center directly under the Ministry of Science and Technology of the People's Republic of China...

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

Recently, U.S. President Joe Biden signed the Executive Order on Preventing Access to Americans' Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern) ("Executive Order").

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

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

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

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

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

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

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

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

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

China Healthcare

HK

Han Kun Law Offices

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

Based on our experience, many projects that consider multiple factors and make separate arrangements for econo

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

被许可方认为，适应症变更会在很大程度上浪费先前在适应症X上的研发投入。适应症变更后，许多临床前研究需要重做，也需要重新进行IND申

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

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

Recently, the National Medical Products Administration (the "NMPA") issued the "Pilot Work Plan for Segmented Production of Biological Products" (the "Pilot Plan"), introducing the pilot initiative for the 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

On September 8, 2024, the Ministry of Commerce, together with the National Health Commission and the National Medical Products Administration (hereinafter referred to as the "Three Departments"), publicly issued the Notice on Carrying Out Pilot Programs to Expand Opening-Up in the Healthcare Sector (hereinafter referred to as the "Notice")...

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

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

当地时间2025年2月21日，美国总统特朗普发布了一份名为《美国优先投资政策》（America First Investment Policy）的备忘录（"备忘录"）

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

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

Compliance Highlights And Strategies In High-Risk Clinical Research Landscape

China Healthcare

HK

Han Kun Law Offices

Patent Protection Via Judicial Relief, China Patent System VI

AC

AFD China

特許登録件数が世界1位を維持　中国のナノテクノロジー産業が急成長

K

Kangxin

Six Key Insights Into China Biotech's NewCo Model

China Healthcare

HK

Han Kun Law Offices

Industry Observation｜China Life Sciences And Healthcare Weekly Report No. 30

China Healthcare

SG

SGLA Law Firm

What Are The Contract Essentials For China-related Life Sciences Collaboration Agreements?

Worldwide Healthcare

GW

Gowling WLG

China On The Move: China's Healthcare And Life Sciences Regulatory Evolution In 2025

China Healthcare

GT

Greenberg Traurig, LLP

China Compliance Update – Summer 2025

AP

Arnold & Porter

A Brief Discussion On Biological Preservation And The Patentability Of Patent Applications Under Chinese Patent Law

K

Kangxin

The Regulatory Data Protection Regime In China (Draft For Comments)

China Healthcare

FP

Fangda Partners

Growth and Opportunities in China's Medical Device Market.

China Healthcare

A

Acclime

揭秘中国创新药企NewCo模式实战中的"六脉神剑"

China Healthcare

HK

Han Kun Law Offices

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