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Article
Revisions Of The Implementing Regulations Of The Patent Law And The Patent Examination Guidelines: Comments On Several Key Issues
The fourth revision of the Chinese Patent Law (Revised in 2020) came into effect on June 1, 2021. About two and a half years later, the accompanying revised Implementing Regulations of the Patent Law...
ChinaIntellectual Property
Lung Tin IP Attorneys
Article
对《最高人民法院知识产权法庭裁判要旨摘要（2023）》所涉药品专利链接诉讼案件的解读（一）
《专利法》第七十六条、《药品专利纠纷早期解决机制实施办法（试行）》（简称药品专利纠纷实施办法）和《最高人民法院关于审理申请注
ChinaFood, Drugs, Healthcare, Life Sciences
AnJie Broad Law Firm

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...

ChinaFood, Drugs, Healthcare, Life Sciences

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...

ChinaFood, Drugs, Healthcare, Life Sciences

Han Kun Law Offices

观点 | 中美关税博弈对医药行业的影响快评

此外，由于中国反制措施没有提供针对医药行业的特定豁免，预计未来一段时间内美国进口药价格将会持续走高，对此应当做好全面的准备。

ChinaInternational Law

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

License-in/out is a common transaction model in the pharmaceutical field in recent years, that is, the licensor licensees the relevant R&D technology and patents...

ChinaFood, Drugs, Healthcare, Life Sciences

Han Kun Law Offices

智能器械系列(三) 手术机器人商业化与智能化的法律问题初探

手术机器人，一度被称为刀尖上的科技革新。

ChinaFood, Drugs, Healthcare, Life Sciences

AnJie Broad Law Firm

市场监管领域过罚相当原则的适用与裁判

行政处罚必须遵循过罚相当原则，既要适用部门法的具体规定...

ChinaGovernment, Public Sector

Jincheng Tongda & Neal

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.

ChinaFood, Drugs, Healthcare, Life Sciences

Han Kun Law Offices

《专利法实施细则》修改内容速报！

2023年12月21日，修订后的《专利法实施细则》公布，并将于2024年1月20日起施行，现摘录汇总修订内容以供初步参考。

ChinaIntellectual Property

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

ChinaFood, Drugs, Healthcare, Life Sciences

Han Kun Law Offices

Interpretation Of The Anti-Monopoly Guidelines For Pharmaceutical Sector: Key Risk Considerations

On January 23, 2025, the Anti-Monopoly and Anti-Unfair Competition Commission under China's State Council officially released the PRCAnti-Monopoly Guidelines for the Pharmaceutical Sector...

ChinaFood, Drugs, Healthcare, Life Sciences

AnJie Broad Law Firm

医药制剂领域反垄断风险升级：从"卡莫司汀注射液案"说起

在2022年《反垄断法》修订之后，业界对于反垄断执法机构的行政处罚格外关注。2023年3月14日，天津市市场监督管理委员会（"天津市监委"）对天津金

ChinaAntitrust/Competition Law

AnJie Broad Law Firm

AFD China Newsletter - July, 2025

Under the joint witness of Chinese President Xi Jinping and Kazakh President Kassym-Jomart Tokayev, the China National Intellectual...

ChinaIntellectual Property

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...

ChinaFood, Drugs, Healthcare, Life Sciences

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

On December 1, 2019, the Drug Administration Law and the Vaccine Administration Law officially came into effect, and the relevant regulations adjusted the management...

ChinaFood, Drugs, Healthcare, Life Sciences

Han Kun Law Offices

药品领域反垄断指南征求意见稿出台，有哪些亮点值得医药企业关注？

2024年8月9日，市场监管总局发布了《关于药品领域的反垄断指南（征求意见稿）》（以下简称《药品反垄断指南》或《指南》），向社会公开征૓

ChinaAntitrust/Competition Law

Chance Bridge Law Firm

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

ChinaFood, Drugs, Healthcare, Life Sciences

Han Kun Law Offices

药品许可交易概览及核心法律条款

自我国实施药品上市许可持有人（MAH）制度以来，药品上市许可与生产许可实现了分离管理，使得在药品生产方面实力不足的轻资产型药品研发&

ChinaFood, Drugs, Healthcare, Life Sciences

AnJie Broad Law Firm

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</strong>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

ChinaFood, Drugs, Healthcare, Life Sciences

Han Kun Law Offices

Showing 441–460 of 483 results

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