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ArticleDraft For Soliciting Opinions On The Anti-Monopoly Guidelines In The Pharmaceutical Sector Released: Key Highlights For Pharmaceutical CompaniesOn August 9, 2024, the State Administration for Market Regulation (SAMR) released the Anti-Monopoly Guidelines for the Pharmaceutical Sector (Draft for Public Comment) (hereinafter referred to as the Pharmaceutical Anti-Monopoly Guidelines or the Guidelines) to solicit opinions from the public.ChinaAntitrust/Competition Law
ArticleThird Revision Of The "Implementing Regulations Of The Patent Law Of The People's Republic Of China" – Reexamination And InvalidationIn order to ensure the effective implementation of the newly revised Patent Law, further improve China's patent protection system, and align with relevant international rules, ...ChinaIntellectual PropertyAFD China
ArticleHan Kun Opinion | CAR-T/NK Regulatory Decisions — Interpreting The "Guidelines For Somatic Cell Clinical Research (Trial)"On August 18, 2023, the China Medical Biotechnology Association (CMBA), commissioned by the Department of Science and Technology of the National Health Commission (" NHC ")...ChinaFood, Drugs, Healthcare, Life SciencesHan Kun Law Offices
ArticleHan Kun • Quick Comment | Is The Transmission Of Cross-border Genomic Data Between China And The United States Blocked? Biden Data Executive Order Quick ReviewRecently, 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").ChinaFood, Drugs, Healthcare, Life SciencesHan Kun Law Offices
ArticleTen Minefields: A Guide To Avoiding Pitfalls In Applying For Human Genetic Resources Projects In ChinaIn recent years, China's regulatory framework for human genetic resources has matured. Regulatory authorities have issued and updated a series of legal documents...ChinaFood, Drugs, Healthcare, Life SciencesHan Kun Law Offices
Article制药企业驰名商标保护相关问题-兼评"赛诺菲""SANOFI"驰名商标行政诉讼案件企业的品牌经过长期使用在市场上具有较高知名度的情况下,他人恶意摹仿和搭便车等不正当行为亦伴随而生。权利人必然希望能够采取各种ChinaIntellectual PropertyRouse
Article中国创新药械全球崛起法律保障系列文章之一:创新药研发企业临床试验数据对外跨境传输的监管要点得益于药品上市许可持有人制度确立、药品审评审批制度改革、专利链接制度...ChinaPrivacyAnJie Broad Law Firm
Article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2023年10月8日,中华人民共和国科学技术部("科技部")会同教育部、工业和信息化部等十个部门与机构共同发布了《科技伦理审查办法(试行)》ChinaFood, Drugs, Healthcare, Life SciencesHan Kun Law Offices
ArticleHan Kun • Opinion | Key Points For The Supervision Of Medical And Three-Product And One-Device Advertising Under The New Regulations On Internet AdvertisingOn March 24, 2023, the State Administration for Market Regulation publicly issued the "Measures for the Administration of Internet Advertising" (the "Measures")...ChinaFood, Drugs, Healthcare, Life SciencesHan Kun Law Offices
ArticleExamination Practice Of Antibody-Related Patent Applications In ChinaRegarding the new matter issue, the examiners take more stringent standards in practice. ChinaIntellectual PropertyLiu Shen & Associates
Article医药企业申请商标的注意事项医药行业是我国国民经济的重要组成部分。近年来,随着国民健康意识的提升和医疗保险覆盖的完善,医药行业得以快速发展。大批医药企业ChinaIntellectual PropertyCCPIT Patent and Trademark Law Office
Article新特許法改正点概要2020年10月17日、第四次特許法改正案が全国人民代表大会常務委員会の審議で通過し、2021年6月1日から施行することになりました。ChinaIntellectual PropertyKangxin
ArticleHan 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...ChinaFood, Drugs, Healthcare, Life SciencesHan Kun Law Offices
Article对药品专利权期限补偿的解析和思考在过去数年中,我国医药行业发展迅速,已成为全球最大、最活跃的医药市场之一。为了进一步鼓励药品研发创新...ChinaIntellectual PropertyCCPIT Patent and Trademark Law Office
ArticleChina Amends The Patent Law: A Stronger Protection Is On The WayChina's top legislature, Standing Committee of the National People's Congress (SCNPC), adopted the 4th Amendment of the China Patent Law on October 17, 2020 and the Amendment shall become effective as of June 1, 2021. ChinaIntellectual PropertyCCPIT Patent and Trademark Law Office
ArticleHan Kun • Opinion | 2023 Life Sciences Regulatory Compliance Annual SummaryIn 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...ChinaFood, Drugs, Healthcare, Life SciencesHan Kun Law Offices
Article新法速评 — 2022年《药品召回管理办法》要点解读2022年10月26日,国家药监局发布了刚刚正式通过的新《药品召回管理办法》(下称新《办法》)。我国现行《药品召回管理办法》于2007年12月10日公布ChinaFood, Drugs, Healthcare, Life SciencesHan Kun Law Offices
Article2020 Amendments To The Chinese Patent LawOn October 17, 2020, Xi Jinping, President of the People's Republic of China, issued Presidential Decree No. 55, announcing the "Decision of the Standing Committee of the National People's Congress on ...ChinaIntellectual PropertyAFD China
Article《关于药品领域的反垄断指南》解读:药企反垄断风险"划重点"2025年1月23日,国务院反垄断反不正当竞争委员会正式发布了《关于药品领域的反垄断指南》("《指南》正式稿")。从2024年8月9日发布征求意见稿到2025&ChinaFood, Drugs, Healthcare, Life SciencesAnJie Broad Law Firm