Traditional Chinese Medicine Knowledge Protection: What the September 2026 Draft Regulation Means for Foreign Pharmaceutical and Healthcare Companies
- On 18 September 2026, the State Council executive meeting reviewed and approved in principle the Draft Regulation on the Protection of Traditional Chinese Medicine Knowledge, describing traditional Chinese medicine theory, techniques and formulas as important resources for China’s own innovation and calling for comprehensive strengthening of protection and management.
2026年9月18日，国务院常务会议审议通过《中医药传统知识保护条例（草案）》，会议指出中医药理论、技术和方药是我国自主创新的重要资源，要全面加强保护管理。
- The regulation is to establish a protection system for traditional Chinese medicine knowledge: after registration and review-based recognition, a holder enjoys rights to indicate identity, to transmit and use, to informed consent, to benefit sharing, to integrity protection and to require disclosure of source, while medical institutions are encouraged to proactively investigate and develop proven formulas, secret formulas and techniques.
条例将建立中医药传统知识保护制度：经登记并审核认定后，持有人享有表明身份、传承使用、知情同意、利益分享、完整保护、要求说明来源等权利，并鼓励医疗机构主动调查发现中医药验方、秘方和技法并进行开发研究。
- The draft has not been published in full, so no article numbers, effective date, registration procedure or recognition thresholds are available; planning should rest on the official record as it appears.
草案尚未公布全文，条款编号、生效日期、登记程序与认定门槛均无从确认；相关规划应以官方后续发布为准。
- The IP Protection and Application 15th Five-Year Plan (State Council document No. 30 of 2026, issued on 27 July 2026) already lists “issuing the Regulation on the Protection of Traditional Chinese Medicine Knowledge” and strengthening access and benefit-sharing systems for traditional knowledge and folk literature and art.
《知识产权保护和运用”十五五”规划》（国发〔2026〕30号，国务院2026年7月27日印发）已明确”出台中医药传统知识保护条例”，并加强传统知识、民间文艺等获取和惠益分享制度建设。
- The same Plan directs improvement of intellectual property protection rules for algorithms and AI-generated output and exploration of data intellectual property protection rules, matters relevant to digital health and AI-assisted research.
同一规划还提出完善算法、人工智能生成物等知识产权保护规则，探索构建数据知识产权保护规则，与数字健康及人工智能辅助研究密切相关。
- The revised Trademark Law was adopted on 26 June 2026 and takes effect on 1 January 2027; it writes the principle of good faith into the law and targets bad-faith filings, trademark hoarding and agency conduct.
新修订《商标法》于2026年6月26日通过、2027年1月1日施行，将诚实信用原则写入法律，并针对恶意抢注、商标囤积及代理行为作出规范。
Traditional Chinese Medicine Knowledge Protection: What the September 2026 Draft Regulation Means for Foreign Pharmaceutical and Healthcare Companies | 中医药传统知识保护：2026年9月国务院常务会议审议通过条例草案对外资医药与大健康企业的意义
Overview
On 18 September 2026, the State Council executive meeting reviewed and approved in principle the Draft Regulation on the Protection of Traditional Chinese Medicine Knowledge. In the official account, traditional Chinese medicine theory, techniques and formulas are described as important resources for China’s own innovation, and the requirement is to comprehensively strengthen their protection and management. The draft has not yet been published in full.
For foreign pharmaceutical, healthcare and wellness companies working in or with China, the development matters for a practical reason. It sits alongside a wider set of intellectual property measures that took effect or moved through the system in 2026, from the revised Trademark Law to the IP Protection and Application 15th Five-Year Plan. Together they shape how traditional knowledge, research collaboration and brand assets are documented and defended.
This article sets out the official wording, the protection system as described, the institutional arrangements in the 15th Five-Year Plan, and the practical points foreign companies may wish to consider. It deliberately does not speculate beyond the official record.
The September 2026 decision
The executive meeting approved the draft and set the direction of policy. Traditional Chinese medicine theory, techniques and formulas are treated as important resources for China’s own innovation, and the task set is to comprehensively strengthen protection and management.
The regulation is to establish a protection system for traditional Chinese medicine knowledge. Under that system, after registration and review-based recognition, a holder enjoys a set of rights: to indicate identity, to transmit and use the knowledge, to give informed consent, to share in benefits, to integrity protection, and to require disclosure of source.
The official account also encourages medical institutions to proactively investigate and discover traditional Chinese medicine proven formulas, secret formulas and techniques, and to carry out development and research on them.
Because the full text has not been published, no article numbers, effective date, registration procedure or definitional thresholds are available. Companies should treat any such details as pending until an official release appears, and should not rely on descriptions that circulate without an official source.
What the 15th Five-Year Plan already provides
The draft regulation is not an isolated initiative. The IP Protection and Application 15th Five-Year Plan (State Council document No. 30 of 2026, issued on 27 July 2026) had already placed it within a wider programme.
The Plan calls for accelerating improvement of the patent-related legal system, for comprehensively revising the Trademark Law and its implementing regulations, and for issuing the Regulation on the Protection of Traditional Chinese Medicine Knowledge. It also directs strengthening access and benefit-sharing systems for traditional knowledge, folk literature and art, and improving intellectual property protection rules for algorithms and AI-generated output as well as for platform-economy development. It further calls for exploring data intellectual property protection rules.
The Plan sets out milestones. By 2030, China’s comprehensive intellectual property strength and international competitiveness are to be further enhanced, with decisive progress in building an intellectual property power. Looking to 2035, comprehensive intellectual property competitiveness is to rank among the world’s leading.
For a company mapping its China research and brand strategy, the Plan is useful because it shows the direction of travel across several instruments at once rather than the detail of a single new rule.
Adjacent intellectual property developments in 2026
A nationwide briefing tour on new intellectual property rules began in Jinan on 20 September 2026, covering the Shandong and Anhui region. The briefings addressed three instruments.
The revised Trademark Law writes the principle of good faith into the law, targets bad-faith filings and the hoarding of trademarks, tightens supervision of trademark agencies and strengthens industry credit constraints. It was adopted on 26 June 2026 and takes effect on 1 January 2027.
The revised Regulation on the Protection of Layout Designs of Integrated Circuits brings layout designs performing functions such as integrated photonics and quantum into the statutory scope of protection and establishes an originality declaration system.
The revised Measures for the Prioritised Examination of Patents steer prioritised examination resources toward emerging industries and key core technology programmes, and establish a central-local coordination mechanism.
Read together with the traditional knowledge regulation, these measures point in a consistent direction: more explicit documentation of what is claimed, who holds it and where it came from.
Practical implications for foreign pharmaceutical and healthcare companies
Due diligence on traditional knowledge. Where a project touches formulas, techniques or sources of traditional knowledge, the rights described in the official account — identity, transmission and use, informed consent, benefit sharing, integrity protection and disclosure of source — suggest that provenance and consent questions may become part of the record. Companies may wish to document how a formula or technique was obtained and on what terms.
Collaboration agreements. Research with hospitals, institutes and practitioners should be documented, with clarity on background and foreground rights, on publication, and on how jointly created results are handled.
Patent and brand layout. The Plan’s direction on patents and the revised Trademark Law both reward early, well-documented filing strategies. A portfolio that depends on distinctive names and marks should be checked against the good-faith and bad-faith filing provisions as they take effect.
Digital and AI-related work. The Plan’s references to algorithms, AI-generated output and data intellectual property are relevant to digital health, AI-assisted screening and data-driven research, where ownership of outputs and datasets is often unsettled.
Watch the official record. Because the draft regulation is not yet published in full, the specific registration route, recognition criteria and benefit-sharing mechanics remain to be seen. Planning should be revisited when the text and any supporting measures are released.
Related considerations
Foreign-invested companies in the healthcare and wellness sectors already work within sector-specific rules on drugs, devices, healthcare services and advertising. The traditional knowledge regulation adds a knowledge-protection layer rather than replacing those rules. Keeping the two layers distinct — what may be made and sold, and what knowledge may be used and on what terms — helps avoid conflating a licensing question with a market-access question.
Sources
- 国家知识产权局（《知识产权保护和运用”十五五”规划》专栏）: https://www.cnipa.gov.cn/col/col3692/index.html
- 酒泉市公安局（《知识产权保护和运用”十五五”规划》国发〔2026〕30号全文转载）: https://gaj.jiuquan.gov.cn/gaj/c106483/202609/856895252998428d9990e67d9af39108.shtml
- 国家知识产权局（官网，9月工作动态）: https://www.cnipa.gov.cn/?filter=0
- 大众网滨州（知识产权新规全国巡回宣贯，9月20日济南，9-23）: https://www.toutiao.com/article/7688564714451780098/
- 中国政府网: https://www.gov.cn/
中医药传统知识保护：2026年9月国务院常务会议审议通过条例草案对外资医药与大健康企业的意义
概述
2026年9月18日，国务院常务会议审议通过《中医药传统知识保护条例（草案）》。官方表述指出，中医药理论、技术和方药是我国自主创新的重要资源，要全面加强保护管理。该草案尚未公布全文。
对在华开展业务或与中国合作的外资医药、医疗健康与大健康企业而言，这一进展具有现实意义：它与2026年已经施行或正在推进的一揽子知识产权举措并列，从新修订《商标法》到《知识产权保护和运用”十五五”规划》，共同影响传统知识、研究协作与品牌资产的记录与维护方式。
本文梳理官方原文表述、条例拟确立的保护制度、规划中的制度安排，以及外资企业可能关注的实务要点，并刻意不作出超出官方记录范围的推断。
2026年9月的决定
国务院常务会议审议通过草案并确定了政策方向。中医药理论、技术和方药被视为我国自主创新的重要资源，任务要求是全面加强保护管理。
条例将建立中医药传统知识保护制度。在该制度下，经登记并审核认定后，持有人享有一组权利：表明身份、传承使用、知情同意、利益分享、完整保护、要求说明来源。
官方表述还鼓励医疗机构主动调查发现中医药验方、秘方和技法，并进行开发研究。
由于全文尚未公布，条款编号、生效日期、登记程序与认定门槛均无从确认。企业宜将此类细节视为待定，直至官方发布为止，不应依赖没有官方出处的描述。
“十五五”规划已作出的安排
该条例草案并非孤立举措。《知识产权保护和运用”十五五”规划》（国发〔2026〕30号，国务院2026年7月27日印发）已把它纳入更宏大的部署。
规划提出加快完善专利相关法律制度，推动商标法及其实施条例全面修改，并出台中医药传统知识保护条例。规划还提出加强传统知识、民间文艺等获取和惠益分享制度建设，完善算法、人工智能生成物以及与平台经济发展相关的知识产权保护规则，并探索构建数据知识产权保护规则。
规划设定了节点目标：到2030年，知识产权综合实力和国际竞争力进一步增强，知识产权强国建设取得决定性进展；展望2035年，知识产权综合竞争力跻身世界前列。
对正在规划中国研究与品牌战略的企业而言，该规划的价值在于，它一次性展示了多项制度工具的共同走向，而不只是一条新规的细节。
2026年相邻的知识产权进展
2026年9月20日，知识产权新规全国巡回宣贯在济南启动，覆盖山东、安徽片区。宣贯围绕三件法规展开。
新修订《商标法》将诚实信用原则写入法律，遏制恶意抢注、囤积商标，严格商标代理监管，强化行业信用约束。该法于2026年6月26日通过，2027年1月1日施行。
新修订《集成电路布图设计保护条例》将集成光子、量子等功能的集成电路布图设计纳入法定保护范围，并建立独创性声明制度。
修订后的《专利优先审查管理办法》使优先审查资源向新兴产业、关键核心技术攻关倾斜，并建立央地协同机制。
与中医药传统知识保护条例合并来看，这些举措指向一个一致的方向：对主张什么、由谁持有、来自何处作出更明确的记录。
对外资医药与大健康企业的实务影响
传统知识尽职调查。 当项目涉及方药、技法或传统知识来源时，官方表述中的权利——表明身份、传承使用、知情同意、利益分享、完整保护、要求说明来源——提示来源与同意问题可能进入记录范围。企业宜留存取得方药或技法的途径与条件的书面材料。
合作协议。 与医院、科研院所及从业者的研究合作应有书面安排，就背景权利与前景权利、发表，以及共同形成成果的处理作出清晰约定。
专利与品牌布局。 规划在专利方面的方向与新修订《商标法》都倾向于奖励尽早且记录充分的申请策略。依赖独特名称与标识的资产组合，宜在新法施行后比照诚实信用与恶意申请相关条款作一次核对。
数字与人工智能相关工作。 规划中关于算法、人工智能生成物与数据知识产权的表述，与数字健康、人工智能辅助筛查及数据驱动研究相关，而这些领域中成果与数据集的归属往往并不确定。
关注官方记录。 由于条例草案尚未公布全文，具体登记路径、认定标准与惠益分享机制仍有待观察。待文本及配套办法发布后，宜重新审视既有规划。
相关考虑
医药与大健康领域的外商投资企业，本就需遵循药品、器械、医疗服务与广告等分行业规则。中医药传统知识保护条例增加的是一个知识保护层面，而非取代上述规则。把两个层面区分开来——可以制造与销售什么，以及可以何种条件使用何种知识——有助于避免把许可问题与市场准入问题混为一谈。
来源
- 国家知识产权局（《知识产权保护和运用”十五五”规划》专栏）：https://www.cnipa.gov.cn/col/col3692/index.html
- 酒泉市公安局（《知识产权保护和运用”十五五”规划》国发〔2026〕30号全文转载）：https://gaj.jiuquan.gov.cn/gaj/c106483/202609/856895252998428d9990e67d9af39108.shtml
- 国家知识产权局（官网，9月工作动态）：https://www.cnipa.gov.cn/?filter=0
- 大众网滨州（知识产权新规全国巡回宣贯，9月20日济南，9-23）：https://www.toutiao.com/article/7688564714451780098/
- 中国政府网：https://www.gov.cn/