近期，部分医药行业动态引发了广泛关注，临床研究合规问题再次成为众多企业重点讨论的话题。多家企业就相关问题紧急联系我们进行了交流。随着中国临床研究和新药研发步入新的发展阶段，如何在合规风险中稳健前行，成为了大家共同关心的话题。
Several news have recently drawn widespread attention in China's life sciences industry, bringing compliance issues in clinical research under the spotlight. Numerous companies have reached out to us for urgent consultations on these matters. As China's clinical research and drug development enter a new stage of growth, how to effectively manage the compliance risk in the meantime of development has become a shared concern across the industry.
中国医药临床研究发展迅速，使得中国逐渐成为全球临床布局中不可忽视的一环。越来越多跨国药企选择在中国开展早期研究者发起的临床研究（IIT）与注册性临床试验。在此趋势背后，是监管体系十余年来持续改革所带来的深层变化——中国在审评审批机制、临床数据监管等方面持续优化，试验质量愈发获得国际监管机构的认可。（本所此前关于中国临床研究监管进展的解读文章请参见：汉坤 " 观点 | 热点追踪：药物临床试验机构日常监管风险提示；汉坤 " 观点 | 解读"722风暴"后时代药物临床试验机构检查新规）与此同时，中国在完善人类遗传资源监管的同时，不断合理简化临床研究的合规负担，切实支持研发。（本所关于人类遗传资源监管的解读文章请参见：汉坤 " 观点 | 重磅首发：《人类遗传资源管理条例实施细则》要点解读；汉坤 " 观点 | 新规速评：解读科技部最新人遗问答；汉坤 " 快评 | 《人类遗传资源管理条例》再次修订）
Clinical research in China has been developing rapidly, gradually positioning China as a key player in the global clinical landscape. An increasing number of multinational life sciences companies are choosing to carry out early-stage investigator-initiated trials (IITs) and registration clinical trials in China. This trend reflects over a decade of continuous regulatory reform, during which China has steadily refined its review and approval processes as well as clinical data oversight. As a result, the quality of trials conducted in China has received growing recognition from international regulatory authorities. (For our previous insights on the recent regulatory developments in China's clinical research sector, please refer to: 汉坤 " 观点 | 热点追踪：药物临床试验机构日常监管风险提示；汉坤 " 观点 | 解读"722风暴"后时代药物临床试验机构检查新规) At the same time, China has been continuously strengthening the regulation of human genetic resources (HGR), and also streamlining compliance requirements for clinical research to effectively support innovation and development. (For our insights on the HGR regulation in China, please refer to: Highlights on HGR Regulation Implementation Rules; Key Takeaways on the New HGR FAQs Issued by the MOST of China; 汉坤 " 快评 | 《人类遗传资源管理条例》再次修订)
中国临床研究生态亦同步成熟。临床研究机构（Site）、主要研究者（PI）、合同研究组织（CRO）、临床试验现场管理组织（SMO）等执行主体对临床研究项目的理解和执行能力显著提升，项目推进更为优质、高效。与此同时，随着中国药械企业"出海"步伐加快，对外许可（License-out）交易活跃，与跨国公司联合开展全球临床研究的案例不断涌现，进一步推动中国在全球药品注册与临床策略中的地位上移。（本所关于生物医药许可交易的解读文章请参见：2024年NewCo与药械License-in/out项目核心条款数据分析与对比；揭秘中国创新药企NewCo模式实战中的"六脉神剑"（中英双语）；药企出海新热点：管线分拆"SON"模式的实践解读；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's clinical research landscape has matured in parallel. Key stakeholders, including clinical sites (Sites), principal investigators (PIs), contract research organizations (CROs) and site management organizations (SMOs), have significantly improved their expertise in execution and operation in clinical research projects, resulting in higher quality and more efficient trials. Meanwhile, as Chinese drug and medical device companies rapidly expand their global footprint, license-out deals and collaborations with multinational life science companies are booming. This momentum is advancing China's position within the global landscape of drug registration and clinical development. (For our insights on licensing transactions in life science sector, please refer to: 2024 Data Analytics: China Life Sciences NewCo & Licensing Terms; Six Key Insights into China Biotech's NewCo Model; Insights into China Biotech's New Approach: Spin-off-NewCo Model; Anatomy of Licensing Deals from China Regulatory Perspective)
在此背景下，为助力行业更有效地识别和管控临床研究合规风险，推动新药研发高质量发展，我们起草了本文内容，供业界参考、讨论。
This article is intended to assist the industry in more effectively identifying and managing compliance risks in clinical research, thereby supporting the high-quality advancement of new drug development. We hope it will serve as a practical reference for industry's further discussion.
一、医药临床研究合规要点提示
Key Compliance Highlights in Life Sciences Clinical Research
（一）数据真实性与质量管理
Data Integrity and Quality Management
临床研究数据的真实性、完整性、规范性始终是临床研究的重中之重。一旦出现数据造假、病例入组标准不符、随访记录篡改等问题，将严重损害临床数据质量，影响医药产品的注册审批、商业化规划，更可能导致监管处罚和声誉受损。
The authenticity, completeness, and integrity of clinical research data remain fundamental to the success of any clinical research. Incidents such as data falsification, non-compliant subject enrollment, or manipulation of follow-up records can severely undermine data quality, jeopardize product registration and commercialization, and may trigger regulatory penalties by the authorities as well as reputational damage to the company.
中国监管不断完善临床研究质量监管法规。例如，2024年先后实施的《药物临床试验机构监督检查办法（试行）》《医疗器械临床试验机构监督检查办法》特别强调， 重点监管检查研究者同期承担临床试验项目较多、研究者管理能力或者研究人员数量相对不足等可能影响试验质量的临床试验机构。其他法规自上至下逐步衔接，从 《药品管理法》《医疗器械监督管理条例》到《药品注册核查要点与判断原则（试行）》《药物临床试验机构监督检查要点及判定原则（试行）》《医疗器械临床试验项目检查要点及判定原则》等实操性文件，中国临床研究质量管理要求严格、精细。
China has been continuously improving its regulatory framework for clinical research quality. For example, the Measures for Supervision and Inspection of Drug Clinical Trial Institutions (Trial) and the Measures for Supervision and Inspection of Medical Device Clinical Trial Institutions, both implemented in 2024, place emphasis on strengthening oversight of institutions where investigators are concurrently involved in a high volume of clinical trials, or where limited management capacity or insufficient research staffing may pose risks to data integrity and overall trial quality. China has developed a tiered and integrated regulatory framework for clinical research quality management—ranging from overarching laws such as the Drug Administration Law and the Regulation for the Supervision and Administration of Medical Devices, to practical guidelines including the Key Points and Criteria for Drug Registration Inspection (Trial), the Key Points and Criteria for Supervision and Inspection of Drug Clinical Trial Institutions (Trial) and the Key Points and Criteria for Supervision and Inspection of Medical Device Clinical Trial Projects. These developments reflect China's increasingly rigorous and granular approach to ensuring clinical trial quality.
企业应对照并落实所有相关且持续更新的法律法规要求，切实加强临床研究质量管理。
Companies are reminded to stay aligned with all applicable and evolving regulatory requirements, and to take active steps to strengthen oversight of clinical research quality.
（二）反腐败合规
Anti-Corruption Compliance
医药行业历来是中国反腐败监管的重点领域，临床研究亦处于监管高压线之中。特别在国家近几年持续深化开展医药领域腐败问题集中整治工作的背景下，医药行业更需要主动强化对临床研究活动中商业贿赂风险的合规管理。
Life sciences industry has long been a primary focus of China's anti-corruption regulatory enforcement, and clinical research remains subject to stringent regulatory scrutiny. Amid the intensified nationwide anti-corruption campaign targeting life sciences sector in recent years, there is an increased imperative for companies to proactively strengthen compliance management addressing commercial bribery risks associated with clinical research activities.
2025年1月国家市场监管总局发布的《医药企业防范商业贿赂风险合规指引》明确指出了企业在临床研究活动中应识别与防范的商业贿赂风险，包括禁止向临床试验机构及研究者输送不当利益以换取竞争优势、交易机会、不合理加快临床研究进程或者操作临床研究数据等。在实践中，监管部门会以此为基准，对临床研究活动是否构成商业贿赂行为进行审查。作为申办方的企业也应据此审查临床试验中是否存在可能被认定为商业贿赂的安排，例如：为了促使研究者放松入组标准、获得优先入组特权，或掩盖试验中发现的问题而给予研究者的患者招募奖励、数据核查奖励等。
The Compliance Guidelines for Healthcare Companies to Prevent Commercial Bribery Risks, issued by the State Administration for Market Regulation in January 2025, explicitly delineate the commercial bribery risks that companies should identify and mitigate in clinical research. Specifically, the guidelines prohibit offering improper benefits to clinical trial sites and investigators in exchange for competitive advantages, business opportunities, undue acceleration of clinical processes, or manipulation of clinical trial data. In practice, regulatory authorities will scrutinize clinical research activities based on these standards to determine whether commercial bribery has occurred. Sponsors should accordingly review their clinical trials for any arrangements that may be construed as commercial bribery, such as patient recruitment bonuses or data verification rewards provided to investigators, in order to relax enrollment criteria, grant preferential enrollment, or conceal issues discovered during the trial.
一旦企业被认定违反了《刑法》《反不正当竞争法》《药品管理法》等关于反商业贿赂的相关规定， 企业乃至相关负责人员都可能面临行政或刑事责任。特别是最新修订的《反不正当竞争法》首次在反法体系下规定企业的法定代表人、主要负责人和直接责任人员对实施贿赂负有个人责任，可没收违法所得并处一百万元以下的罚款。而《药品管理法》中则更早加入了个人的"资格罚"，规定药品上市许可持有人、药品生产企业、药品经营企业在药品研制、生产、经营中向国家工作人员行贿的，对法定代表人、主要负责人、直接负责的主管人员和其他责任人员终身禁止从事药品生产经营活动。
If a company is found to have violated anti-commercial bribery provisions under China's Criminal Law, Anti-Unfair Competition Law, or Drug Administration Law, both companies and their responsible personnel may face administrative penalties or criminal liabilities. Notably, the latest revision of the Anti-Unfair Competition Law introduces personal liability for the first time under the framework of anti-unfair competition, for a company's legal representatives, principal executives, and responsible individuals directly involved. These personnel may be subject to confiscation of illicit gains and fines up to RMB 1 million. The Drug Administration Law has introduced personal "disqualification penalties" earlier, providing that if drug marketing authorization holders, manufacturers, or distributors are found to have bribed public officials during drug development, manufacturing, or marketing activities, the legal representatives, principal executives, directly responsible supervisors, and other relevant personnel could face a lifetime ban from engaging in drug manufacturing or distribution activities.
因此，企业及其负责人应充分审查并确保临床研究活动，特别是费用发生等环节的真实性、合法性以及合理性。举例而言，《药物临床试验质量管理规范》明确要求， 申办方与研究者或试验机构签订的合同应明确各方应避免的及可能存在的利益冲突，且合同中的试验经费应合理且符合市场规律。若临床研究经费支付过高，可能引发监管关注，具体风险需结合项目实际情况进行综合评估和判断。
Accordingly, companies and their responsible personnel should conduct comprehensive reviews to ensure the authenticity, legality, and appropriateness of clinical research activities, with particular focus on financial expenditures, etc. For instance, the China Good Clinical Practice (GCP) explicitly requires contracts between sponsors, investigators, and sites to clearly address potential and actual conflicts of interest, and to ensure that trial funding is reasonable and consistent with market norms. Excessive payments in clinical research may trigger regulatory scrutiny, making it essential to evaluate risks carefully in the context of each specific project.
我们建议企业及相关负责人高度重视并从严防范反腐败风险，建立并执行有效的合规管理制度，主动解决处置发现的合规风险，切实守住临床研究的合规底线。
We recommend that companies and their responsible personnel take anti-corruption risks seriously by establishing and enforcing robust compliance programs, proactively addressing identified risks, and steadfastly upholding compliance standards in clinical research.
（三）其他要点提示
Other Key Issues
除上述重点外，临床研究还涉及多项合规要求，包括但不限于 人类遗传资源管理、伦理审查、数据合规与个人信息保护、受试者损伤赔偿责任。鉴于篇幅所限，本文暂不详述相关内容，欢迎有相关需求的读者随时与我们联系，进行深入交流。（本所此前关于人类遗传资源与伦理审查监管的解读文章请参见：十大雷区：中国人类遗传资源项目申报避坑指南；汉坤 " 观点 | 伦理审查新规重点快评；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；汉坤 " 观点 | 解读2024年版《赫尔辛基宣言》最新亮点 — 全球医学研究伦理准则系统性更新）
Apart from the key considerations outlined above, clinical research is also subject to a range of other compliance requirements, including but not limited to HGR management, ethics review, data compliance and personal information protection, as well as subject injury compensation. Given the scope of this article, we will not elaborate on these topics herein. If you would like to explore any of these topics in more detail, please feel free to contact us. (For our previous insights on the HGR regulation and ethical review, please refer to: Top 10 Traps to Avoid: Navigating China's HGR Applications; 汉坤 " 观点 | 伦理审查新规重点快评; China Released New Ethics Rules Requiring Company's Internal EC; 汉坤 " 观点 | 解读2024年版《赫尔辛基宣言》最新亮点 — 全球医学研究伦理准则系统性更新)
二、医药临床研究风险应对建议
Practical Strategies for Managing Clinical Research Risks
（一）风险排查
Risk Identification and Assessment
建议对公司及集团范围内既往、在研及未来规划的临床研究项目进行系统排查，包括自研项目、合作项目，重点识别可能影响合规底线或商业化进程的关键风险。此外，对于 拟开展投融资、并购、许可交易或IPO等商业安排的企业，临床研究相关的合规问题也往往是尽调中的敏感项，可能成为估值与交易能否实现的关键变量之一。
Companies and their corporate groups are encouraged to undertake a systematic review of all clinical research projects, including past, ongoing, and planned ones, whether self-initiated or collaborative, to identify key risks that may compromise regulatory compliance or undermine commercialization processes. Moreover, for enterprises considering financing, mergers and acquisitions, licensing arrangements, or IPOs, compliance issues related to clinical research often constitute key areas of due diligence and can be critical factors influencing valuation and the transaction outcomes.
实践中，伦理审查的合规情况、经费设置的合理性、试验机构与研究者的项目情况、外部合作方的合规背景、合同文件的安排，都是值得重点关注的环节。每一类问题背后往往牵涉复杂判断与项目特殊性，需要具体结合实际情况综合研判项目风险。我们建议企业对临床研究合规予以特别重视，由内部或外部法律顾问协作进行风险排查。
In practice, key aspects requiring careful attention include the compliance status of ethics review, the reasonableness of financial terms, the roles and performance of clinical sites and investigators, the compliance background of collaborators, and the structure and terms of agreements. Each of these areas requires careful and case-by-case risk analysis due to the complexity and project-specific characteristics. We recommend that companies place special emphasis on clinical research compliance and conduct thorough risk reviews in collaboration with internal or external legal counsel.
（二）整改与应对
Remedies and Responses
对于风险点集中或潜在合规问题突出的项目和协议，建议开展专项合规审查与风险评估，结合实际情况制定切实可行的整改措施并加以执行。整改方式可包括（但不限于）： 制定专项 CAPA（纠正与预防措施）、补充合规条款、修订既有协议、在交易文件中作出针对性安排，或重新评估相关商业计划。对于已引起监管关注或存在重大合规缺陷的情形， 亦应同步制定监管应对方案，妥善回应监管反馈、降低潜在影响。必要时，亦可 评估是否终止相关合作，以维护企业整体利益。
For projects and agreements with key risk areas or significant potential compliance issues, targeted compliance reviews and risk assessments are recommended. Based on the specific circumstance, practical corrective measures should be implemented, including, but are not limited to, implementing dedicated CAPA (Corrective and Preventive Actions), supplementing compliance clauses, revising existing agreements, adding tailored provisions in transaction documents, or reassessing relevant business plans. In cases that have drawn regulatory attention or involve serious compliance deficiencies, it is essential to develop regulatory response strategies to address feedback and mitigate potential impact. Where necessary, companies should also consider whether terminating the relevant cooperation is warranted to protect overall corporate interests.
（三）合规建设与监管关注
Compliance Development and Regulatory Monitoring
建议在内部或外部法律顾问的协助下， 建立、完善临床研究合规管理体系，明确职责分工，规范操作流程。 通过内部或外部法律专家定期开展合规培训，切实提升相关人员的合规意识与执行规范。同时， 密切关注药监部门及相关监管机构发布的最新法规政策与执法动态，及时调整策略，更新管理制度。
We recommend companies establish and continuously improve their clinical research compliance management systems with support from internal or external legal counsel by clearly defining responsibilities and standardizing procedures. Regular training by internal or external legal experts is also essential to raise awareness and ensure effective implementation. Meanwhile, companies should closely monitor the latest regulations, policies, and enforcement updates from drug regulatory authorities, and accordingly adjust strategies and update management systems.
我们亦将密切关注监管动向，结合实践经验，为企业提供及时、专业的政策解读与应对支持。
We will also keep a close watch on regulatory trends and, drawing on practical experience, provide companies with timely and professional policy insights and support.
结语
Conclusion
当前，中国医药行业正处于百舸争流、蓬勃发展的新时代，临床研究亦面临前所未有的机遇与挑战。随着监管体系日益完善和合规指引不断细化，中国临床试验的质量管理水平持续提升，为创新医药产品研发提供了坚实保障，也为行业的健康发展奠定了基础。我们相信，未来中国医药产品研发的道路将更加稳健，迈向国际舞台的步伐也将更加坚定。
China's life sciences sector is entering a dynamic and vibrant new phase, with clinical research facing unprecedented opportunities and challenges. As regulatory framework becomes more comprehensive and compliance guidelines become increasingly detailed, the quality management of clinical trials in China continues to advance, providing a solid foundation for the development of innovative medical products and supporting the sustainable growth of the industry. We believe China's life sciences sector will grow increasingly robust and make stronger strides onto the global stage.
我们也将持续陪伴，助力中国医药企业完善合规管理，深耕本土市场，拓展全球视野。同时，我们也致力于支持外国企业顺利进入中国市场，帮助其识别和防范合规风险，推动多方合作，实现共赢发展。
We will continue to stand alongside Chinese life sciences companies, helping them improve compliance management and strengthen their domestic presence, and expand globally. At the same time, we remain committed to supporting foreign enterprises in navigating the Chinese market, identifying and managing compliance risks, fostering collaboration, and achieving mutually beneficial outcomes.
Originally published 2025年07月08日 12:53
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