制药企业与第三方检测机构开展药物临床试验样本检测合作要点与风险防控探讨

Key points and risk prevention and control in cooperation on sample testing of drug clinical trials between pharmaceutical companies and third-party testing institutions

摘要

目的: 为制药企业与第三方检测机构在药物临床试验样本检测合作中的合规化管理提供参考。方法: 结合药物临床试验样本检测合作的实际情况,从合作要点和风险防控角度,剖析双方合作中的核心要点与潜在风险,并提出针对性防控策略。结果: 总体来看,合作中的违规行为可能使双方面临民事责任、行政责任甚至刑事责任。从合作实践来看,制药企业与第三方检测机构普遍存在服务内容界定模糊、权利义务划分不清、质量控制不足等问题。从行业环境来看,药物临床试验监管趋严,对样本检测的规范性和数据真实性要求不断提高。结论: 制药企业与第三方检测机构在样本检测合作中应明确合作要点,包括细化服务范围、规范费用结算、界定技术成果归属、落实保密义务、建立沟通机制及标准化委托协议,应强化风险防控意识,完善合规管理体系。同时针对审批缺失、转包分包、质量失控、费用争议、知识产权侵权等风险构建针对性防控措施,以保障临床试验数据质量与受试者安全,维护双方合法权益,推动合作稳定有序开展。

Abstract

Objective: To provide a reference for the compliance management of sample testing cooperation between pharmaceutical companies and third-party testing institutions in drug clinical trials. Methods: Based on the actual practice of sample testing cooperation in drug clinical trials, this paper analyzes the core points and potential risks in the cooperation from the perspectives of cooperation key points and risk prevention and control, and proposes targeted prevention and control strategies. Results: Overall, non-compliant behaviors in the cooperation may expose both parties to civil liability, administrative liability, or even criminal liability. From the perspective of cooperation practice, pharmaceutical companies and third-party testing institutions generally face problems such as vague definitions of service content, unclear division of rights and obligations, and insufficient quality control. From the perspective of the industry environment, drug clinical trials regulation is becoming increasingly stringent, with continuously rising requirements for the standardization of sample testing and data authenticity. Conclusion: In sample testing cooperation between pharmaceutical companies and third-party testing institutions, both parties should clarify the key points of cooperation, including refining the scope of services, standardizing expense settlement, defining the ownership of technological achievements, fulfilling confidentiality obligations, establishing a communication mechanism and adopting standardized entrustment agreements. They should also strengthen their awareness of risk prevention and control and improve their compliance management systems. At the same time, targeted prevention and control measures should be constructed against risks such as approval deficiencies, subcontracting, quality control failures, expense disputes, and intellectual property infringement, so as to ensure the quality of clinical trial data and the safety of subjects, safeguard the legitimate rights and interests of both parties, and promote the stable and orderly development of cooperation.    

关键词

药物临床试验 / 样本检测 / 合作要点 / 风险防控 / 合作协议 / 合规管理

Key words

drug clinical trial / sample testing / key points of cooperation / risk prevention and control / cooperation agreement / compliance management

[1] 韩佳, 曾文晔, 史彤, 等. 2023年新药研发发展现状与未来趋势[J]. 生命科学, 2024, 36(1): 94-101.
[2] 国家药品监督管理局药品审评中心. 中国新药注册临床试验进展年度报告(2023年)(摘登)[N]. 中国医药报, 2024-05-30(002).
[3] 权菊香, 赵敏, 单爱莲. 合同研究组织在临床试验中的作用与存在的问题[J]. 中国临床药理学杂志, 2010, 26(7): 549-551.
[4] 中国药理学会药物临床试验专委会, 中国生物分析论坛. 药物临床试验生物样本编码和标签操作指南[J]. 中国临床药理学与治疗学, 2021, 26(9): 975-977.
[5] 国家市场监督管理总局. 检验检测机构监督管理办法(2021年4月8日国家市场监督管理总局令第39号公布根据2025年3月18日国家市场监督管理总局令第101号修订)[EB/OL].(2025-04-03)[2025-07-19].https://www.samr.gov.cn/zw/zfxxgk/fdzdgknr/fgs/art/2025/art_bff8f35d8f114acca7643bddd77e9505.html.
[6] GUMMERUS A, AIRAKSINEN M. Values and disadvantages of outsourcing the regulatory affairs tasks in the pharmaceutical industry in EU countries[J]. Pharmaceut Reg Affairs, 2016, 5(1): 1-5.
[7] 李轩. 制药企业对CRO的选择及管理研究[D]. 沈阳: 沈阳药科大学, 2008.
[8] 郑妤婕, 余选绒, 刘博琳, 等. 药品监管法治体系建设中风险管理理念的演进与深化[J].中国现代应用药学, 2025, 42(10): 1630-1634.
[9] 国家药品监督管理局, 国家卫生健康委员会. 国家药监局国家卫生健康委关于发布药物临床试验质量管理规范的公告[J]. 中华人民共和国国务院公报, 2020(19): 65-86.
[10] 张凯平, 梁燕玲, 陈炜璇, 等. 药物临床试验外包风险及管理策略分析[J]. 药物评价研究, 2022, 45(1): 171-176.
[11] 赵同香, 蒋向明, 王海英, 等. 探讨药物临床试验生物样本流通环节常见问题及风险前置化管理措施[J]. 中国食品药品监管, 2021(3): 44-51.
[12] 谢江川, 谢林利, 马攀, 等. 药物临床试验中生物样本管理常见问题及措施建议[J]. 中国药房, 2024, 35(5): 524-528.
[13] 武汉市江汉区人民法院. 杜显清诈骗罪刑事判决书[EB/OL].(2023-12-28)[2025-07-18].https://wenshu.court.gov.cn/website/wenshu/181107ANFZ0BXSK4/index.html?docId=zD9uQTa5PrBry+Vh6rFA+2SEv4IZFC3rNYiYDqmzb4nRhdSns2+g3ZO3qNaLMqsJ6tMgGGNYqRBhvNmwL6gFRQXPW2XZq4AKKNEPPyMQZRewU39KpXa77b6+B1ONj2Ya7P44twaNnrRaKsnak3cP6acg5KujAFYm.
[14] 蔡雨阳, 李际, 任军, 等. 基于“先进合同研究组织”的生物医药产业创新模式探讨[J].中国药房, 2009, 20(31): 2401-2404.
[15] 新浪财经. “AI制药第一股”晶泰科技遭合同纠纷[EB/OL].(2025-03-13)[2025-07-18].http://m.toutiao.com/group/7481273362875040294/.
[16] 陈兴平, 吴红丽, 李梦景, 等. 医药技术开发合同的知识产权成果权属风险与防控[J]. 中国科技纵横, 2021(24): 148-150.
[17] 孙海龙, 姚建军. 委托开发的专利权归属[EB/OL].(2008-07-09)[2025-07-19].https://www.ciplawyer.cn/articles/122945.html.
[18] 曹卫星. 挑战制药领域办案难题[N]. 检察日报, 2024-11-26(002).
[19] 中华人民共和国最高人民法院. 北京世贸东某医药科技有限公司与丰华生物有限公司、张慧君侵害技术秘密纠纷二审判决书[EB/OL].(2024-02-23)[2025-07-18].https://wenshu.court.gov.cn/website/wenshu/181107ANFZ0BXSK4/index.html?docId=EpzSMH6XnFxiPGP/qHBqjmB1uVv1MYf49TWSrtoD+yDE/5rDxNWWVZO3qNaLMqsJ6tMgGGNYqRBhvNmwL6gFRQXPW2XZq4AKKNEPPyMQZRewU39KpXa77b6+B1 ONj2Ya7P44twaNnrRaKsnak3cP6dhIvtsPsjUh.
[20] HENNIG M, HUNDT F, BUSTA S, et al. Current practice and perspectives in CRO oversight based on a survey performed among members of the German Association of Research-Based Pharmaceutical Companies (vfa)[J]. Ger Med Sci, 2017, 15: Doc02.
[21] 葛永彬, 董剑平, 胡乾康. 新修订《药品管理法》诠释“最严厉的处罚”——通过经典案例探讨药企合规风险防范[J]. 中国食品药品监管, 2021(4): 64-69.
[22] 高彤. CRO企业股权激励的方案设计及效果研究——以泰格医药为例[D]. 成都: 西南财经大学, 2023.
[23] 广东省药学会. 药物临床试验机构经费管理·广东共识(2019)[J]. 今日药学, 2020, 30(3): 145-149.
[24] 李贤明. TS企业仿制药CRO委托项目风险管理研究[D]. 北京: 北京化工大学, 2020.
[25] 李睿, 唐旭东, 陆芳, 等. 中药临床研究ARO-CRO项目管理运行模式探讨[J]. 中国新药杂志, 2016, 25(7): 775-778, 786.