- On 15 May 2026 the revised Implementation Regulations of the Drug Administration Law took effect, with Article 32 expressly allowing segmented (split-site) production of qualifying innovative drugs under a unified quality-assurance system.
2026年5月15日，新修订的《药品管理法实施条例》施行，其中第三十二条明确允许符合条件的创新药在统一质量保证体系下分段委托生产。
- The State Drug Administration has separately worked on biological-product segmented production; the 2026 Action Plan to Stabilise and Optimise Foreign Investment now calls for detailed rules for cross-border segmented production of both biologicals and chemical drugs.
国家药监局已就生物制品分段生产单独发文推进；2026年《利用外资固稳促优行动方案》进一步提出研究出台药品分段生产实施细则，便利境外药品上市许可持有人开展生物制品、化学药品跨境分段生产。
- Segmented production applies to innovative drugs with special production-process or facility requirements, clinically urgent drugs, and drugs needed for public-health emergencies, as designated by the State Council.
分段生产适用于生产工艺、设施设备有特殊要求的创新药，临床急需的药品，以及突发公共卫生事件急需或储备需要的药品等国务院规定情形。
- The marketing authorisation holder (MAH) remains the single, final quality-responsible party and must build a unified quality-assurance system spanning all production sites.
药品上市许可持有人（MAH）仍是唯一、最终的质量责任主体，必须建立覆盖药品生产全过程和全部生产场地的统一质量保证体系。
- For foreign MAHs, the combination of segmented production and the FIE action plan opens a path to structure cross-border biologics and chemical manufacturing while keeping Chinese regulatory responsibility centralised.
对外资MAH而言，分段生产与稳外资行动方案的组合，为跨境生物制品与化学药品生产布局开辟了路径，同时保持中国监管责任集中化。
- Commercial insurers are also being encouraged to cover more innovative drugs and devices, and foreign-made drugs gain smoother entry into retail channels.
政策同时鼓励保险公司将更多创新药械纳入商业保险保障范围，并便利外资企业生产的药品进入药品零售渠道。
Segmented Pharmaceutical Production in China: A New Manufacturing Option for Foreign MAHs | 中国药品分段生产：外资上市许可持有人的制造新选项
Why this matters now
Pharmaceutical manufacturing has traditionally meant one site, one product, one end-to-end process. China’s 2026 regulatory wave is deliberately unpicking that assumption. On 15 May 2026, the revised Implementation Regulations of the Drug Administration Law took effect, and Article 32 explicitly permits the segmented production of qualifying innovative drugs — where manufacturing steps run at different sites and potentially through different companies — as long as the marketing authorisation holder maintains a unified quality-assurance system. The move is paired with an explicit signal to foreign investors: the June 2026 Action Plan to Stabilise and Optimise Foreign Investment (issued by MOFCOM, NDRC and MOF) commits to detailed rules for cross-border segmented production of biological products and chemical drugs, building on the earlier biological-product segmented-production pilot. For a global pharma company with an approved innovative molecule, this changes how production for the Chinese market can be structured.
What segmented production covers
Article 32 of the revised Implementation Regulations permits segmented production for three categories: innovative drugs whose production process, equipment or facilities have special requirements; clinically urgent drugs requested by relevant State Council departments; and drugs needed for emergency response or stockpiling. The MAH may commission qualified production enterprises to handle separate production steps. Critically, the law does not decentralise responsibility: the MAH must establish a unified quality-assurance system covering the entire production process and all production sites, and remains the single final responsible party for product quality. The State Drug Administration’s inspection guidance for biological-product segmented production further requires the MAH to align quality-management systems across segment producers, apply quality-risk management to contamination and cross-contamination risks, and ensure the quality authorisation holder can base final release decisions on a full review of data from all segments.
The foreign-investment angle
The FIE Action Plan published in June 2026 explicitly says the authorities will move quickly to issue implementation rules for segmented production, to facilitate overseas drug marketing authorisation holders in carrying out cross-border segmented production of biologicals and chemical drugs. This is the first time the policy explicitly opens the door to cross-border arrangements — a Chinese plant handling one production step, an overseas site another. For foreign MAHs, the practical attraction is manufacturing flexibility: an API or biologic intermediate can be produced at the site with the best economics and IP-protection profile, with final formulation and packaging in China, while quality oversight remains anchored in one unified system. The same plan adds supporting measures: expanding the pilot scope for biotechnology and wholly foreign-owned hospitals, encouraging commercial insurers to cover more innovative drugs and devices, and easing foreign-made drugs into retail pharmacy channels.
Practical steps for foreign MAHs
- Map your portfolio. Identify molecules that qualify for segmented production — innovative drugs with special process or facility needs, clinically urgent products, or emergency/stockpile candidates.
- Decide the China anchor. Choose which production step will be performed in China and by which qualified manufacturer, and where the MAH quality-authorisation function will sit.
- Design the unified quality system. Draft the single quality-assurance framework covering all sites and segments, including technology transfer, change control, deviation handling and CAPA procedures.
- Engage the SDA early. Because implementation rules for chemical cross-border segmented production are still being drafted, use pre-submission consultation channels to align on expectations before committing investment.
- Review supply-chain economics. Model the tax, customs and logistics treatment of intermediates moving across borders, including bonded and duty-free options where available.
- Coordinate with insurance and retail access. Plan for how the product will reach patients — commercial insurance coverage and retail channel entry both affect market-access planning.
Risks and compliance notes
Segmented production is a permission, not a relaxation. The MAH’s single-responsibility rule means a failure at any segment is ultimately the MAH’s failure; contract manufacturers’ systems must be auditable and aligned. Foreign MAHs should also track the still-evolving implementation rules for chemical cross-border segmented production — until they issue, cross-border arrangements for small-molecule drugs should be structured conservatively. IP protection of process know-how across borders, GMP consistency between sites, and batch-release responsibilities all need contractual precision. Finally, the SDA’s on-site inspection and post-market supervision powers are unchanged, so documentation and traceability must satisfy the same standards as single-site production.
中国药品分段生产：外资上市许可持有人的制造新选项
为什么当下重要
药品生产传统上意味着”一个场地、一个产品、一条端到端流程”。中国2026年的监管浪潮正有意拆解这一假设。2026年5月15日，新修订的《药品管理法实施条例》施行，第三十二条明确允许符合条件的创新药分段生产——即制造环节在不同场地、甚至经由不同公司运行——只要上市许可持有人维护统一质量保证体系。该举措与对外资投资者的明确信号相配合：2026年6月商务部、国家发展改革委、财政部发布的《利用外资固稳促优行动方案》承诺研究出台生物制品与化学药品跨境分段生产实施细则，在早期生物制品分段生产试点基础上推进。对拥有获批创新分子的全球制药企业而言，这改变了中国市场的生产布局方式。
分段生产覆盖哪些情形
修订后《实施条例》第三十二条允许三类药品分段生产：生产工艺、设施设备有特殊要求的创新药；国务院有关部门提出的临床急需药品；以及应对突发公共卫生事件急需或储备需要的药品。MAH可以委托符合条件的生产企业承担不同生产步骤。关键在于，法律并未分散责任：MAH必须建立覆盖药品生产全过程和全部生产场地的统一质量保证体系，并作为产品质量唯一且最终的责任主体。国家药监局生物制品分段生产现场检查指南进一步要求MAH使各分段生产企业的质量管理体系有效衔接与统一，运用质量风险管理方法识别控制污染、交叉污染及差错风险，并确保质量受权人能基于对各分段数据的全面审核作出最终放行决定。
外资维度
2026年6月发布的稳外资行动方案明确提出，抓紧研究出台药品分段生产实施细则，便利境外药品上市许可持有人开展生物制品、化学药品跨境分段生产。这是政策首次明确为跨境安排敞开大门——中国工厂承担一个生产步骤，海外场地承担另一个。对外资MAH而言，实际吸引力在于制造灵活性：原料药或生物制品中间体可在经济性与知识产权保护最优的场地生产，最终制剂与包装放在中国，而质量监督仍锚定于一个统一体系。同一方案还附带了配套措施：扩大生物技术、外商独资医院开放试点区域范围，支持保险公司将更多创新药械纳入商业保险，并便利外资企业生产的药品进入零售药店渠道。
外资MAH的操作步骤
- 梳理产品组合。 识别符合分段生产条件的分子——生产工艺或设施有特殊要求的创新药、临床急需产品或应急／储备候选品。
- 确定中国锚点。 选择哪个生产步骤在中国、由哪家合格生产商执行，以及MAH质量受权职能设在何处。
- 设计统一质量体系。 起草覆盖全部场地与分段的单一质量保证框架，包括技术转移、变更控制、偏差处理与CAPA程序。
- 尽早与国家药监局沟通。 由于化学药品跨境分段生产实施细则仍在起草中，在投入投资前应利用预沟通渠道对齐预期。
- 审查供应链经济性。 建模中间体跨境流动的税收、海关与物流处理，在可行时考虑保税与免税选项。
- 协同保险与零售准入。 规划产品如何触达患者——商业保险覆盖与零售渠道进入都影响市场准入规划。
风险与合规提示
分段生产是许可，不是放松。MAH单一责任规则意味着任何分段的失败最终都是MAH的失败；合同生产商的体系必须可审计、可对齐。外资MAH还应跟踪仍在制定的化学药品跨境分段生产实施细则——在细则出台前，小分子药物跨境安排应保守设计。跨境工艺know-how的知识产权保护、场地间GMP一致性、批次放行责任都需要合同上的精确性。最后，药监局现场检查与上市后监管权限不变，因此文档与可追溯性必须满足与单一场地生产相同的标准。
Sources
- 商务部 国家发展改革委 财政部《利用外资固稳促优行动方案》（商资发〔2026〕97号）——第三条”支持外资参与医药等产业高质量发展”（研究出台药品分段生产实施细则、便利境外MAH跨境分段生产）：<https://sxdofcom.shaanxi.gov.cn/fdi/yhzc/40265.jhtml>
- 商务部副部长凌激出席国新办发布会介绍利用外资固稳促优有关政策措施（王亚回应医药开放措施，生物制品分段生产试点、化学药品跨境分段生产细则）：<https://swj.wulanchabu.gov.cn/zxft/1994919.html>
- 中国医药创新促进会《药品管理法实施条例大家谈 在鼓励创新与严守底线间找到平衡》（第三十二条分段生产、MAH统一质量保证体系解读）：<https://www.phirda.com/artilce_43447.html>
- 山西省民营经济发展局官网《外资企业可重点关注哪些扩大准入领域？》（2026-08-10，摘自商资发〔2026〕97号：药品分段生产、生物技术和外商独资医院领域扩大开放）：<https://myj.shanxi.gov.cn/ztzl/bwbd/lywzgw/202608/t20260810_10196322.shtml>