- The 2026 action plan supports rules for drug segmented manufacturing to facilitate overseas marketing-authorisation holders in cross-border segmented production.
2026年行动方案支持出台药品分段生产细则，便利境外药品上市许可持有人开展跨境分段生产。- Pilot regions for biotechnology and wholly-foreign-owned hospitals will be further expanded.
生物技术、外商独资医院开放试点区域将进一步扩大。- Insurers are encouraged to cover more innovative drugs and devices, and quality innovative products are brought into the retail channel.
支持保险公司将更多创新药械纳入商业保险，推动优质创新药械进入零售渠道。- These are pharma-opening measures under the “stabilizing foreign investment” plan, complementing the general healthcare/pharma market-access brief.
上述为”固稳促优”方案下的医药开放举措，与通用的医药医疗准入综述互为补充。- Eligibility and pilot regions are announced by the drug regulator and pilot-region authorities.
资格与试点区域由药品监管及试点地区主管部门发布。- FIEs should assess segmented-manufacturing and hospital-pilot eligibility against their China strategy.
外资企业应结合自身中国战略，评估分段生产与人独资医院试点的适用性。
Pharma opening measures under the 2026 action plan | 医药产业开放新措施
Overview
As part of the Action Plan for Stabilizing and Improving Foreign Investment (利用外资固稳促优行动方案), China is advancing a set of pharma and healthcare opening measures (issued 16 June 2026, 商资发〔2026〕97号; effective from 1 July 2026). These refine and extend the market-access path for foreign pharma and medtech companies, sitting alongside the general healthcare/pharma market-access framework.
This article focuses on the pharma-specific openings and is intended as a complement to the broader “Healthcare & pharma market access” brief.
Informational guidance only; exact eligibility and pilot regions are set by the drug regulator (NMPA) and pilot authorities, so verify before acting.
Measures at a glance
Drug segmented manufacturing
- Study and issue rules for drug segmented manufacturing (药品分段生产实施细则).
- Facilitate overseas marketing-authorisation holders (MAH) in conducting cross-border segmented manufacturing of biologics and chemical drugs.
- Allows foreign MAHs to split the manufacturing process across sites/jurisdictions under defined rules, supporting flexible global supply.
Biotech and wholly-foreign-owned hospital pilots
- Expand pilot regions for biotechnology and wholly-foreign-owned hospitals (外商独资医院).
- Build an industry collaboration platform to help foreign-invested enterprises’ drugs enter the retail channel.
Insurance coverage and retail access
- Encourage insurers to include more innovative drugs and devices in commercial insurance coverage.
- Continuously encourage quality innovative drugs and devices to enter the China market.
How it relates to the broader access brief
- The general Healthcare & pharma market access article covers NMPA registration, licensing and the baseline path for foreign pharma/medtech entry.
- This brief covers the 2026 policy increments — segmented manufacturing, expanded pilots, and insurance/retail access — that lower specific frictions for foreign players.
- Read both: the access brief for the baseline; this brief for the newest openings.
What to do next
- Foreign MAHs: assess whether segmented manufacturing fits your supply chain and watch for the implementing rules and eligible sites.
- Medtech/pharma groups: track expanded biotech and wholly-foreign-owned hospital pilot regions for location and eligibility.
- Market-access teams: engage insurers and retail channels early to plan commercial-insurance and retail access for innovative products.
- Coordinate with the drug regulator (NMPA) and pilot-region authorities on eligibility and application windows.
- Combine this brief with the general market-access article when building your China pharma entry plan.
Sources
- 中华人民共和国中央人民政府（国务院）— 《利用外资固稳促优行动方案》全文：https://www.gov.cn/zhengce/zhengceku/202606/content_7072838.htm
- 国家药品监督管理局（官方门户）— https://www.nmpa.gov.cn
- 商务部 — 关于印发《利用外资固稳促优行动方案》的通知（商资发〔2026〕97号）：https://tradeinservices.mofcom.gov.cn/article/zcfb/zcfg/202606/183553.html
Related reading
- see also: Healthcare & pharma market access (NMPA) / 医疗医药准入（药监局）
- see also: Stabilizing Foreign Investment Action Plan: 15 measures at a glance / 利用外资固稳促优行动方案：15条举措总览
医药产业开放新措施
概述
作为《利用外资固稳促优行动方案》的一部分，中国推进一组医药与医疗开放举措（2026年6月16日印发，商资发〔2026〕97号；自2026年7月1日起落地）。这些举措细化并延伸了外资医药与医疗器械企业的准入路径，与通用的医药医疗准入框架并行。
本文聚焦医药专项开放，旨在作为更广泛”医疗医药准入”综述的补充。
本文仅为信息性指引；具体资格与试点区域由药品监管（NMPA）及试点主管部门规定，行动前请核实。
举措一览
药品分段生产
- 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（MAH）开展生物制品、化学药品的跨境分段生产。
- 在既定规则下，允许境外 MAH 将生产环节跨场地/辖区拆分，支撑灵活的全球供应。
生物技术与人独资医院试点
- 扩大生物技术与外商独资医院开放试点区域。
- 搭建行业协作平台，便利外资企业生产的药品进入零售渠道。
商保覆盖与零售可及
- 支持保险公司将更多创新药械纳入商业保险保障范围。
- 持续鼓励优质创新药械进入中国市场。
与通用准入综述的关系
- 通用的医疗医药准入文章涵盖 NMPA 注册、许可及外资医药/器械来华的基线路径。
- 本文涵盖2026年政策增量——分段生产、试点扩围、商保与零售可及——即降低外资特定摩擦的举措。
- 两篇对照阅读：准入综述看基线，本文看最新开放。
下一步建议
- 境外 MAH：评估分段生产是否契合供应链，关注实施规则与合格场地。
- 医疗器械/医药集团：跟踪生物技术与人独资医院试点扩围的区域与资格。
- 市场准入团队：尽早对接保险与零售渠道，规划创新产品的商保与零售可及。
- 就资格与申报窗口，与药品监管（NMPA）及试点地区主管部门协同。
- 制定中国医药入华方案时，将本文与通用准入综述结合使用。
来源
- 中华人民共和国中央人民政府（国务院）— 《利用外资固稳促优行动方案》全文：https://www.gov.cn/zhengce/zhengceku/202606/content_7072838.htm
- 国家药品监督管理局（官方门户）— https://www.nmpa.gov.cn
- 商务部 — 关于印发《利用外资固稳促优行动方案》的通知（商资发〔2026〕97号）：https://tradeinservices.mofcom.gov.cn/article/zcfb/zcfg/202606/183553.html
相关阅读
- see also: 医疗医药准入（药监局） / Healthcare & pharma market access (NMPA)
- see also: 利用外资固稳促优行动方案：15条举措总览 / Stabilizing Foreign Investment Action Plan: 15 measures at a glance