Translated by ChatGPT, edited by Sinocism.com.

Source: The Paper | Author: Zhao Lixin (赵利新), The Paper reporter | October 17, 2026

On October 16, the Ministry of Commerce and the Ministry of Science and Technology issued Announcement No. 48 of 2026, publicly soliciting comments on revisions to the Catalogue of Technologies Prohibited or Restricted from Export from China (the “Catalogue”) and imposing temporary administrative measures requiring pre-export registration for relevant technologies.

10月16日，商务部、科技部发布2026年第48号公告，就修订《中国禁止出口限制出口技术目录》（以下简称《目录》）公开征求意见，并对相关技术实施出口前登记的临时管理措施。

A Ministry of Commerce spokesperson said that the current Catalogue already contains some biopharmaceutical technologies. The proposal would add five technologies involving pathogenic microorganisms, cell and gene therapy, and small-nucleic-acid drugs, principally for the following reasons:

商务部新闻发言人称，现行《目录》中已有部分生物医药技术，此次拟增列病原微生物、细胞和基因治疗、小核酸药相关5项技术，主要有以下考虑：

First, to protect human life, health and safety. Pathogenic-microorganism technologies and related technologies directly concern human health and national biosecurity. Including them in the Catalogue as technologies prohibited from export is an institutional arrangement for safeguarding national security and constructing a biosecurity barrier, as well as an objective requirement for protecting the health of all humanity.

一是维护人类生命健康安全。病原微生物技术等直接关系人类健康和国家生物安全，将其纳入《目录》实施禁止出口，是维护国家安全、构筑生物安全屏障的制度安排，也是保护全人类健康的客观需要。

Second, to support orderly international cooperation involving China’s biopharmaceutical technologies in accordance with laws and regulations. The controls on biopharmaceutical technologies exclude important forms of international cooperation or apply facilitation measures to them. For example, exports involving overseas licensing of relevant proprietary technology-process platforms or the use of relevant technologies and processes to provide outsourced R&D and production services are not included within the scope of administration. Exports by overseas licensing of relevant proprietary target-discovery and validation technologies are subject to facilitation measures such as automatic licensing.

二是支持我国生物医药技术依法依规有序开展国际合作。此次列管生物医药技术，对国际合作的重要情形作出排除或适用便利措施。例如，对具有自主知识产权的相关技术工艺平台，对外授权许可、利用相关技术工艺提供外包研发和生产服务等出口情形，不纳入管理范围；对于具有自主知识产权的相关靶点发现和验证技术，对外授权许可方式出口的，适用自动许可等便利措施。

Third, to put into practice the concept of a global community of health for all. The policy explicitly provides that exports of technologies restricted from export that are needed for public-health emergencies, humanitarian assistance or joint R&D using overseas resources will be subject to facilitation measures such as automatic licensing. China will continue to share the achievements of technological development with countries around the world and make an active contribution to improving human health and well-being.

三是践行人类卫生健康共同体理念。此次政策明确规定，对于限制出口技术，因公共卫生突发事件、人道主义救援、利用境外资源开展联合研发等需要的出口，适用自动许可等便利措施。中国将继续与世界各国共享技术发展成果，为增进人类健康福祉作出积极贡献。

Hu Haitao, a researcher and doctoral supervisor at the Institute of Microbiology of the Chinese Academy of Sciences, said it is particularly important to note that the Catalogue draws very clear control boundaries for cutting-edge platform technologies such as cell and gene therapies and small-nucleic-acid drugs. It by no means rejects normal industrial exports or international cooperation. The core of the controls is overseas transfers of ownership of foundational platform technologies covered by independent intellectual-property rights. Their purpose is to prevent “root-uprooting” transfers and keep ownership of independently developed foundational technologies with independent intellectual-property rights inside China.

中国科学院微生物研究所研究员、博士生导师胡海涛表示，值得特别注意的是，本次目录对细胞与基因治疗、小核酸药物等前沿平台技术的管控边界十分清晰，绝非否定正常的产业出口和国际合作。管控的核心是自主知识产权的底层平台技术所有权对外转让，旨在防范“拔根式”转让，而将自主研发、具有自主知识产权的底层技术所有权保留在国内。

“The policy does not prohibit overseas licensing, cooperative development or licensing transactions involving specific innovative-drug products and projects; instead, it will encourage and support them through a number of facilitation measures. The aim of these precise controls is to guide companies to turn innovation achievements into long-term international competitiveness, propel China’s biopharmaceutical industry toward the high end of the value chain, and at the same time protect their own intellectual property,” he said.

“对于具体创新药物产品和项目的海外授权、合作开发与许可交易，该政策并未禁止，并将通过一些便利化措施予以鼓励和支持。这种精准管控，是为了引导企业将创新成果转化为长远国际竞争力，推动中国生物医药向价值链高端跃升，同时保护自己的知识产权。”他说。

Hu believes that although China still has a certain gap with the world’s most developed countries in foundational biopharmaceutical technologies, it has made significant progress in recent years in such subfields as construction of new platforms and discovery of new targets, and its international share of basic and translational research has continued to rise. These new technologies also face a degree of outflow risk. The policy orientation of the new controls is also very clear: guide companies in retaining ownership of technologies while actively using domestic and foreign capital to promote the long-term, stable and healthy development of China’s innovative-drug R&D. This protects innovation achievements and also reflects consideration for the industry’s long-term development as a whole.

胡海涛认为，在生物医药底层技术层面，虽然我们与全球最发达国家仍然存在一定差距，但近年来我国在新平台构建、新靶点发现等细分领域也取得了显著进步，基础和转化研究领域的国际比重越来越高。这些新技术也面临着一定的外流风险。此次列管的政策导向也十分明确：引导企业把握住技术所有权，同时积极利用国内外资金，推动中国创新药研发的长期、稳定和健康的发展。这是对创新成果的保护，也是对整个产业长远发展的考量。