China’s MOFCOM/MOST Notice 48: What the New AI and Biopharma Export Controls Mean for Healthcare

AI Industry Watch

On October 16, 2026, China's Ministry of Commerce (MOFCOM) and Ministry of Science and Technology (MOST) jointly issued Announcement No. 48, proposing to add 40 technologies to the Catalogue of Technologies Prohibited or Restricted from Export and implementing a temporary pre-export registration requirement on those same technologies effective immediately.

The 40 technologies span three sectors: 23 in artificial intelligence, 5 in biomedicine, and 12 in photovoltaics. For healthcare organizations, the biomedicine entries are the most direct concern. The AI entries matter in a second-order way — through vendor relationships, research partnerships, and the governance questions they raise for health systems that have deployed or are evaluating Chinese-origin AI models or agents.

This post covers what the announcement says, what it does not say, and what healthcare security and compliance teams should be watching.

What Notice 48 Is and What It Does Right Now

The Catalogue of Technologies Prohibited or Restricted from Export is a longstanding instrument of Chinese trade policy, revised periodically since 2001. The catalogue defines which technologies Chinese entities need government approval to transfer to foreign parties. Technologies in the prohibited category cannot be exported under any license. Technologies in the restricted category require a license before export, though certain facilitation mechanisms — including a newly proposed "automatic licensing" pathway — can streamline that process.

Notice 48 does two things simultaneously. First, it opens a public comment period on proposed additions to the catalogue, running from October 16 to November 15, 2026. The additions are proposals — not yet final. Second, it imposes a temporary pre-export registration requirement on those same technologies effective the day of the announcement. Registration is not approval, but it is a compliance obligation that applies now, before the catalogue changes are finalized. Exports already in progress but not yet completed are covered.

The registration platform is MOFCOM's technology trade management system at ecomp.mofcom.gov.cn. The registration triggers are: transferring technology ownership abroad (including IP transfer), licensing domestic technology for overseas use, a change in ownership or actual control of the domestic technology to a foreign entity, and any other cases MOFCOM specifies by notice.

MOFCOM has stated the notice is "not targeted at any specific country, region or entity."

The Technology Scope: What's Proposed and What Isn't in This Post

Notice 48 links to two annexes: Annex 1, the draft technology scope with technical definitions and control parameters, and Annex 2, the registration form. Both are in WPS Office format (.wps) and were not available for review. The specific technical definitions and thresholds in Annex 1 should be accessed directly through the MOFCOM source link or through legal counsel. The specific technical definitions, quantitative thresholds mentioned in Annex 1, and the exact registration fields in Annex 2 are available only from those files directly. Readers who need to assess compliance against specific technical parameters should access Annex 1 through the MOFCOM source link or through legal counsel with access to the documents.

What is confirmed from the notice text and the MOFCOM spokesperson's public statements, which can be verified:

AI: 23 Technologies

The proposed AI scope covers large model technology, AI agent technology, AI computing cluster technology, technologies for high-performance detection and information countermeasures (including cyber offense and defense capabilities), and information processing technology (including speech recognition, voiceprint recognition, and Chinese-language translation).

The proposed catalogue distinguishes between prohibited and restricted categories within AI. The prohibited category — no license available — includes AI models trained on data classified as "core data" under China's Data Security Law (a category referring broadly to data bearing on national security interests, generally accessible only to the Chinese government or authorized bodies); AI agents used solely or primarily in national critical infrastructure, national defense, or core government systems; AI technologies with strong cyber offensive capabilities; and high-performance AI detection and identification technologies.

The restricted category — license required, automatic licensing potentially available — includes AI large models that meet any of these thresholds: training compute reaching 10²⁶ FLOPs, at least 2 trillion parameters, or globally advanced capabilities (such as ranking among the top 10 in public benchmarks). Also restricted: high-performance AI agent technologies not otherwise prohibited, AI chip and advanced memory chip design technologies, large-scale AI computing clusters of 10,000 or more AI accelerator cards, AI-enabled cybersecurity technologies, and information processing technologies including speech and voiceprint recognition and Chinese-language translation.

Two carve-outs apply across the AI sector. First, any AI technology that has already entered the public domain through open-source release or academic publication is outside the scope of controls entirely. Second, and importantly for enterprises: providing overseas users with access to AI models deployed in China through API access, web or application interfaces, SaaS, or lightweight on-device deployment is not considered a technology export and falls outside the scope. Deploying Chinese AI model weights outside China — moving the model itself — is within scope.

Biomedicine: 5 Technologies

The biomedicine entries are the most directly relevant to healthcare organizations, their research partners, and their biopharma supply chains.

Three technology areas are proposed: cell and gene therapy technologies, small nucleic acid drug technologies (which covers siRNA and related modalities), and pathogenic microorganism technologies.

Pathogenic microorganism technologies are proposed as entirely prohibited — no export license is available regardless of the form of transfer.

For cell and gene therapy and small nucleic acid drug technologies, the framework is more nuanced. The proposed prohibited category covers "technology platforms" — defined as reusable, foundational technologies developed through long-term R&D that can support multiple drug products. The critical carve-out: the prohibition on these platforms applies only to transfers of intellectual property ownership. Licensing, contract research and development, contract manufacturing and production services, and cross-border product-specific collaborations (for R&D, testing, manufacturing, quality control, and regulatory approval of specific drug products) are explicitly excluded from the prohibited category.

The proposed restricted category covers more targeted technologies, including novel target discovery and validation (where "novel" means not previously publicly disclosed anywhere in the world). These restricted technologies remain subject to licensing even when the transfer doesn't involve ownership — but automatic licensing may be available where the export is for public health emergencies or humanitarian relief, cross-border joint R&D using overseas resources, or licensing without ownership transfer.

Photovoltaics: 12 Technologies

The 12 photovoltaic entries cover polysilicon manufacturing, wafer manufacturing, and photovoltaic cell manufacturing, plus key and core manufacturing equipment that embeds or supports those technologies. This is a healthcare-adjacent supply chain consideration given the intersection of solar energy and healthcare facility infrastructure, but it is not a direct healthcare compliance concern for most health systems.

What This Means for Healthcare

The Biopharma and Licensing Supply Chain

The cell and gene therapy and siRNA entries are where healthcare organizations — particularly academic medical centers, research hospitals, and health systems with affiliated biopharma programs — need to focus first.

Cell and gene therapy is a high-growth therapeutic area with significant Chinese research capacity. US and European companies have entered licensing agreements, co-development arrangements, and technology transfer deals with Chinese counterparts over the past decade. If any of those arrangements involve what Notice 48 would classify as a "technology platform" — foundational, reusable technology supporting multiple products — and if those arrangements involve transferring IP ownership from a Chinese entity to a foreign party, registration is required now, and a license may be required once the revised catalogue takes effect.

The carve-out structure is meaningful: licensing and CRO/CMO relationships that do not transfer ownership remain outside the prohibited category. But they are not necessarily outside the restricted category, and the difference matters for compliance planning. Healthcare organizations and their legal counsel reviewing existing or prospective China-linked cell and gene therapy or siRNA arrangements should map the specific form of technology transfer against the proposed framework.

The pathogenic microorganism prohibition warrants particular attention for academic medical centers and public health research institutions with active collaborations involving Chinese partners and pathogen-related research. The proposed scope does not distinguish between benign research collaborations and sensitive dual-use transfers — pathogenic microorganism technologies are proposed as categorically prohibited from export. The comment period through November 15 is the appropriate forum to raise scope concerns about legitimate public health research, though institutions should not wait for the final catalogue to conduct their compliance reviews.

AI Vendor and Agent Technology Exposure

The AI entries are relevant to healthcare in a different way. Health systems are not typically in the business of exporting Chinese AI model weights. The compliance obligation in the direct sense falls on Chinese technology companies, not on US healthcare organizations purchasing or licensing their products.

But Notice 48 introduces a third-party risk consideration. A healthcare organization that has licensed, deployed, or integrated a Chinese-origin AI model or agent technology is now operating in an environment where the Chinese exporter of that technology is subject to registration and potentially licensing requirements. The immediate question is not whether the US health system is in compliance — it is whether its vendor is, and whether a licensing disruption or regulatory change would affect continuity of service.

This is the same analysis that underlies broader AI supply chain due diligence, and it is directly relevant to the open-weight model landscape. The open-source carve-out means that Chinese models released as open source before Notice 48's effective date — or after, if released with public-domain intent — are outside the scope. But proprietary Chinese AI models meeting the compute or parameter thresholds, or Chinese AI agent technologies classified as high-performance, are within scope even if accessed by US organizations through indirect channels.

The data sovereignty argument for open-weight models gets an additional dimension here: a model that is genuinely open source and in the public domain is not subject to Notice 48's scope, while a proprietary model from a Chinese developer — however capable — now exists within a regulatory framework that can be adjusted, tightened, or used as a negotiating instrument. Healthcare organizations evaluating Chinese AI model dependencies should factor this into their risk assessments.

The AI agent technology entries are worth specific attention. Notice 48 explicitly proposes "AI agent technology" as a controlled category, with high-performance AI agents that operate in critical infrastructure among the proposed prohibited technologies. The Tencent agent fleet surveillance discussed in a previous post illustrates what Chinese-developed AI agent infrastructure looks like operating at scale in international environments. The export control framing adds a regulatory layer to the technology risk picture: Chinese AI agent technologies, when they meet the high-performance threshold, are now proposed for formal export restriction.

Third-Party Risk for Health Systems

The broadest healthcare exposure from Notice 48 is through the vendor and research partner ecosystem. Health systems do not need direct relationships with MOFCOM-regulated entities for this to matter. A medical device vendor that sources AI technology from a Chinese developer, a contract research organization with China-based R&D, a biopharma partner with Chinese-origin platform technology in its licensing stack, or a cloud provider with China-linked AI infrastructure — any of these supply chain connections could be affected as Notice 48's proposed controls move toward finalization.

Vendor risk management programs should begin incorporating Notice 48 as a due diligence factor for AI and biopharma vendors with Chinese research or development activity. The key questions are straightforward in concept if not always in practice: Does this vendor have Chinese-developed technology in its product stack? If so, does it meet the thresholds that would make it a controlled technology under the proposed framework? Is the vendor's IP ownership structure one that involves transfers to foreign entities? Has the vendor assessed its registration obligations?

These are not hypothetical questions for a distant future regulatory environment. The temporary registration requirement is in effect today.

What Remains Unknown

Several important things are not yet determinable from the available sources.

The specific technical definitions and quantitative thresholds in Annex 1 are available only from the .wps file attached to the MOFCOM notice. This post cannot characterize those definitions beyond what the notice text and MOFCOM's spokesperson statements confirm. Companies assessing whether their specific technologies meet the 10²⁶ FLOP threshold, the 2 trillion parameter threshold, or the "globally advanced capabilities" standard need to review Annex 1 directly or through legal counsel.

The final scope of the revised catalogue is unknown. Notice 48 is a proposal and a comment period, not a final regulation. The comment period closes November 15. The final catalogue revision date has not been announced. The temporary registration requirement bridges the gap, but the final framework — including how the proposed prohibited and restricted categories are ultimately drawn — remains to be determined.

How MOFCOM will implement the "automatic licensing" mechanism is not yet specified. The Baker McKenzie analysis notes this mechanism does not currently exist in the regulatory framework for technology exports and will require further rules or guidelines. For healthcare biopharma licensing deals that might qualify for automatic licensing, the practical pathway is not yet defined.

Enforcement posture against foreign entities is not addressed in the notice. Notice 48 creates obligations for Chinese technology exporters. What follow-on scrutiny, if any, would apply to foreign enterprises that receive controlled technology transfers without proper registration or licensing is not specified.

What to Watch

The comment period through November 15 will generate industry and government responses that may signal how the final catalogue will differ from the proposal. Academic medical centers and research institutions with China-linked pathogen research partnerships, and biopharma companies with Chinese cell and gene therapy or siRNA platform arrangements, have standing to comment and an interest in how the scope definitions are finalized.

The automatic licensing mechanism details, when released, will clarify the practical compliance pathway for restricted technology licensing arrangements — including the public health emergency and humanitarian relief carve-outs that are directly relevant to the global health research community.

MOFCOM's enforcement posture on the temporary registration requirement will become clearer over the next several weeks. Whether regulators treat this as a formality or a substantive compliance checkpoint will shape how aggressively Chinese technology exporters — and their foreign partners — treat the obligation.