China has embraced deregulation in recent years to enable quicker approvals and access for imported treatments
Guangdong–Hong Kong–Macao Greater Bay Area (GBA) “Medicine & Equipment Connect” launched under the November 2020 Work Plan, the scheme lets 45 designated Grade-A hospitals across the nine Guangdong cities import and use drugs already registered in Hong Kong or via Macau’s fast-track pathway for patients whose condition meets the “urgent clinical need” test, without requiring prior NMPA market authorization. Guangdong MPA decides each hospital’s batch-import license within 20 working days, after which treatment can start; real-world evidence generated at the pilot sites may later be submitted to support national registration. Because these products are not yet on China’s reimbursement lists, patients pay out-of-pocket. 97 products, including 49 drugs and 48 devices, have been approved as of December 2024.
Hainan’s Boao Lecheng International Medical Tourism Pilot Zone is a “medical special zone” located on the island of Hainan, in mainland southern China. As of July 1, 2025 it contains 30 private specialty hospitals, 2 public general hospitals and 6 medical service centers (all inside Hainan), giving the zone a network of 30+ clinical providers that can collectively import and use overseas-approved but China-unlicensed drugs and devices. Under the province’s “urgent clinical need” rules, each institution obtains a facility-specific import license from the Hainan MPA; no prior NMPA market registration is required for use within the zone. No local clinical trials are required, and real-world data generated in Hainan may submitted to the NMPA for national approval. 485 products, including 308 devices and 177 drugs, have been approved as of July 1, 2025. Patients pay out-of-pocket.
Nationwide, the 2019 Drug Administration Law and a 29 June 2022 NHC/NMPA work plan let hospitals—after ethics approval—obtain provincial one-off import permits for overseas-approved drugs to treat a named patient with a life-threatening or rare disease lacking domestic options. Article 23 of the same Law also allows trial hospitals to run sponsor-funded post-trial Managed-Access Programs, supplying investigational medicines to additional patients at the site until full NMPA approval.
Named Patient Programs (NPPs) involving gene and cell therapies that necessitate cross-border transport of human biological materials—including cells, blood, or tissue—encounter additional complexities in China. This is due to stringent regulations in mainland China that restrict the international transport of human genetic resources, specifically any biological material from which a significant amount of DNA can be extracted. Consequently, implementing these therapies often requires alternative logistical arrangements through jurisdictions outside of mainland China, such as Macau, Hong Kong or Singapore, to comply with regulatory mandates.
Restrictions on Treatments Involving Cross-Border Transport of Human Tissues and Cells
Under China’s regulatory framework, the cross-border transport of human tissues, cells, blood, or related biological materials is strictly controlled. The Regulations on the Administration of Human Genetic Resources explicitly prohibit the export of such human genetic resources (HGR) from Mainland China without prior regulatory approval. This restriction directly impacts advanced therapies such as CAR-T and other cell/gene therapies, which typically require patient-specific biological material to be transported internationally.
In response, ACA Pharma leverages established treatment centers in jurisdictions outside of Mainland China’s regulatory scope—particularly Macau and Singapore—to facilitate such advanced treatments. Our Macau team previously supported the successful registration of Hengrui’s CAR-T cell therapy for leukemia at Xiehe Hospital (PUMCH Macau). Furthermore, our team has extensive experience in obtaining regulatory clearances and validations for the import of gene and cell therapies through past collaborations with leading institutions, including the Chinese Academy of Sciences.
- Key implications:
- China’s laws prohibit unauthorized export of tissues, cells, and genetic materials.
- Treatments requiring international shipment of biological materials (e.g., CAR-T) must establish centers outside Mainland China, such as in Macau, Hong Kong or Singapore.
- ACA Pharma has significant regulatory expertise and a proven track record facilitating cell and gene therapies through these alternate jurisdictions.
ACA Pharma
End-to-End Commercialization Partner for Greater China and Southeast Asia
Who we are & what we do – A New York headquartered CSO with entities in Macau, Hong Kong and Singapore handling every step from registration, marketing, distribution to sales, under the guidance of former neurologist Mike Zhou and bilingual teams with 30+ years of China pharma experience.
Risk-free model for originators – ACA Pharma funds all regulatory, commercialization and logistics work; originators provide only minimal paperwork and one sample box, retain all IP, invest no capital and begin generating revenue from first shipment. Backed by wholesale-drug, retail-pharmacy and DEA licenses in New York plus compliant entities in Macau, Hong Kong and Singapore.
Two fast tracks to market – The Asian Patient Access Program ships product immediately under compassionate-use permits, while Macau Fast-Track secures full approval in 30–90 days; 54 US/EU medicines have already cleared the pathway (seven more in review) with a documented 100% success rate and no additional clinical trials.
Distribution that scales – After approval in Macau, supply starts immediately to 45 hospitals across the 120M population Greater Bay Area, and can extend to nationwide registration in as little as 3–12 months for orphan or clinically urgent drugs. Revenues flow first via self-pay in mainland China and local insurance in Macau, Hong Kong and Singapore, and later through China’s national reimbursement system.
Wider mainland reach – After Macau approval, pediatric orphan medicines can be listed within weeks in leading hospitals across Beijing, Shanghai, Tianjin, Hainan and Chongqing, and gain entry to China’s 33 top pediatric centers treating over 80% of the country’s pediatric rare-disease patients.