Published on

February 24, 2026

Last updated on

February 26, 2026

Guangdong MPA Publishes 2025 GBA Connect Scheme Medical Products Catalogue

On February 2, 2026, the Guangdong Provincial Medical Products Administration (GDMPA) and the Guangdong Provincial Health Commission published the updated “Catalogue of Urgently Needed Drugs and Medical Devices Imported from Hong Kong and Macao” for use in the nine mainland Greater Bay Area (GBA) cities under the HK–GBA Connect pathway.

Effective immediately, the 2025 edition replaces the prior list and further streamlines access to advanced therapies and medical technologies through Guangdong’s province-level process.

At a Glance: What The 2025 Catalogue Update Changes for GBA Imports

The February 2026 update is effective immediately and replaces the prior list. For designated hospitals and suppliers, the update clarifies which Hong Kong- or Macao-authorized products may be imported and used under the Guangdong province-level process.

Key points include:

Catalogue scope: The 2025 catalogue lists 115 products in total — 45 drugs and 70 medical devices — and the 2024 catalogue is repealed upon release
Governance: The Catalogue operates under Guangdong’s Catalogue Management Measures (in force November 1, 2025), featuring a pre‑review database, expert evaluation, and dynamic additions/removals.
Legal basis: Guangdong’s Administrative Regulations enabling the HK–GBA pathway have been in force since December 1, 2024 across all nine mainland GBA cities.
Uptake versus listing size: As of December 10, 2025, 63 drugs and 77 devices had been approved for use across 71 designated institutions. This cumulative figure differs from the current catalogue size because products may be delisted after obtaining nationwide NMPA approval.

Regulatory Context: What the GBA Connect Scheme Allows

The GBA Connect scheme is grounded in Guangdong’s Administrative Regulations, effective December 1, 2024. It permits designated hospitals in Guangzhou, Shenzhen, Zhuhai, Foshan, Huizhou, Dongguan, Zhongshan, Jiangmen, and Zhaoqing to apply through a Guangdong province-level process to import and use urgently needed drugs and medical devices already authorized in Hong Kong or Macao.

Within this structure, the catalogue functions as the eligibility gate.

How the GBA Connect Scheme Functions as a China Strategy Bridge

Beyond its regulatory mechanics, the pathway also has strategic implications for overseas manufacturers evaluating China entry.

Because it operates within a defined geography and hospital network, HK–GBA Connect Scheme can provide a controlled, lower-commitment route into mainland clinical use. It enables limited deployment without:

Immediate national NMPA marketing authorization
Nationwide distribution obligations
A full China commercial infrastructure buildout
An upfront all-China launch strategy

When a product is listed in the Catalogue, hospitals have a clear compliance basis to request it. Real-world use (especially in specialist centers) can then support evidence generation and adoption ahead of future NMPA submissions by helping companies:

Build China-relevant real-world proof points under local clinical practice
Demonstrate fit with clearly defined unmet need
Strengthen relationships with KOLs and hospital decision-makers
Narrow the evidence distance between global data and China expectations

In this way, the catalogue operates not only as an access mechanism but also as a structured stepping stone toward broader NMPA engagement.

Key Dates Framing Implementation

The 2025 catalogue update sits within a clearly sequenced regulatory timeline:

July 31, 2024 — Guangdong Regulations adopted (effective December 1, 2024).
November 1, 2025 — “Catalogue Management Measures” take effect (dynamic, expert-led selection).
February 2, 2026 — 2025 catalogue published online with 115 items; 2024 catalogue repealed.

The November 2025 Measures are particularly significant. They institutionalize the dynamic nature of the catalogue — including the possibility of delisting after nationwide NMPA approval.

Catalogue Insights and Trends in the 2025 Edition

Beyond the headline count, the composition of the 2025 catalogue signals where designated GBA hospitals are seeking near-term access and where overseas manufacturers may gain early traction.

Drug Portfolio: Therapeutic Direction and Clinical Demand

The drug list points to multiple areas where advanced therapies are being prioritized for urgent clinical use in the GBA.

Rare diseases and enzyme replacement: The presence of multiple ERTs and ultra-orphan products (for example, asfotase alfa, elosulfase alfa, galsulfase, velmanase alfa) suggests continued alignment with rare disease treatment gaps.
Oncology breadth: Inclusion spans solid tumors (for example, vismodegib, cabozantinib, elacestrant) and hematology (for example, azacitidine for AML maintenance), consistent with demand in tertiary centers.
Neurology and migraine: Strong representation of CGRP-targeted and gepant therapies (fremanezumab, eptinezumab, rimegepant, atogepant) supports modern prevention and acute treatment strategies.
Immunology and respiratory: Anifrolumab (SLE) and tezepelumab (severe asthma) broaden advanced immunology options, while roflumilast and ensifentrine strengthen COPD maintenance choices.
Women’s health, pediatrics, and fertility: Follitropin alfa/LH combinations and teduglutide (pediatric short bowel syndrome) indicate attention to reproductive and pediatric needs, while fezolinetant addresses menopausal vasomotor symptoms.
Emergency and critical care: Listings such as hydroxocobalamin (cyanide poisoning) and adrenaline autoinjectors reinforce acute-care readiness.

These clusters identify where overseas companies can most credibly land and expand—rare diseases, oncology, neurology/migraine, immunology/respiratory, and pediatric‑women’s health are particularly well suited to the GBA on‑ramp.

Device Portfolio: High-end Tertiary Care Platforms

The device list highlights technologies that typically require center-of-excellence capabilities, structured training, and service infrastructure — all areas where the GBA designated hospital network is building scale.

Structural heart and heart failure: TriClip G4, Evolut FX+ TAVR system (and related delivery and loading systems), Impella CP with SmartAssist, and LuXValve Plus reflect depth in valvular and circulatory support innovation.
Electrophysiology and thrombosis: EKOS ultrasound-assisted thrombosis systems, TRUPULSE™ generator plus dual-energy THERMOCOOL™ catheter ecosystems, and coronary atherectomy kits show interventional breadth.
Robotics and minimally invasive surgery: Hugo robotic systems (including instruments and accessories) and da Vinci SP signal ongoing expansion of robotics across multiple specialties.
Ophthalmology and ENT hearing: Cochlear implants, auditory brainstem implants, and glaucoma drainage systems point to complex sensory disorder demand.
Advanced diagnostics: BioFire multi-pathogen PCR panels (respiratory, GI, bloodstream) and ALEX³ allergy panels (with MAX 9k analyzer) expand rapid, syndrome-based diagnostics capacity.
GI motility and functional imaging: EndoFLIP™ platforms and balloons support functional lumen imaging applications for esophageal and gastric outlet disorders.

These ecosystems require center‑of‑excellence collaboration, training, and service—precisely where the GBA network is expanding.

De-Listed Products and What “Success” Can Look Like

Under the dynamic management framework, delisting does not necessarily signal reduced demand. In many cases, products may exit the catalogue after securing nationwide NMPA approval — often the intended trajectory.

Examples include:

Delisted Devices

Pulsed field ablation systems (FARAWAVE™ catheter plus FARASTAR™ generator) — described as NMPA-approved for paroxysmal AF, with follow-on products also progressing.

Leadless pacemaker (AVEIR™) — described as expanding adoption, but national NMPA status should be confirmed before making commercialization claims.

SpaceOAR™ — described as supported by China real-world work, with NMPA status treated as “to be verified” at publication time.

Delisted Pharmaceuticals

Lorlatinib (ALK) — described as NMPA-approved with published real-world outcomes.
Entrectinib (ROS1/NTRK) — described as NMPA-approved, with approvals initiated in 2022 and subsequent updates in 2024.
Polatuzumab vedotin (DLBCL) — described as NMPA-approved for combination use in multiple settings.
Inclisiran (siRNA LDL-C) — described as NMPA-approved, illustrating that non-oncology innovation can also “graduate” from pilot access to national availability.

Next Steps for Overseas Manufacturers

The 2025 catalogue creates an operationally usable pathway, but outcomes still depend on disciplined execution across hospital selection, application quality, and evidence planning.

Treat the GBA Connect Scheme as a Low‑Risk, High‑Control Entry Path

The 2025 Catalogue provides pre‑defined, government‑endorsed pathways for bringing innovative drugs and devices into Mainland clinical use without needing initial NMPA approval. For overseas companies unfamiliar with China’s regulatory system, this creates a safe, stepwise route to enter the market while maintaining control over pace, scope, and evidence generation.

Use Hong Kong and the GBA as a Demonstration Zone Before National Rollout

Hong Kong’s internationally aligned systems (e.g., MDACS, EU/US‑recognition, hospital standards) combined with GBA designated hospitals allow companies to:

Pilot market access
Build clinician familiarity
Generate China‑relevant clinical usage experience
Test commercialization strategies in a manageable, geographically concentrated region

This avoids the complexity and cost of launching directly across China’s vast, diverse hospital landscape.

Learn from Products That Successfully “Graduated” from the GBA Pathway

Several products initially introduced via the GBA pathway have subsequently obtained NMPA approval, scaled across China, and been removed from the catalogue as a result. These include several oncology drugs, neurological treatments, and high‑end interventional devices.

Their trajectory demonstrates that the GBA scheme is a proven catalytic platform for broader China entry.

Final Thoughts

The 2025 edition signals clear opportunity clusters for overseas innovators:

Rare disease therapies
Oncology and hematology drugs
Neurology and migraine treatments
Advanced cardiovascular and structural heart devices
Interventional cardiology and electrophysiology platforms
High-end diagnostic panels and functional imaging systems
Surgical robotics and minimally invasive enabling technologies

For companies active in these areas, HK–GBA Connect can function as a focused first landing point in mainland China. Used strategically, it can accelerate patient access and support real-world evidence generation ahead of — or alongside — national filings.

However, the scheme’s dynamic adjustments and hospital-driven workflows require continuous monitoring and precise execution.

Cisema provides end‑to‑end support, from portfolio fit assessment and hospital engagement to application packaging, RWD study design, and NMPA strategy — so you can convert catalogue eligibility into sustained clinical use and nationwide success.

Explore our HK–GBA Connect Scheme services for drug registration and medical device listing, or contact Cisema today to prioritize target hospitals and design effective RWD strategies — supporting your pathway into the GBA and broader China market.