By Fineline Cube 
The Guangdong Provincial Drug Administration and the Guangdong Provincial Health Commission jointly announced the “Administrative Measures on the Catalog of Clinically Urgently Needed Imported Drugs and Medical Devices from Hong Kong and Macao for the Nine Mainland Cities in the Guangdong‑Hong Kong‑Macao Greater Bay Area.” The measures will take effect on November 1, 2025 and remain in force for five years.
Key Provisions
- Scope – The catalog lists drugs and devices that are:
- Clinically urgently needed and already marketed in Hong Kong or Macao;
- Included in the National Medical Products Administration’s pre‑review library (e.g., rare‑disease therapeutics, pediatric products, or other innovative technologies);
- Approved for “clinical urgent import” from Hong Kong/Macao; or
- Otherwise compliant with national regulations and deemed clinically advanced.
- Exclusions – Items with confirmed serious safety risks, violations of national law, or lacking ethical compliance will be omitted.
- Dynamic Updating – The catalog will be revised in real time when:
- A product gains mainland China marketing approval;
- Hong Kong/Macao approval is revoked or the device is no longer used by public hospitals;
- Clinical urgency or advancement criteria are no longer met;
- Safety concerns or serious adverse events emerge;
- Fraudulent documentation is discovered; or
- The holder voluntarily requests removal.
Strategic Impact
- Accelerated Access – The framework is expected to shorten the time required for high‑need therapies to reach patients across the Greater Bay Area’s nine mainland cities.
- Regulatory Alignment – By harmonizing Hong Kong/Macao approvals with mainland China’s regulatory environment, Guangdong aims to reduce duplication and streamline supply‑chain logistics.
- Innovation Boost – The inclusion of pre‑review library items encourages the adoption of cutting‑edge rare‑disease and pediatric treatments in the region.-Fineline Info & Tech