The Greater Bay Area (GBA) – with a total population of approximately 71.2 million people (5% of China’s total population) – includes nine mega cities of Guangdong province: Guangzhou, Shenzhen, Zhuhai, Foshan, Dongguan, Zhongshan, Jiangmen, Huizhou, and Zhaoqing. These nine cities are applicable of urgent use policy for medical devices and drugs starting in May 2021.
While not-yet-approved in the mainland, Hong Kong or Macao approved drugs and medical devices can be utilized in GBA. They can be used only if the significant clinical benefits with urgent needs can be demonstrated.
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Guangdong government issued “Administrative Measures for the Catalog of Clinically Urgent Drugs and Medical Devices Imported from Hong Kong and Macao into the Greater Bay Area” on September 15, 2025. The framework is to further streamline the urgent use policy in GBA. It is designed to ensure that residents in the region have timely access to advanced and urgently needed products while maintaining rigorous safety standards.
The Measures will take effect on November 1, 2025, with the validation period of five years.
Principles and Responsible Parties
Catalog formulation must be guided by clinical demand, with transparency and dynamic adjustment. The Guangdong MPA leads the system, supported by the Health Commission and specialized centers responsible for evaluation, adverse event monitoring, and coordination with Hong Kong and Macao regulators.
Entry into Pre-review Database
Article 7 establishes the gateway mechanism for candidate products to enter the evaluation process. Manufacturers are input the information of drugs and devices to the pre-review database, which functions as a repository of potential products to be considered for the urgent catalogue.
- Who can apply:
The responsibility lies with the marketing authorization holders (MAHs) of drugs and devices, or their authorized legal entities within mainland China. - What must be submitted:
Submitters must provide detailed information and supporting documents on products they believe qualify as clinically urgent and suitable for inclusion in the catalog. T - Automatic inclusion in pre-review database:
Once the application is successfully filed and submitted, the product is automatically recorded in the pre-review database. This step does not yet grant inclusion in the official catalog but ensures that the product is under consideration for expert evaluation. - Handling deficiencies:
If submitted materials are incomplete or do not meet requirements, the Guangdong MPA’s Certification and Evaluation Center may either request additional documents from the submitter or remove the product from the database.
Eligibility Criteria
Article 8 defines the criteria products must meet to qualify for catalogue inclusion. Beyond meeting the general definition in Article 2, products must satisfy at least one of four specific conditions:
- Nationally recognized urgent products:
Products already identified by the National Medical Products Administration (NMPA) as clinically urgent foreign drugs or devices, and which are also approved for sale in Hong Kong or Macao. - Rare, innovative, or pediatric needs:
Products already in the pre-review database that address rare diseases, pediatric use, or represent innovative therapies or devices, provided they are clinically urgent and demonstrate advanced clinical applications. - Previously approved imports:
Products that have already obtained approval documents for import into mainland China as clinically urgent HK/Macao drugs or devices. - Other nationally recognized categories:
Any products that fall under other urgent classifications stipulated by national regulations.
Review Procedures
The Certification and Evaluation Center regularly reviews database entries, organizes expert evaluations, and submits recommendations for inclusion. Products with serious safety risks, ethical violations, or non-compliance with laws are ineligible.
Expert Involvement
A pool of evaluation experts is formed from medical, academic, and industry institutions. Catalogue development involves consultation with stakeholders, and the final catalogue is publicly released for use by hospitals and patients.
Rules for Dynamic Adjustment
Products may be removed if approved in mainland China, discontinued in Hong Kong/Macao, lose clinical urgency, or present safety risks. The Adverse Reaction Monitoring Center evaluates safety signals and advises on removals.