New Greater Bay Area regulations for importing Hong Kong drugs and medical devices have been approved by the Standing Committee of the 14th Guangdong Provincial People’s Congress on July 31, 2024. These regulations will come into effect on December 1, 2024. The Regulations on the Administration of Import of Drugs and Medical Devices from Hong Kong and Macao into the Nine Cities in the Guangdong-Hong Kong-Macao Greater Bay Area of Guangdong Province are designed to streamline and enhance the management of urgently needed imports from Hong Kong or Macao as part of the HK-GBA connect scheme introduced a few years ago. The connect scheme aims to address the medical needs of residents in the nine mainland cities of the GBA, ensuring the safety, effectiveness, and traceability of these products.
Streamlined Application Review Process (Article 9)
The regulation introduces a more efficient review process for the importation of urgently needed drugs and medical devices. For items listed in the import catalogue, the review process will be shortened to 10 working days. For non-listed items, the review period will be shortened to 20 working days. This expedited process is designed to facilitate quicker access to necessary medical products, thereby improving healthcare services in the region.
Standardization and Management Systems (Article 11)
To ensure the safety and quality of imported drugs and medical devices, the regulation mandates the establishment of comprehensive systems for safety alerts, recalls, and traceability. This requirement is in line with the province’s enhanced supervision measures to ensure that all imported medical products adhere to stringent safety standards, safeguarding public health.
Optimized Customs Clearance Procedures (Article 13):
The new regulation significantly improves the customs clearance process for urgently needed imports. It eliminates the need for port inspections, allowing for faster entry of critical medical products. Additionally, the regulation encourages coordination with customs, civil aviation, and railway authorities to optimize the procedures, further facilitating quick access to essential medical supplies.
Encouragement of Insurance Coverage (Article 22)
The regulation promotes the inclusion of GBA-approved drugs and medical devices in insurance plans. It encourages insurance companies to consider providing coverage for these products and improving compensation procedures, thereby reducing the financial burden on patients and fostering a more inclusive healthcare environment.
Promotion of Real-World Studies (Article 23)
The new regulation supports conducting Real-World Studies (RWS) on GBA-approved drugs and medical devices. Such studies are encouraged to support future National Medical Products Administration (NMPA) registrations and to facilitate the marketing of these products nationwide in other provinces and cities across China. This approach is expected to generate valuable evidence regarding the effectiveness and safety of these products in real-world settings, aiding in broader regulatory approval and adoption.
Guangdong MPA Real-World Study Case Studies for GBA-Approved Products
In alignment with the NMPA Technical Review Guidelines for Real-World Evidence Supporting Drug Development (January 7, 2020), several real-world studies are currently being conducted:
- PROEM Study (April 12, 2024): This study focuses on Lemborexant, a medication for insomnia, to gather real-world evidence about its safety and effectiveness.
- BEST Study (June 6, 2024): This study investigates the use of Brolucizumab for Diabetic Macular Edema, aiming to evaluate its real-world application and potential benefits for broader patient populations.
China NMPA’s recognition of real-world studies is crucial as additional reference that may support the expanded use and registration of these drugs and medical devices in other regions of China.
Further information
Read the original Guangdong MPA announcement on the new Greater Bay Area Regulations. For more information on how these regulatory changes can benefit the market entry of your medical devices or drug products in China, or for assistance with your NMPA registration application, please feel free to contact us.
