According to recent statistics from Guangzhou Customs, the demand for medical products in the Greater Bay Area (GBA) has surged significantly. As of December 2023, the Guangzhou customs authority supervised a total of 155 batches of imported drugs and medical devices from Hong Kong and Macau, with a total value exceeding 21.6 million RMB.
| Date | Drugs | Medical Devices |
| August 27, 2021 | 7 products approved | 2 products approved |
| February 18, 2022 | 6 products approved | 1 product approved |
| July 7, 2022 | 4 products approved | 8 products approved |
| As of February 2023 | Total of 46 batches imported | Total of 15 batches imported |
| April 23, 2023 | 3 products approved | 1 product approved |
| As of August 2023 | Total of 83 batches imported | Total of 21 batches imported |
| September 8, 2023 | 3 products approved | 5 products approved |
| As of December 2023 | Total of 106 batches imported | Total of 49 batches imported |
| January 15, 2024 | 2 products approved | 10 products approved |
This underscores the increasing significance of regulatory compliance for overseas manufacturers aiming to meet entry criteria and maintain competitiveness in the GBA market. Staying abreast of the latest announcements and measures, particularly regarding pricing strategies and marketing approvals, is crucial for navigating this dynamic regulatory landscape.
Upcoming guidelines to facilitate flexibility in pricing strategies
On February 18, 2024, the Healthcare Security Administration of Guangdong Province has issued working guidelines for the implementation of medical service pricing projects under the GBA expedited pathway that will come into effect from March 1, 2024, onwards for 5 years.
Designated institutions will be required to maintain records according to provincial regulations, actively sharing project and pricing details with local authorities. However, they have the autonomy to independently set prices for service items associated with the GBA expedited scheme, drawing upon established practices from the overseas markets to ensure fairness, legality, and credibility. This flexibility allows overseas manufacturers and designated institutions to work together in determining pricing structures that adhere to fair and legal standards, preventing any additional charges beyond approved rates. It’s recommended for overseas manufacturers to collaborate closely with designated institutions to ensure pricing strategies align with mutually agreed expectations during negotiations.
Overview of recent GBA approvals in January 2024
On January 15, 2024, the Guangdong Medical Products Administration (MPA) and the Health Commission of Guangdong Province jointly announced the sixth batch of GBA approved products, consisting of 2 pharmaceuticals and 10 medical devices:
GBA approved pharmaceuticals in January 2024:
- Icosapent Ethyl
- Varenicline solution nasal spray
GBA approved medical devices in January 2024:
- FARAWAVE Pulsed Field Ablation Catheter
- FARADRIVE Steerable Sheath
- FARASTAR Pulsed Field Ablation Generator
- AveirTM Leadless Pacemaker
- AveirTMDelivery Catheter
- AveirTMIntroducer
- AveirTMRetrieval Catheter
- Heli-FX EndoAnchor System Heli-FX Applier with EndoAnchor Cassette
- Heli-FX Ancillary EndoAnchor Cassette
- Heli-FX EndoAnchor System Heli-FX Guide
As of January 8, 2024, a total of 28 medical devices and 28 pharmaceuticals have been approved for importing from Hong Kong and Macau via the GBA expedited scheme for the urgent clinical use in 19 designated institutions, benefiting a total of 4,509 patients.
Further information
Since the GBA expedited pathway’s official implementation in 2021, many foreign manufacturers have leveraged on their Hong Kong and Macau marketing approvals to efficiently distribute pharmaceuticals and medical devices to GBA designated medical institutions. Cisema consistently assists overseas manufacturers with MDACS listing applications for medical devices and new drug applications with the Department of Health to secure market approval in Hong Kong. Should you wish to gain further insight into the application procedure in Hong Kong or the China GBA expedited scheme, please reach out to Cisema.
