（粤港澳大湾区）“ 港澳药械通”目录管理办法发布

Core Points - The Guangdong Provincial Drug Administration and the Guangdong Provincial Health Commission have released a management method for the "Hong Kong-Macao Drug and Medical Device Access" policy, aimed at regulating the import of urgently needed drugs and medical devices from Hong Kong and Macao in the Greater Bay Area [1][2] - The policy allows designated medical institutions in the Greater Bay Area to use urgently needed drugs and medical devices that have been approved in Hong Kong and Macao, enhancing healthcare access for residents [1] - As of September 10, 2023, the policy has expanded to 45 medical institutions, covering all nine cities in the Greater Bay Area, with a total of 125 drug and medical device varieties introduced, benefiting over ten thousand patients [1] Management Method Details - The management method includes a clear "positive and negative list" for the selection of drugs and medical devices, ensuring that only those meeting clinical urgency and safety standards are included, while those with serious safety risks or legal/ethical violations are excluded [2] - A dynamic adjustment mechanism for the directory will be implemented, allowing real-time updates based on the market status of drugs and medical devices, approval status in Hong Kong and Macao, clinical urgency, and safety monitoring results [2] - The management method will take effect on November 1, 2023, and will be valid for five years [3]