互联网药械信息服务备案管理规定出台

Core Viewpoint - The National Medical Products Administration (NMPA) has released the "Regulations on the Filing Management of Internet Drug and Medical Device Information Services" to standardize the filing of internet drug and medical device information services and enhance management in this sector [1][2]. Group 1: Regulations Overview - The regulations apply to activities providing drug and medical device information services via the internet within the People's Republic of China [1]. - The regulations specify the content, conditions, procedures, and required documentation for filing internet drug and medical device information services [1][2]. Group 2: Filing Requirements - Information service providers must file using websites, clients, or applications and comply with the "Internet Information Service Management Measures" [1]. - Providers must be legally established entities and have qualified personnel, facilities, and management systems in place [1][2]. - At least two professionals familiar with relevant laws and regulations must be employed by the information service provider [1]. Group 3: Documentation and Compliance - Providers must submit documentation to the provincial drug supervision management department for filing, including qualifications of technical personnel and measures ensuring the legality and safety of information sources [2]. - The filing documentation must be legal, truthful, accurate, complete, and traceable [2]. - Providers are required to appoint a compliance officer to regularly check the information posted on their platforms [2]. Group 4: Monitoring and Enforcement - The drug supervision management department will utilize digital and intelligent methods to monitor the information provided by internet services [2]. - The regulations outline measures for dealing with violations of the filing requirements [2].