On July 31, 2025, China’s National Medical Products Administration (NMPA) commenced soliciting public comments on the “Regulations on the Filing Administration of Internet Drug and Medical Device Information Services (Draft for Comment).” The consultation period is open until August 30, inviting stakeholders and the public to provide feedback on the proposed regulatory framework.
Scope and Regulatory Framework
The draft regulations pertain to the provision of drug and medical device information services to internet users within the People’s Republic of China. The NMPA will oversee and guide these activities at the national level, while provincial, autonomous region, and municipal drug regulatory departments will manage filing and supervision within their jurisdictions.
Requirements for Service Providers
Filing Number Display
Websites and mobile applications offering these services must prominently and continuously display their internet drug and medical device information service filing number on their homepage.
Information Accuracy
Published drug and medical device information must be truthful, accurate, complete, and in compliance with national regulations.
Prohibited Information
Service platforms are prohibited from publishing product information for:
- Specially controlled drugs, including vaccines, blood products, narcotic drugs, psychotropic drugs, toxic medicinal drugs, and radioactive drugs.
- Pharmaceutical precursor chemicals.
- Traditional Chinese medicine formula granules.
- Medical institution preparations.
- Any other drug or medical device information banned by the NMPA.
Compliance Management
Websites and applications must designate at least one manager well-versed in drug and medical device laws and regulations. This manager will oversee compliance and regularly assess the legality of all published information.
Service Termination
Should a platform cease providing these services, it must post a notice on its homepage at least 30 days in advance and file for cancellation with the relevant provincial drug regulatory department.
Regulatory Oversight
Drug regulatory departments are mandated to employ informational, digital, and smart technologies to conduct online monitoring of drug and medical device information published on these platforms, ensuring compliance with the regulations.-Fineline Info & Tech
