Drugdu.com expert's response:

The issuance of the Administrative Provisions on the Filing of Internet Information Services for Drugs and Medical Devices marks a new phase in China's regulatory efforts to standardize and strengthen oversight of internet-based information services for drugs and medical devices. Its core significance is reflected in the following aspects:

I. Regulatory Framework Upgrade: Decentralized Management Enhances Efficiency

Clarified Division of Responsibilities

National Medical Products Administration (NMPA): Oversees nationwide filing guidance and supervision, establishing unified standards.

Provincial Medical Products Regulatory Authorities: Responsible for specific filings and local supervision, creating a "national coordination + local implementation" model that ensures policy consistency while enhancing regional regulatory flexibility.

Refined Filing Units: Filings are conducted on a per-website or per-app basis to ensure traceability of information on each platform and prevent regulatory gaps caused by "one license for multiple uses."

Strengthened Dynamic Oversight

Real-Time Updates for Filing Changes: Key information, such as the host organization’s name, legal representative, and domain name, must be updated within 10 working days of any changes to prevent regulatory failures due to outdated data.

Regular Review Mechanism: Provincial authorities are required to verify the authenticity of filing materials within three months of submission and conduct on-site inspections when necessary. Non-compliant entities are ordered to rectify issues within a specified period or face cancellation of their filing status.

II. Raised Entry Barriers: From Formal Compliance to Substantive Safety

Strict Control Over Host Organization Qualifications

Only legally established legal entities or other organizations are permitted to file (individual or unregistered entities are prohibited), ensuring traceable accountability.

A minimum of two professionals (familiar with regulations or possessing qualifications in pharmacy/medical device technology) must be employed to guarantee the professionalism of information services.

Rigid Constraints on Information Authenticity

Prohibition on High-Risk Product Information: Platforms are barred from publishing information on vaccines, blood products, narcotics, and other specially controlled drugs, as well as traditional Chinese medicine formula granules and hospital preparations, to prevent public access to illegal or dangerous information via the internet.

Mandatory Information Backup System: Platforms must establish mechanisms to back up and retrieve historically published information, ensuring traceability and verifiability.

III. Protection of Public Interests: From Transparency to Risk Prevention

Enhanced Trust Through Public Display of Filing Numbers

Platforms are required to prominently and continuously display their filing numbers (e.g., "WangYaoXieXinBei (Beijing) Zi [2025] No. 000001") on their homepages to improve transparency and facilitate verification by the public and regulators.

Assigning Compliance Responsibilities to Individuals

Host organizations must designate at least one staff member knowledgeable about regulations to oversee compliance evaluations and conduct regular self-audits of information content to ensure ongoing adherence to national standards.

Advance Notice for Service Termination

If a platform ceases operations, it must announce the shutdown 30 days in advance and complete the cancellation of its filing to prevent user losses from abrupt service interruptions.

IV. Technology-Empowered Regulation: From Manual Inspections to Intelligent Monitoring

Routinized Online Monitoring

Regulatory authorities leverage information technology to monitor platform information in real time, swiftly identifying unfiled platforms, those failing to display filing numbers, or those disseminating prohibited content.

Escalated Penalties for Violations

Entities providing services without filing or disseminating unauthorized information are ordered to rectify issues within a time limit and may face measures such as interviews with legal representatives or public announcements.

Cases involving illegal sales or violations of other laws and regulations are referred to relevant authorities for disposition, forming a closed-loop management system of "filing-monitoring-penalties."

V. Far-Reaching Industry Impact: From Unregulated Growth to Standardized Development

Curbing Illegal Operations

Strict filing requirements and dynamic reviews eliminate unqualified or non-compliant platforms, purifying the market environment.

Driving Corporate Compliance Upgrades

Companies must allocate more resources to meet professional staffing and information backup requirements, compelling industry-wide improvements in management standards.

Fostering a Healthy "Internet + Healthcare" Ecosystem

By ensuring safety, standardized information services facilitate public access to legitimate drug and medical device information, promoting innovation and sustainable development in the sector.

VI. Conclusion

The issuance of these provisions represents a critical step by the NMPA toward implementing "full-chain, dynamic, and intelligent" regulation of internet-based drug and medical device information services. By raising entry barriers, strengthening process oversight, and holding entities accountable, the regulations safeguard public safety while laying a institutional foundation for high-quality industry development. As the provisions are implemented, internet-based drug and medical device information services will enter an era where compliance becomes a core competitive advantage.