What is China’s Internet Drug Information Service License and Who Needs One?
The Internet Drug Information Service License (互联网药品信息服务许可证) is a crucial permit for businesses providing drug-related information services online in China. Issued by the National Medical Products Administration (NMPA), this license is required for companies operating pharmaceutical e-commerce platforms, medical information websites, telemedicine services, or digital health applications that provide drug information. At AppInChina, we provide expert guidance to navigate this complex licensing process, helping you build a compliant foundation for success in China’s healthcare sector.
What is the Internet Drug Information Service License?
The Internet Drug Information Service License authorises businesses to provide drug information services through internet platforms, as regulated under the Administrative Measures for Internet Drug Information Services. This encompasses pharmaceutical e-commerce platforms, medical consultation websites, drug database services, telemedicine applications, and digital health platforms that offer medication guidance or pharmaceutical product information. Valid for five years, the license requires renewal applications to be submitted 90 days before expiry. Any business providing drug information services to Chinese users, whether through direct consultation, database access, or integrated e-commerce functionality, must obtain this permit to operate legally.
It is worth noting that, much like the ICP License, this license is split into two categories: commercial (经营性) and non-commercial (非经营性). Therefore, entities providing information and engaging in commercial activities will require the commercial license, whereas entities only providing information will require the non-commercial license.
Why Do You Need This License?
The Internet Drug Information Service License ensures your business complies with China’s strict pharmaceutical regulations, enabling legal provision of drug information services. The license number must be prominently displayed on your website and mobile applications. Operating without an Internet Drug Information Service License carries severe penalties, including mandatory cessation of operations and potential confiscation of all illegal revenue, depending on the severity of the violation. Fines of 1000 CNY can be applied to violations of the non-commercial nature and up to 30,000 CNY for commercial violations. Additionally, unlicensed operators may face criminal liability under China’s Drug Administration Law.
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Obtain the Internet Drug Information Service License by parterning with AppInChina!Who Needs the Internet Drug Information Service License?
Any business providing drug information services to Chinese users requires this license. As mentioned, this includes pharmaceutical e-commerce platforms selling prescription or over-the-counter medications; telemedicine platforms offering online consultations with prescription capabilities; medical information websites providing drug databases or interaction checkers; digital health applications with medication reminders or dosage guidance; and healthcare platforms facilitating doctor-patient communication about medications.
Medical device companies with drug-related components and international pharmaceutical companies establishing a digital presence in China also fall under this requirement. Companies providing purely general health information without specific drug guidance may qualify for simplified registration, but most digital healthcare businesses targeting China’s market need the full license to operate effectively and build consumer trust.
How Can I Obtain This License?
Securing an Internet Drug Information Service License involves a rigorous process with stringent requirements. The fundamental requirement is that businesses must establish a legal entity in China with proper pharmaceutical qualifications.
Applications are submitted to provincial health authorities and undergo a 45-day initial review before forwarding to the National Medical Products Administration for final approval, which typically requires an additional 30 days. For domestic companies, the complete process takes 2-4 months and costs between RMB 25,000 and 60,000, depending on regional variations and the complexity of services offered.
Required Application Documents:
- Application Form for Internet Drug Information Service Qualification License
- Copy of business license (营业执照)
- Certificate or supporting document of domain name registration
- Website column setting instructions
- Description of the relevant management system and implementation of the website for backing up and consulting historical information
- Methods and operation instructions for food and drug supervision and administration departments to browse all columns and contents on the website online
- Copy of at least two academic certificate or professional qualification certificates of pharmaceutical and medical device-related professional and technical personnel, copy of ID card (身份证) of the person in charge of the website
- Sound network and information security measures, including website security measures, information security and confidentiality management systems, user information security management systems
Additional Supporting Documentation:
- Detailed business plan outlining drug information services
- Financial statements and funding source verification
- Articles of association and corporate structure documentation
- Proof of office space usage rights and operational facilities
- Server location and data storage compliance documentation
- Quality control procedures for drug information accuracy
- Emergency response plans for adverse drug reaction reporting
For specialised services such as prescription drug sales or controlled substance information, additional approvals from relevant health authorities are required. Licensed businesses must display their permit number prominently and may need supplementary permits, such as the Internet Hospital License or Medical Device Business License, depending on their service scope. AppInChina streamlines this complex process, managing all documentation requirements and regulatory coordination to minimise delays and ensure compliance.
Can I Obtain this License as a Foreign Company?
Wholly Foreign-Owned Enterprises (WFOEs) cannot directly obtain Internet Drug Information Service Licenses due to strict foreign investment restrictions in healthcare services. Foreign companies must establish partnerships with qualified Chinese entities, such as AppInChina, or implement Variable Interest Entity (VIE) structures to access this market legally. Additional challenges include language barriers in technical documentation, complex regional regulatory variations, and stringent professional qualification requirements for staff.
The regulatory landscape requires deep understanding of China’s pharmaceutical laws, data localisation requirements, and cross-border data transfer restrictions. AppInChina offers comprehensive solutions, including local partnership facilitation, regulatory compliance consulting, and complete localisation services to ensure your drug information services meet Chinese standards while maintaining operational control of your business interests.
How Can AppInChina Help?
AppInChina provides comprehensive end-to-end services to secure your Internet Drug Information Service License and establish a strong presence in China’s digital healthcare market. Our experienced team manages the entire licensing process, from initial consultation and document preparation to submission, follow-up, and post-approval compliance support. We ensure adherence to the latest NMPA regulations and provincial requirements while minimising processing time and regulatory risks.
Ready to enter China’s digital healthcare market? Contact us today to secure your Internet Drug Information Service License and establish a compliant, successful healthcare business in China.