Administrative Measures on Internet-based Drug Information Services
Source:
Effective Date: 11-17-2017
Chinese Title: 国家食品药品监督管理总局(已撤销)
(Promulgated under the Decree No.9 of the China Food and Drug Administration on July 8, 2004; and amended in accordance with the Decision on Revising Some Rules at the executive meeting of the China Food and Drug Administration on November 7, 2017)
Article 1 The present Measures are enacted in accordance with the Drug Administration Law of the People’s Republic of China and the Administrative Measures on Internet-based Information Services for the purpose of strengthening the supervision and administration of drugs, regulating activities relating to internet-based drug information services, and ensuring the authenticity and accuracy of the internet-based drug information.
Article 2 Any activity of providing internet-based drug information services within the territory of the People’s Republic of China is subject to the present Measures. For the purpose of the present Measures, internet-based drug information services refer to service activities of providing online users with drug (including medical devices) information via Internet.
Article 3 Internet-based drug information services are divided into two categories: for-profit purpose and non-for-profit purpose. For the purpose of the present Measures, the for-profit internet-based drug information service refers to the activities which provide online users with paid drug information and other services via the Internet.
For the purpose of the present Measures, the non-for-profit internet-based drug information service refers to the activities which provide online users with public and shared drug information and other services via the internet for free.
Article 4 The China Food and Drug Administration supervises and administers all websites which provide internet-based drug information services nationwide. The food and drug authorities of provinces, autonomous regions and centrally administered municipalities supervise and administer the services which provide internet-based drug information services within their respective administrative regions.
Article 5 Any website intending to provide internet-based drug information services shall, prior to applying for a business license or going through the formalities for record-filing with the competent information industry department under the State Council or the provincial telecommunications authorities, submit an application to the food and drug authority of the province, autonomous regions or the centrally administered municipality where the sponsor of the website is located under the principle of territorial regulation. The website may obtain the qualification for providing internet-based drug information services upon examination and approval by the aforesaid competent authority.
Article 6 The food and drug authority of a province, autonomous region or centrally administered municipality shall review the application for the provision of internet-based drug information services filed by a website within its jurisdiction, and issue Qualification Certificate for Internet-based Drug Information Services to the qualified applicant.
Article 7 The format of the Qualification Certificate for Internet-based Drug Information Services shall be determined by the China Food and Drug Administration in a unified manner.
Article 8 Any website providing internet-based drug information services shall post the number of the Qualification Certificate for Internet-based Drug Information Service in a prominent place on its homepage.
Article 9 The drug information released on a website which provides internet-based drug information services shall be accurate on a scientific basis, and shall be in compliance with the laws and regulations of the State and the relevant provisions of the State governing drug and medical device administration.Websites that provide internet-based drug information service may not publish any product information concerning narcotic drugs, psychotropic drugs, medical toxic drugs, radiopharmaceuticals, addiction medications and preparations made by medical institutions.
Article 10 Any drug (or any medical device) advertisement published by a website that provides internet-based drug information services shall be examined and approved by the food and drug authorities.Any drug (or any medical device) advertisement published by a website that provides internet-based drug information services shall indicate the advertisement approval number.
Article 11 In addition to meeting the requirements stipulated in the Administrative Measures on Internet-based Information Services, any application for providing internet-based drug information services shall satisfy the following requirements:
(1) The provider of internet-based drug information services shall be an enterprise, public institution or any other organization established in accordance with law;
(2) Having professionals, facilities and related systems that are suitable for carrying out internet-based drug information service activities;
(3) Having two or more pharmacy or medical device technicians who are familiar with laws and regulations concerning the administration of drugs and medical devices and professional knowledge of drugs and medical devices, or whose qualification is accredited according to law.
Article 12 Any application for providing internet-based drug information services shall take one website as the basic unit.
Article 13 To apply for the provision of internet-based drug information services, the Application Form for Internet-based Drug Information Service which is prepared and issued by the China Food and Drug Administration in a unified manner shall be completed and filed with the food and drug authority of the province, autonomous region or centrally administered municipality where the sponsor of the website is located, and the following materials shall be submitted as well:
(1) a photocopy of the business license of the applicant;
(2) certificate of registration for domain name or supporting document thereof. Except for bearing the same name as that of the sponsor, the Chinese name of the website dedicated to internet-based drug information services shall not be entitled “zhonguo” (means “China”), “zhonghua” (means “China”) or “quanguo” (means “nationwide”), etc. in Chinese character; except for the website developed by the entity which has obtained the credentials as a drug bidding agency, the name of any other website which provides internet-based drug information services shall not contain the Chinese characters of “e-commerce”, “pharmaceutical investment”, “drug bidding”, etc.;
(3) setup instructions of the sections contained in the website (for the website that applies for for-profit internet-based drug information service, an instruction of the charged sections and charging methods shall be provided);
(4) an explanation of the relevant administrative systems for the backup and availability of the released information on the website and the implementation of the aforesaid systems;
(5) methods and operation instructions for the food and drug authorities to browse the sections and content of the website;
(6) photocopies of the academic certificates or of the certificates of professional qualification for the technicians in drug and medical devices specialty, photocopy of the identity card and resume of the person in charge of the website;
(7) sound measures for network and information security, including website security measures, management system for information security and confidentiality, and user information security management system; and
(8) management measures for the insurance of the legality, authenticity and security of the source of drug information, and the explanation and relevant document thereof.
Article 14 The competent food and drug authority of a province, autonomous region or centrally administered municipality shall make a decision on whether to accept the application within 5 days from the date of receiving the application materials. It shall issue a notice of acceptance to the applicant if accepting the application; in case of refusal, it shall notify the applicant in writing and explain the reasons therefor, informing the applicant of the entitlement to apply for administrative reconsideration or bring an administrative lawsuit.
Article 15 Where the application materials are not normative and complete, the food and drug authority of the province, autonomous region or centrally administered municipality shall inform the applicant once and for all of all the contents that need to be corrected within five days from the date of application; in case of a failure of being notified within the time limit, the application is deemed to be accepted from the date of receipt of the materials.
Article 16 The food and drug authority of the province, autonomous region or centrally administered municipality shall review the application materials for the provision of internet-based drug information services within 20 days from the date of acceptance, and make a decision of approval or disapproval. Where it is approved, the said authority shall issue the Qualification Certificate for Internet-based Drug Information Services, file for record with the China Food and Drug Administration at the same time and make an announcement thereon; in case of disapproval, the said authority shall notify the applicant in writing and explain the reasons therefor, informing the applicant of the entitlement to apply for administrative review or bring an administrative lawsuit.The China Food and Drug Administration shall supervise the examination and approval conducted by food and drug authorities of provinces, autonomous regions and centrally administered municipalities.
Article 17 The Qualification Certificate for Internet-based Drug Information Services shall be valid for 5 years. Where there is any need to continue internet-based drug information services at the expiration thereof, the certificate holder shall apply to the original certificate-issuing authority for the renewal within 6 months before the expiration thereof. The original certificate-issuing authority shall, upon review, issue a new certificate if it considers the applicant is qualified, or send a notice of no disapproval, with reasons therefor stated to the applicant, and the authority originally issuing the certificate shall take back the original Qualification Certificate for Internet-based Drug Information Services and announce the deregistration thereof.The food and drug authority of a province, autonomous region or centrally administered municipality shall, according to the application submitted by an applicant, make a decision on whether to grant the replacement before the expiration of the Qualification Certificate for Internet-based Drug Information Services. In case of failure to make such decision within the time limit, it is deemed to approve the replacement.
Article 18 The Qualification Certificate for Internet-based Drug Information Services may be taken back by the original certificate-issuing authority upon the written application filed by an internet-based drug information services provider. The said authority shall file such take-back for record with the China Food and Drug Administration and make an announcement thereon. The website whose Qualification Certificate for Internet-based Drug Information Services has been taken back shall not continue providing internet-based drug information services.
Article 19 Where an internet-based drug information service provider changes any of the following items, it shall apply to the original certificate-issuing authority for completing the formalities for the change, filling in the Application Form for the Changes to Internet-based Drug information Services, and providing the following relevant supporting documents:
(1) items of the Qualification Certificate for Internet-based Drug Information Services which have been examined and approved (including the name of internet-based drug information services provider, the name of the website, IP address, etc.);
(2) the basic items relating to internet-based drug information services provider (including address, legal representative, the person in charge of the enterprise, etc.); and
(3) the basic information regarding the provision of internet-based drug information services by the website (including service mode, service items, etc.).
Article 20 The food and drug authority of a province, autonomous region or centrally administered municipality shall make a decision on whether to approve an application for the change within 20 working days from the date of acceptance. If the application is approved, the result of the change shall be published and filed with the China Food and Drug Administration for record. In case of disapproval, the applicant shall be notified in writing with the reasons therefor stated.
Article 21 The food and drug authority of a province, autonomous region or centrally administered municipality shall publish the examination and approval process and the result thereof when examining an application. The applicant and the interested parties may submit written opinions on matters directly related to their major interests for statements and defense. Where a hearing is required according to law, a hearing shall be held under legal procedures.
Article 22 In the case of any engagement in internet-based drug information services without obtaining or making use of the Qualification Certificate for Internet-based Drug Information Services beyond the period of validity thereof, the China Food and Drug Administration or the food and drug authority of a province, autonomous region or centrally administered municipality shall issue a warning and order the parties concerned to suspend from engaging in any internet-based drug information service; if the circumstances are serious, the case shall be referred to relevant departments for punishment in accordance with the relevant laws and regulations.
Article 23 Where an website providing internet-based drug information services fails to post the number of the Qualification Certificate for Internet-based Drug Information Services on the prominent position of its homepage, the China Food and Drug Administration or the food and drug authority of the province, autonomous region or centrally administered municipality concerned shall give it a warning, and order it to correct within a time limit; in the case of refusal to make correction within a specified period of time, the website that provides non-for-profit internet-based drug information services shall be imposed a fine of not more than 500 yuan, and for the website that provides for-profit internet-based drug information services, a fine of not less than 5,000 yuan but not more than 10,000 yuan shall be imposed.
Article 24 Where a provider of internet-based drug information services violates the present Measures under any of the following circumstances, it shall be given a warning and ordered to make corrections within a time limit by the China Food and Drug Administration or the food and drug authority of the province, autonomous region or centrally administered municipality concerned. If the circumstances are serious, a fine of not more than 1,000 yuan shall be imposed on the website that provides non-for-profit internet-based drug information services, and a fine of not less than 10,000 yuan but not more than 30,000 yuan shall be imposed on the website that provides for-profit internet-based drug information service; if a crime is constituted, the case shall be referred to the judicial authorities for investigation of criminal liability.
(1) Having obtained the Qualification Certificate for Internet-based Drug Information Services, but the drug information it provides directly match the online drug trading;
(2) Having obtained the Qualification Certificate for Internet-based Drug Information Services, but internet-based drug information services it provides are beyond the approved scope;
(3) Providing false internet-based drug information services and causing adverse social influences; and
(4) Changing internet-based drug information service items without authorization.
Article 25 Where an internet-based drug information service provider illegally uses the Qualification Certificate for Internet-based Drug Information Services in its business activities, the China Food and Drug Administration or the food and drug authority of the province, autonomous region or centrally administered municipality concerned shall impose penalties in accordance with the provisions of relevant laws and regulations.
Article 26 Where the food and drug authority of a province, autonomous region or centrally administered municipality illegally approves an application for provision of internet-based drug information services, the original certificate-issuing authority shall revoke the Qualification Certificate for Internet Drug Information Services which have been previously approved, and where the legitimate rights and interests of the applicant thus are damaged, the original certificate-issuing authority shall make compensation in accordance with the provisions of the State Compensation Law; and the person directly in charge and other directly liable personnel shall be imposed administrative penalties according to law by their employer or the superior authority.
Article 27 The food and drug authorities of provinces, autonomous regions and centrally administered municipalities shall supervise and inspect the websites that provide internet-based drug information services, and make announcements to the public about the results thereof.
Article 28 The present Measures shall be interpreted by the China Food and Drug Administration.
Article 29 The present Measures shall come into force as of the date of promulgation, simultaneously repealing the Provisional Regulation on Internet-based Drug Information Services (Decree No.26of the China Food and Drug Administration).