Notice of China National Food and Drug Administration on Calling for Comments about Administrative Regulations on the “Black List” of Drug Safety (Trial)
Shi Yao Jian Fa Han [2012] No. 44
Released on May 30, 2012
In order to further improve the drug safety supervision and management, promote the construction of the credit system and strengthen the industry access and exit mechanism, we, in accordance with the regulations of the Administrative Licensing Law of the People’s Republic of China, Regulations on Open Government Information of the People’s Republic of China, etc., organize the formulation of Administrative Regulations on the “Black List” of Drug Safety (Trial) and now are calling for comments from the society on it. Please log on the website of China National Food and Drug Administration (website: http://www.sfda.gov.cn), enter “Asking for Opinions” and click “Calling for Comments about Administrative Regulations on the “Black List” of Drug Safety (Trial)”.
The public can provide feedback through the following channels and ways:
1. E-mail liwx@sfda.gov.cn
2. Fax: +86-10-68311982
3. Address: Law Office of the Policy and Regulation Division, China National Food and Drug Administration, Building 2, Court 26, Xuanwumen West Street, Xicheng District, Beijing
Zip Code: 100053
Feedback Deadline: June 6, 2012
Law Office of the Policy and Regulation Division, China National Food and Drug Administration
May 3, 2012
Administrative Regulations on the “Black List” of Drug Safety (Trial)
(Exposure Draft)
Article 1 In order to further improve the drug safety supervision and management, promote the construction of the credit system and strengthen the industry access and exit mechanism, the Regulations are formulated hereby in accordance with the regulations of the Drug Administration Law of the People’s Republic of China, Administrative Licensing Law of the People’s Republic of China, Regulations on Open Government Information of the People’s Republic of China, Regulations on the Supervision and Management of Medical Devices and other relevant laws and administrative regulations.
Article 2 The Food and Drug Supervision Administration establishes a drug safety “black list” according to the requirements of relevant laws and regulations, publishes the relevant information of the production operator and its direct personnel in charge and other direct responsible personnel (responsible personnel for short) that have received administrative punishment due to serious violation of drug and medical device management laws and regulations through the government affairs website or other ways, has them accept social supervision and strengthen focus supervision.
Article 3 Production operators mentioned in the Regulations include enterprises or other units engaged in the R&D, production, operation and use of drugs and medical devices within the territory of the People’s Republic of China.
Article 4 The drug safety “black list” should be open according to law and published objectively and timely in a fair and impartial principle.
Article 5 China National Food and Drug Administration is responsible for the management of the national drug safety “black list”; and the food and drug administration of all provinces (autonomous regions, municipalities) is responsible for the management of drug safety “black list” in their respective administrative region.
Article 6 China National Food and Drug Administration shall include the production operators and responsible personnel involved in the serious administrative penalty cases it investigates and handles in the drug safety “black list” and publish the “black list” via its government affairs website. All provincial (regional, municipal) food and drug administration shall publish the information of the production operators and responsible personnel involved in the drug safety “black list” in their respective administrative area via their own government affairs websites and report to the National Food and Drug Administration for united publication.
Article 7 Any serious illegal production operator that meets one of the following situations and receives administrative punishment shall be included in the “black list” of drug safety:
(1) Produce and sell counterfeit drugs or the circumstance of producing and selling counterfeit drugs is serious;
(2) Produce medical device without medical device product registration certificate or the circumstance of producing medical devices not in line with national standards or industry standards;
(3) Those that conceal the relevant information and provide false materials in the process of applying for relevant administrative license;
(4) Those that provide false certificates, document samples or take other fraudulent, bribery or other improper means to obtain relevant administrative licensing, approval documents or other qualifications;
(5) Those that produce and sell drugs and medical devices not in line with the quality management practices or other legal conditions and requirements and lead to serious quality safety incidents;
(6) Those that forge or deliberately destroy the scene; transfer, conceal, forge or destroy relevant evidence; refuse to, evade supervision and inspection, or refuse to provide relevant information and materials; and take the liberty of using the sealed or distressed objects;
(7) Those that receive criminal punishment due to drug or medical device related illegal crimes;
(8) Other drug or medical device related illegal crimes with subject intent, serious nature or severe harm.
Those that sell counterfeit drugs or produce and sell bad drugs with serious nature and those responsible personnel not allowed to engage in drug production and operation within ten years should also be included in the “black list”.
Article 8 Where the drug safety “black list” is published, the time limit for prohibiting the production operator with any one of the following circumstances to engage in relevant activities should also be published together:
(1) For production operators with circumstances stipulated in item (3), paragraph 1, article 7 of the Regulations, the Food and Drug Administration can refuse to accept the administrative licensing application they put forward or not grant them administrative licensing. The production operator shall not apply for this administrative licensing within a year; but for those that receive administrative punishment decisions according to Article 70 of the Regulations for Implementation of the Drug Administration Law, their application shall not be accepted within three years.
(2) For production operators with the circumstances stipulated in item (4), paragraph 1, article 7 of the Regulations, in addition to revoking or cancelling their license, approval certificates or other qualifications by the Food and Drug Administration, the production operator shall not apply for this administrative license within three years; but for those that receive administrative punishment decisions according to Article 83 of the Drug Administration Law and Article 75 of the Regulation on the Control of Narcotic Drugs and Psychotropic Drug, their application shall not be accepted within five years. For responsible personnel in line with the circumstances stipulated in paragraph 2, article 7 of the Regulations, drug production operators shall not employ them to engage in drug production and operation within ten years.
Article 9 For those in line with the circumstances stipulated in the article 7 of the Regulations and included in the drug safety “black list”, the National or Provincial (Regional, Municipal) Food and Drug Administration shall publish that via the government affairs website within 15 working days after the administrative penalty decision takes effect.
Article 10 The drug safety “black list” shall be published by the food and drug administration through the government affairs website, news media or press conference. The food and drug administration should set up the drug safety “black list” column in an eye-catching position on the home page of its government affairs website, and arrange specialists to manage and update it timely.
Article 11 Items to be published include the name of the illegal production operator, business place, legal representative or principal and the name, title and ID card number (part concealed) of the direct principal, the cause of the offense, administrative penalty decision, starting and finishing dates of the publication, and other information.
Article 12 The time limit of the production operator or responsible personnel listed in article 7 of the Regulations published in the drug safety “black list” column shall be consistent with the time limit of the measure taken to limit his/her behaviors. For circumstances without clear stipulation in law or administrative regulations, the publication time is generally two years. The time limit starts from the date when the administrative penalty decision is made.
When the publication time expires, the National or Provincial (regional, municipal) Food and Drug Administration shall delete their information from the drug safety “black list” column and transfer the information to the “drug safety ‘black list’ database”.
Article 13 The food and drug administration shall, when handing the administrative licensing matters related to drugs and medical devices, check according to the drug safety “black list” and shall not grant the license to the applicant with circumstances listed in Article 8 of the Regulations. The Food and Drug Administration shall focus on checking whether the production operator has any behavior against the Article 8 of the Regulations during daily supervision and inspection, and correct those behaviors once they are found.
Article 14 For production operators listed in the food safety “black list”, the food and drug administration shall record that in the supervision archives, take measures like increasing inspection and spot check frequencies and demanding them to report their quality management situation regularly, and implement key supervision to them. In addition to publishing the drug safety “black list”, the food and drug administration should also establish a production operator illegal behavior record system according to the requirements of the Regulations on Open Government Information and Special Provisions of the State Council on Strengthening the Supervision and Management of Safety of Food and Other Products, record and publish the circumstances of all illegal behaviors, and promote the construction of a social integrity system.
Article 15 The food and drug administration department should notify the drug safety “black list” to the departments at the same level, including the development and reform department, the financial department, taxation, health, environmental protection, industry and commerce, engineering and information and commerce for their reference during industry plan implementation, bidding and procurement, administrative examination and approval, financial credit and making other relevant decisions.
Article 16 Where a food and drug supervising officer violates the Regulations, abuses his or her authority, engages in malpractices for personal gains, and neglects his duty, the supervisory organ or the personnel department shall give sanctions to his/her person chiefly in charge, executive directly liable, and other direct responsible persons.
Article 17 Encourage social organizations or individuals to supervise the units and individuals listed in the drug safety “black list”, and they have the right to report to the food and drug administration if they find any illegal behaviors.
Article 18 The food and drug supervision administration of all provinces (autonomous regions, municipalities) may, in accordance with the Regulations, formulate the detailed implementation.
Article 19 The Regulations shall enter into force as of the date of promulgation.
Information Source: China National Food and Drug Administration