Food and Drug Administration publishes regulations on drug safety blacklist management

On August 14th, the State Food and Drug Administration issued the "Drug Safety "Black List" Management Regulations (Trial)" (hereinafter referred to as the "Regulations"), which imposes administrative penalties for serious violations of the laws, regulations and rules governing pharmaceuticals and medical devices. The relevant information of production and business operators and their responsible personnel will be announced through the government affairs website, subject to social supervision and implementation of key supervision. This regulation will come into effect on October 1, 2012.

Establishing a “black list” of drug safety is an active exploration of the State Food and Drug Administration to further strengthen the safety supervision and management of pharmaceuticals and medical devices, promote the establishment of a credit system, improve the industry's ban and withdrawal mechanisms, and urge production operators to fully perform Responsibility for quality and safety, strengthening the supervision of the whole society, and deterring illegal activities.

The "Regulations" stipulate that serious illegal producers and operators who have been subjected to administrative punishment in one of the following cases shall be included in the "black list" of drug safety:

First, production and sales of counterfeit medicines, inferior medicines were revoked drug certification documents, or were revoked, "Drug Production License", "Drug Business License" or "Medical Institution Preparation License";

The second is that the medical device product registration certificate has not been used to produce medical devices, or the production of medical devices that do not meet the national standards and industry standards is serious, or other production and sales do not meet the statutory requirements. The medical device has caused serious consequences. The medical device product registration certificate was revoked. , "Medical Device Manufacturing Enterprise License" and "Medical Device Operation Enterprise License";

The third is to hide relevant information and provide false materials in the process of applying for relevant administrative licenses;

Fourth, provide false proofs, samples of documentary materials, or take other fraudulent, bribery or other improper means to obtain relevant administrative licenses, approvals, or other qualifications;

Fifth, in the course of the investigation of administrative penalty cases, the site was forged or vandalized, the evidence was transferred, concealed, forged or destroyed, and the relevant circumstances and materials were refused or evaded supervision or inspection, and unauthorized seizure and seizure of articles were used;

Sixthly, it is criminally punished for illegal acts of drugs and medical devices. Seventh, other serious violations of statutory conditions require the production or sale of drugs or medical devices, resulting in major quality and safety incidents, or subjective intent, bad circumstances, and serious damage. Drugs, medical equipment illegal activities.

At the same time, those responsible for the production and sale of counterfeit medicines and the production and sales of inferior drugs, and who are not punished for drug production or business activities within 10 years, should also be included in the "black list" of drug safety.

The "Regulations" require food and drug regulatory departments at or above the provincial level to set up a "drug safety" blacklist 'column' in the prominent position on the home page of their government affairs website, which will be managed and updated by special personnel. The State Food and Drug Administration publishes the producers, managers, and responsible personnel involved in the major administrative punishment cases that they investigate in the “drug safety” blacklist column. The matters to be announced include the name, business address, legal representative or person in charge of the illegal producer and operator and the name, title, identity card number (hidden part number) of the person responsible for the liability as stipulated in the second paragraph of Article 7 of the present Provisions, violation of the law, The administrative penalty decision, announcement start date and other information. At the expiration of the publication deadline, the information in the "drug safety" blacklist "box" was transferred to the "drug safety" blacklist database for social inquiries.

The "Regulations" pointed out that when food and drug regulatory authorities handle administrative licenses for drugs and medical devices, they should review the information in the "drug safety" blacklist. For the illegal producers and operators announced in the “Public Drug Security Black List” column, the food and drug supervision authorities shall record the supervision files, and take measures such as increasing inspections and sampling frequency, and ordering regular reports on quality management and other measures to implement key supervision. Food and drug regulatory personnel who violate the provisions and abuse their power, engage in malpractice for personal gains, or neglect their duties shall be given disciplinary sanctions by the supervisory authority or the dismissal authority according to law for their principal responsible persons, directly responsible personnel in charge, and other persons directly responsible.

The State Food and Drug Administration encourages social organizations or individuals to supervise units and individuals listed on the 'black list' of drug safety. The food and drug regulatory authorities of all provinces (autonomous regions and municipalities) may formulate detailed rules for the implementation of the "black list" management rules for drug safety in light of local conditions. Article 1 To further strengthen safety supervision and management of medicines and medical devices, promote the establishment of a credit system, improve the industry's ban on entry and exit mechanisms, supervise producers and operators in fulfilling their overall responsibility for quality and safety, and strengthen the supervision of the entire society to deter illegal activities. These regulations are formulated in the Administrative Law, the Administrative Licensing Law, the Regulations on the Supervision and Administration of Medical Devices, the Regulations on the Disclosure of Government Information, and other relevant laws and administrative regulations.

Article 2 The food and drug supervision and administration department at or above the provincial level shall establish a “black list” of drug safety in accordance with the requirements of these regulations, and shall be directly responsible for the production and business operators who are subject to administrative penalties for serious violations of the laws, regulations, and regulations on drug and medical device management. The relevant information of the supervisors and other directly responsible personnel (hereinafter referred to as responsible personnel) is announced through the government affairs website and accepted by the public.

Article 3 The term "producer-operator" as used in these Regulations refers to an enterprise or other entity engaged in the development, production, operation and use of pharmaceuticals and medical devices within the territory of the People's Republic of China.

Article 4 The State Food and Drug Administration is responsible for the administration of the “black list” of drug safety throughout the country, and the food and drug supervision and administration departments of all provinces (autonomous regions and municipalities) are responsible for the “black list” management of drug safety within their administrative areas.

Article 5 The "black list" of drug safety shall be published in accordance with the principle of being open, objective, timely and fair.

Article 6 The food and drug supervision and administration department at or above the provincial level shall set up a "drug safety" blacklist 'column' on the prominent position of its government affairs website, and be managed and updated by special personnel.

The State Food and Drug Administration shall, in accordance with these Provisions, publish the producers, managers and responsible personnel involved in the major administrative punishment cases that they investigate in the "drug safety" black list.

The food and drug supervision and administration departments of all provinces (autonomous regions and municipalities) publish the “black list” drug safety “blacklist” on their government affairs website, announce the producers, managers, and personnel responsible for the “blacklist” of drug safety within their administrative regions, and report to the national food and drug Supervision Authority. The “Drug Safety 'Black List' column of the State Food and Drug Administration reprints the “black list” of drug safety promulgated by the food and drug regulatory authorities of all provinces (autonomous regions and municipalities).

Article 7 Seriously illegal production and business operators that meet the following conditions and are subject to administrative punishment shall be included in the "black list" of drug safety:

(1) Producing and selling counterfeit drugs or inferior drugs whose pharmaceutical approval documents have been revoked or whose Pharmaceutical Production Licenses, Pharmaceutical Trade Licenses or Pharmaceutical Institutional Permits have been revoked;

(2) Failure to obtain medical device product registration certificate for the production of medical devices, or serious production of medical devices that do not comply with national standards or industry standards, or other production or sales that do not meet the statutory requirements. Medical devices have serious consequences and are revoked. Certificate, "Medical Device Manufacturing Enterprise License", "Medical Device Operation Enterprise License";

(3) concealing relevant circumstances and providing false materials in the process of applying for relevant administrative licenses;

(4) Providing false proofs, samples of documentary materials, or taking other fraudulent, bribery, and other improper means to obtain relevant administrative licenses, approvals, or other qualifications;

(5) In the process of investigating administrative penalties, falsifying or intentionally destroying the scene, transferring, concealing, forging or destroying relevant evidence and materials, and refusing to evade supervision or inspection or refusing to provide relevant information and materials, and unauthorized use of the sealed up and seized items;

(6) Having been subjected to criminal penalties for illegal acts of drugs or medical devices;

(7) Other violations of statutory requirements, production and sales of pharmaceuticals or medical devices, resulting in major quality and safety incidents, or illegal acts of drugs or medical devices that are subjectively intentional, have serious circumstances, and are seriously endangered.

The responsible person who produces and sells counterfeit medicines, produces and sells inferior medicines and has serious penalties that cannot be engaged in drug production or business activities within 10 years shall also be included in the “black list” of drug safety.

Article 8 When the “blacklist” of drug safety is announced, the production and business operators who have one of the following circumstances shall publish the time limit for prohibiting them from engaging in related activities in accordance with the administrative penalty decision:

(1) In the case of the production and business operators who have the circumstances of paragraph (3) of the first paragraph of Article 7 of these Regulations, the food and drug supervision and administration department shall not accept or impose administrative licenses on the applications for administrative licenses, and the producers and operators shall be within one year. The administrative license may not be applied again. However, if an administrative punishment decision is made in accordance with Article 70 of the Regulations for the Implementation of the Drug Administration Law, the application will not be accepted within three years;

(2) In the case of the production and business operators of the first paragraph (4) of Article 7 of these Regulations, the food and drug supervision and administration department shall not only revoke or revoke its license, approval certificate, or other qualifications, but also the production and business operators shall be within three years. The administrative license may not be applied again. However, if an administrative penalty decision is made in accordance with Article 83 of the Drug Administration Law and Article 75 of the Regulations on the Administration of Narcotic Drugs and Psychotropic Substances, the application will not be accepted within five years.

Responsible personnel who meet the circumstances of the second paragraph of Article 7 of these Regulations shall not employ pharmaceutical production and business operators to engage them in pharmaceutical production or business activities for ten years.

Article 9 The State Food and Drug Administration or the food and drug supervision and administration department of the province (autonomous region or municipality) shall be within fifteen working days after the entry into force of the administrative penalty decision for the inclusion of a "black list" of drug safety in accordance with Article 7 of these Regulations. , announced on its government affairs website. The State Food and Drug Administration shall, within five working days after receiving the "black list" of drug safety reported by the provincial (district, city) food and drug supervision and administration department, reprint it on its government affairs website.

Article 10 The items to be announced include the name, business address, legal representative or person in charge of the illegal producer and trader, and the name, title, identity card number (hidden part number) of the responsible person as prescribed in the second paragraph of Article 7 of these regulations. The violation of the law, the decision of administrative punishment, and the announcement of the date of initiation and termination.

Article 11 The period for promulgating the illegal production and business operators and responsible persons in the “drug safety” blacklist “column” shall be consistent with the time limit for the behavioral restriction measures that they are adopted. Where laws or administrative regulations do not provide for behavioral restrictions, the period for publication is two years. The period is calculated from the date of the decision to make the administrative penalty.

At the expiration of the publication deadline, the information in the "drug safety" blacklist "box" was transferred to the "drug safety" blacklist database for social inquiries.

Article 12 The food and drug supervision and administration department shall review the information in the "Pharmaceutical Security's blacklist" column when handling the relevant administrative licensing items for drugs and medical devices. The applicant shall have the conditions listed in Article 8 of this Regulation for the applicant. Not allowed.

The food and drug supervision and administration departments found that they have violated Article 8 of these Regulations in their supervision and inspection, and shall promptly correct them in accordance with the law.

Article 13 For illegal producers and operators disclosed in the "drug safety" black list, the food and drug supervision and administration department shall enter the supervision files, and take measures such as increasing inspections and sampling frequency, and ordering regular reports on quality management. Implement key supervision.

Article 14 In addition to promulgating the “black list” of drug safety, the food and drug supervision and administration department shall also establish the production and business operators in accordance with the requirements of the “Regulations on the Disclosure of Government Information” and the “Special Provisions of the State Council on Strengthening the Safety Supervision and Administration of Food Products”. The illegal record system records and publishes all illegal activities and promotes the establishment of a social credit system.

Article 15 Where food and drug regulatory personnel violate these regulations, abuse their power, engage in malpractices for personal gains, or neglect their duties, the supervisory authority or the dismissal authority shall, in accordance with the law, impose sanctions on its principal responsible person, the directly responsible person in charge, and other persons directly responsible.

Article 16 Encourage social organizations or individuals to supervise units and individuals that have been included in the "blacklist" of drug safety. If any violation is found, they have the right to report it to the food and drug supervision and administration department.

Article 17 The food and drug supervision and administration departments of all provinces (autonomous regions and municipalities) may, in accordance with these Provisions, formulate detailed rules for the implementation of the “blacklist” management rules for drug safety in light of local conditions.

Article 18 These regulations shall come into force on October 1, 2012.