Jiangsu Province Solicits Opinions and Suggestions on Drug Safety Credit Management Measures

Medical Network News, August 31, August 25, Jiangsu Provincial Drug Administration issued an announcement on the "Jiangsu Province Drug Safety Credit Management Measures (Draft for Solicitation of Comments)" for public comments and suggestions
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The original text is as follows:Announcement on the Public Solicitation of Proposals for the "Administrative Measures for Drug Safety Credit of Jiangsu Province (Draft for Comment)"is to establish and improve the drug safety credit system in our province, build a new regulatory mechanism for drug safety, strengthen the integrity of drug safety responsible entities, and promote With the high-quality development of the pharmaceutical industry in our province, in accordance with the spirit of relevant laws, regulations and documents concerning drug supervision and credit management, combined with the reality of drug supervision in our province, the Provincial Drug Administration drafted the "Measures for the Administration of Drug Safety and Credit in Jiangsu Province" (draft for comments) , We are now openly soliciting opinions from the public.
If you have comments and suggestions, relevant units and the public can give feedback to our bureau by letter or e-mail before September 28, 2021
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Mailing address: Inspection Division of Jiangsu Provincial Drug Administration, No.
5 Gulou Street, Gulou District, Nanjing City, Post Code: 210008.
E-mail: geah@da.
js.
gov.
cn
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In the letter and e-mail address, please indicate the words "Jiangsu Province Pharmaceutical Safety Credit Management Measures (Draft for Solicitation of Comments)"
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Drug Administration inspection of the province August 25, 2021Appendix:   　　Drug Safety, Jiangsu Province, credit management approach (draft)   　　Chapter I General Provisions   　　Article 1 In order to establish and improve the province drugs (including drugs, medical devices, cosmetics , under Same) Safety credit system, build a new drug safety supervision mechanism, strengthen the integrity of drugThe high-quality development of the industry is based on the "Drug Administration Law", "Vaccine Administration Law", " Medical Device Supervision and Administration Regulations", "Cosmetics Supervision and Administration Regulations", "Jiangsu Provincial Social Credit Regulations", "Market Supervision and Administration Measures for the Management of Lists of Serious Violations and Untrustworthiness", and "Market Supervision" These Measures are formulated in accordance with the spirit of laws, regulations and related documents such as the Regulations on the Publicity of Information on Administrative Punishments, the Measures for the Administration of Credit Repair in Market Supervision and Administration, and the spirit of relevant documents
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Article 2 These Measures apply to the construction of the pharmaceutical safety credit system and the management of pharmaceutical safety credit in our province
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Drug safety credit management includes drug safety credit information management, credit status determination, credit restoration, and credit incentives and constraints
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Where laws and administrative regulations have new regulations on drug safety credit management, those regulations shall be followed
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Article 3 The drug safety credit referred to in these Measures refers to the state in which the subject of drug safety credit complies with the legal obligations of drug safety and fulfills the agreed obligations in social and economic activities
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The subjects of drug safety credit include citizens, legal persons or other organizations (hereinafter referred to as drug producers and operators) engaged in the research, production, operation and use of drugs in our province
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Article 4 The drug safety credit information mentioned in these Measures refers to the objective data and materials that can be used to identify, analyze, and judge the credit status of drug manufacturers and operators, including drug safety public credit information and drug safety market credit information
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Pharmaceutical safety public credit information refers to the credit information generated and obtained by the pharmaceutical supervision and administration department in the process of performing its duties and providing public services in accordance with the law, including basic information, untrustworthy information, and other information
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Drug safety market credit information refers to the market credit information collection units, such as credit service agencies, pharmaceutical industry associations and chambers of commerce, and other enterprises and institutions that implement credit management on transaction service objects , which are generated or acquired during production and operation or industry self-regulatory management activities.
Credit information
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Article 5 The establishment of a drug safety credit system shall follow the principles of government promotion, social joint construction, laws and regulations, protection of rights and interests, fairness and openness, and the combination of rewards and punishments
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The construction of a drug safety credit system should focus on the role of industry associations, chambers of commerce and other social organizations, and encourage and guide social forces to participate in drug safety credit management, service and supervision
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Article 6 The Provincial Drug Administration (hereinafter referred to as the Provincial Bureau) is in charge of the construction of the province's drug safety credit system and drug safety credit management.
The Provincial Bureau Inspection Division is responsible for the management of the list of severely illegal untrustworthy and credit restoration work; drug supervision and management at the county level and above The department is responsible for the establishment of the drug safety credit system and the management of drug safety credit within the administrative region
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The higher-level drug supervision and management department has the responsibility of supervising and guiding the construction of the drug safety credit system and the drug safety credit management of the lower-level drug supervision and management department
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Article 7 Pharmaceutical manufacturers and operators shall enhance the awareness of the rule of law and the spirit of contract, abide by laws, regulations, standards and industry regulations, and perform in good faith and compete fairly
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Encourage drug manufacturers and operators to establish and improve internal credit management systems, improve credit management capabilities, prevent drug safety credit risks, and participate in activities such as creating credit management demonstrations
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Article 8: The provincial bureau's drug safety credit system construction should give full play to its exemplary and leading role, and actively take the lead in promoting cooperation in the construction of a credit system in the field of drug safety in the Yangtze River Delta region
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  　　Chapter II credit information management   　　Article IX drug safety, public credit information may include, but are not limited to basic information, regulatory information, illegal information, drug manufacturers and distributors who report information, annual credit conditions and other circumstances identified
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Article 10 Basic information may include, but is not limited to, enterprise name, social credit code, registered capital, business scope, registered address, division and merger, etc.
; information on obtaining, changing, and renewing drug-related licenses, obtaining, changing, and renewing drug-related certifications.
Information on continuation, division and merger, record vouchers for drug development, production, and operation and their changes; the legal representative of the drug manufacturer, the person in charge of the company, the person in charge of research and production, the person in charge of quality management (or the quality authorized person) And other personnel’s information and its change filing information
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Article 11 Product information may include, but is not limited to, the name of the drug production and operation product, the product registration certificate number, the approval document number, the implementation standard, the production product and the product registration certificate supplementary application approval or case preparation, re-registration information, entrusted or entrusted production information, commissioned the inspection information, accept foreign commissioned production information, product registration number and product technology requirements
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Article XII regulatory kinds of information including daily supervision and inspection results, quality sampling, record of bad behavior and complaints and reports and so on
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Article 13 Information on violations of laws and regulations includes administrative penalties, criminal penalties and other information handled by drug regulatory authorities for drug manufacturers and operators who violate drug management laws, regulations and rules
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The other information handled by the drug regulatory authority as prescribed in the preceding paragraph shall include but is not limited to the following circumstances: (1) It constitutes a violation of laws and regulations but is not granted or exempted from administrative penalties in accordance with the law; (2) Due to quality problems or other hidden safety hazards, Where the drug supervision and administration department takes measures such as warnings, interviews, rectification within a time limit, ordering recalls, and suspension of production, sales, use, and imports; , Destroying relevant evidence and materials, voluntarily use seals to seize articles without authorization; (4) When a drug safety emergency occurs, causing impact or harm; (5) Refusal to implement the effective drug administrative penalty decision; (6) Laws, regulations and rules Other information required
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Article 14 Encourage the collection and sharing of drug safety market credit information and other credit information
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The credit information of the drug safety market may include, but is not limited to, the following: (1) Play a typical exemplary role in major drug innovations, obtain national or provincial commendations and rewards, or provide information on drug safety, effectiveness, accessibility, and quality.
Those who have been commended and rewarded by the people’s government at or above the districted city level in terms of prosecution; (2) Reporting others’ drug violations has been verified to be true and performing meritorious service; (3) Actively participating in the recovery of expired drugs, popular science law publicity, social assistance, and social donations Such public welfare activities in the pharmaceutical field have been commended and rewarded by the people's government at or above the city level with districts
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Article 15 The drug regulatory authority at or above the county level shall, in accordance with the principles of objectivity, comprehensive truth, fairness and impartiality, and the principles of "who generates and enters" in accordance with the law, carry out the work of collecting the credit information of drug manufacturers and operators, and establish the credit files of drug manufacturers and operators.
And keep it updated dynamically
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Article 16 The drug supervision and administration department shall collect and enter various types of credit information in accordance with regulations within five working days from the date when the administrative license, supervision and inspection, and administrative punishment are completed
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In principle, the preservation period of credit information files of pharmaceutical manufacturers and operators shall not be less than five years
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After discontinuing the production and operation of drugs, after the drug license or record certificate is handed in for cancellation, the retention period of the credit information files shall not be less than two years
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If an administrative law enforcement act is cancelled or confirmed to be illegal through legal procedures, the drug regulatory authority responsible for entry shall cancel or modify the credit information associated with the administrative act within five working days from the date of receiving the cancellation decision
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Article 17 The information listed in Article 14 of these Measures shall be declared by the drug manufacturer and business operator, and relevant certification materials shall be submitted
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The drug supervision and administration department at or above the county level in charge of daily supervision shall conduct review and confirmation within five working days and enter its credit file
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Article 18 The recording period of the basic information of drug manufacturers and operators is from the date of approval or filing to the date of cancellation or cancellation of the permit; the recording period of credit information is from January 1 to December 31 of each year
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After the expiration of the above period, the above information together with credit status, etc.
will be automatically transferred to historical credit information
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  　　Chapter III credit status finds that   　　Article XIX credit status finds follow the objective, fair and impartial, the precautionary principle, combined with credit scoring and illegal activities of the severity of the comprehensive assessment
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Article 20: In principle, the credit ratings of pharmaceutical producers and operators are divided into four levels: trustworthiness, basic trustworthiness, general dishonesty, and serious dishonesty
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Article 21.
The identification of trustworthiness and basic trustworthiness is divided into the main points by credit score, and the supervision of production, operation, and use can be combined with actual conditions to formulate corresponding classification and identification standards
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Article 22 The determination of general dishonesty and serious dishonesty shall be based on a legally effective document as the main basis
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Article 23 During the assessment year, if a drug manufacturer violates laws or administrative regulations, is severe in nature, has serious circumstances, and has greater social harm, and is subject to severe administrative penalties by the drug regulatory authority, and one of the following circumstances is involved, it shall be directly determined Grades of serious dishonesty: (1) Production and sale of counterfeit or inferior drugs, illegal production and sale of drugs that have special regulatory requirements in the country, production, import, and sales of drugs that have not obtained drug approval documents; (2) Production and sales of unregistered drugs The second and third categories of medical devices; (3) The production and sale of cosmetics that have illegally added substances that may harm human health; (4) Submitting false materials or adopting other means to conceal important facts, obtaining administrative licenses, or altering, reselling, renting, or selling licenses Credentials; (5) Refusing, obstructing, or interfering with the supervision and inspection and accident investigation carried out by the drug supervision and administration department in accordance with the law; (6) Other violations of the laws and administrative regulations on drugs, medical devices, cosmetics, and serious harm to the health and life safety of the people Behavior
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  　　The heavier penalties stipulated in the first paragraph of this article include:   　　(1) In accordance with the administrative penalty criteria, fines shall be imposed in accordance with the principle of heavier punishment; (2) The qualification level shall be lowered and the license shall be revoked; (3) Production and business activities shall be restricted, production and business shall be suspended, closed, and employment restricted; (4) Laws , Administrative regulations and other heavy administrative penalties stipulated by departmental rules
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Article 24: After the drug regulatory authority makes administrative penalties, administrative rulings and other administrative decisions, if a drug manufacturer has the ability to perform but refuses to perform, evades execution, etc.
, which seriously affects the credibility of the drug regulatory authority, it shall be deemed as severely untrustworthy.

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Article 25 During the year of certification, those who have one of the following circumstances and fail to meet the criteria for determining the level of serious dishonesty shall be considered as general dishonesty: (2) Laws, regulations, or relevant national documents can be identified as a general level of dishonesty
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Article 26 If a drug manufacturer has sufficient evidence to prove that there is no subjective and deliberate violation of laws and regulations, it may not be considered as a serious dishonesty level
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Article 27 The year for determining the credit status shall be one year retroactively starting from December 31 of the current year
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Those who obtain the production and operation license or record after June 30 (excluding June 30) of the certification year, or have been out of business for more than half a year, will not participate in the credit status certification in the current year, and the credit information during this period will be included in the next certification year
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The validity period of the credit rating recognized by the drug regulatory authority is one year.
During the period, if a drug manufacturer meets the provisions of Article 23 and Article 24 of these Measures, its credit status shall be immediately lowered to a severely dishonest rating
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  　　Chapter Four serious violations of dishonesty List Management   　　Article 28 The credit situation is serious dishonesty level of drug production operators, included in the list of serious violations of dishonest management
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When the drug supervision and administration department makes a decision to include the drug manufacturer and business operator on the list of serious violations of untrustworthiness, the listing decision shall specify the reason, basis, reminder of disciplinary measures, removal conditions and procedures, and relief measures
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Before making a listing decision, the drug regulatory authority shall inform the parties of the reasons and basis of the decision and the rights enjoyed by the parties in accordance with the law; if the parties raise objections, they shall be verified and feedback within the prescribed time limit
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Article 29: Where legal persons and other unincorporated organizations are included in the list of serious violations of untrustworthiness, the drug regulatory authority shall check the personal credit records of the responsible legal representative, main responsible person, actual controller, and other directly responsible persons.
Synchronous labeling in
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Article 30: If the administrative punishment on which the listing on the list of serious violations of untrustworthiness is based is revoked or confirmed as illegal or invalid, the drug regulatory authority shall revoke the decision to list drug manufacturers and operators, and stop publicizing relevant information within three working days.
, And lift related management measures
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Article 31 If a drug manufacturer and business operator is included in the list of severely illegal and untrustworthy for three years, the drug supervision and administration department included in the list of severely illegal and untrustworthy shall be removed, stop publishing relevant information, and remove relevant management measures
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If measures such as restricting production and business activities and restricting employment in accordance with laws and regulations have been implemented for more than three years, they shall be implemented in accordance with the actual restriction period
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Article 32 If the drug regulatory authority at the county level or the city divided into districts makes a decision to be included in the list of serious violations of law and trust, it shall report to the drug regulatory authority at the next higher level for approval
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  　　Chapter five Credit Repair   　　principle according to Credit Repair "who finds who fix" Article 33, classification implementation
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Drug supervision and administration departments at or above the county level shall establish a credit repair mechanism for drug manufacturers and operators, and encourage untrustworthy persons to repair their credit
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Article 34 The term "credit restoration" as mentioned in these Measures means that the drug regulatory authority removes qualified drug manufacturers and operators from the list of serious violations and untrustworthiness in advance in accordance with the prescribed procedures, and stops passing the official website of the drug regulatory authority and national enterprise credit in advance.
The information publicity system publicizes relevant information such as administrative penalties, lifts relevant management measures in accordance with the law, and shares credit restoration information with relevant departments in a timely manner in accordance with regulations
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Article 35 Pharmaceutical manufacturers and operators shall take the initiative to correct untrustworthy behaviors, actively perform statutory responsibilities and obligations, complete rectification, eliminate adverse social effects, take the initiative to improve credit status, and apply for credit restoration in accordance with prescribed conditions and procedures
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Article 36 Pharmaceutical producers and operators who are ordered to suspend production and business, restrict production and business activities, restrict their business, lower their qualification levels, revoke licenses, and other relatively serious administrative penalties prescribed by the drug supervision and administration department, shall not be granted credit restoration
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Article 37 Except for the circumstances stipulated in Article 36 of these Measures, or only receiving warnings, notifications of criticism, and relatively low fines, other administrative penalty information disclosure period has expired for one year, and the following conditions are met, you can apply for credit Repair: (1) Has consciously performed the obligations stipulated in the administrative penalty decision; (2) Has taken the initiative to eliminate the harmful consequences and adverse effects; (3) Has not been subject to administrative penalties by the drug regulatory authority again for the same type of illegal acts; (4) Failed In the list of serious violations of untrustworthiness
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Article 38: Pharmaceutical producers and traders who have been included in the list of severely illegal and untrustworthy for one year and meet the following conditions may apply for credit restoration and be removed from the list of severely illegal and untrustworthy: (1) Have consciously performed the obligations stipulated in the administrative penalty decision (2) Has taken the initiative to eliminate the harmful consequences and adverse effects; (3) Has not received heavy administrative penalties from the drug regulatory authority again
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According to the provisions of laws and administrative regulations, if the time limit for implementing corresponding management measures has not expired, it is not allowed to apply for early removal
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Article 39 To apply for credit restoration, the following materials shall be submitted: (1) Credit restoration application form (Annex 1); (2) Credit commitment letter (Annex 2); (3) Relevant materials for fulfilling statutory obligations and correcting illegal acts (4) Other materials required by the drug regulatory authority
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Applicants can go to the drug regulatory authority or submit an application to the drug regulatory authority through a designated information system
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The drug supervision and administration department shall make a decision on whether to accept the application within two working days from the date of receipt of the application
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If the application materials are complete and conform to the legal form, it shall be accepted and the applicant shall be notified; if it is not accepted, the applicant shall be notified and the reasons shall be explained
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Article 40 The drug regulatory authority shall make a credit restoration decision (Annex 3) within 15 working days from the date of acceptance
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Those who are permitted to stop publicizing information on administrative punishments or remove them from the list of severely illegal and untrustworthy shall stop publicizing relevant information or remove them from the list of severely illegal and untrustworthy within three working days from the date of the decision, and remove relevant management measures in accordance with the law
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If the publicity of administrative penalty information is not stopped in advance or removed from the list of serious violations of untrustworthiness, the applicant shall be notified and the reasons shall be explained
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In accordance with laws and administrative regulations, the time limit for implementing corresponding management measures has not yet expired except
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Article 41 After the credit of the pharmaceutical manufacturer and business operator is restored, the untrustworthy behavior involved will no longer be used as the basis for determining the credit status
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Article 42 The drug regulatory authority shall, within three working days after removing the list of serious violations of untrustworthiness, or stopping the publication of administrative punishment and other related information, push the credit restoration decision to the social credit comprehensive management department of the people's government at the same level
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Article 43: If the applicant deliberately concealed the true situation or resorted to falsification, and the circumstances are serious, the drug regulatory authority shall revoke the decision to approve credit restoration and restore the previous status
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Recalculation of the publicity period for information on administrative penalties of the drug supervision and administration department and the list of serious violations of untrustworthiness
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Article 44: If the drug supervision and administration department at the county level or the city divided into districts makes a decision to remove the list of serious violations and untrustworthiness in advance, it shall report to the drug supervision and administration department at the next higher level for approval
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  　　Chapter VI credit incentive and restraint   　　Article 45 pharmaceutical producers and operators of trustworthiness level, adhere to self-based, supplemented by the principle of regulation, credit rating within the validity period, you can enjoy the following incentives: (a) the standards are not lowered , Under the circumstance that the procedures are not reduced, the administrative approval, qualification review, filing and other procedures shall be given priority in accordance with laws and regulations, and a “green channel” may be opened to speed up the approval process; Exempt daily supervision and inspection and follow-up inspection, and reduce the number of supervision and random inspections; (3) Recommend participating in key project declaration, bidding, enjoying government subsidies and awards from the government, relevant departments, and industry organizations; (4) Using credit information management system The reminder function in, supervise their self-examination and self-correction, and consider exemption or mitigation of punishment for minor problems that can be corrected in time
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Article 46 For drug producers and operators with basic trustworthiness levels, adhere to the principle of combining self-discipline and supervision, and take the following measures during the validity period of the credit level: (1) Maintain the intensity of daily supervision and inspection; (2) Normally conduct product supervision and random inspections (3) Follow-up inspection can be carried out on its rectification and improvement; (4) The drug supervision and administration department can give credit reminders to it
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Article 47: For drug producers and operators with general untrustworthy levels, adhere to the principle of key supervision and take the following measures during the validity period of the credit level: (1) List them as key supervision and inspection objects and increase supervision and inspection; ) Appropriately increase the batch and frequency of product supervision and sampling inspection; (3) Regular or irregular responsibility interviews or surprise inspections; (4) Regular or irregular submission of safety self-inspection reports or third-party evaluation reports may be ordered; (5) The notification and commitment system is not applicable; (6) Notify the relevant departments of its credit rating and the investigation and punishment of illegal acts
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Article 48: For drug manufacturers and operators with severely untrustworthy levels, adhere to the main supervision principles, and take the following measures during the validity period of the credit rating: (1) List them as the main subject of supervision and inspection, and increase the frequency of daily supervision and inspection and unannounced inspections (2) Increase the batch and frequency of random inspections for supervision; (3) For those who violate drug-related laws and regulations again during the assessment year, the upper limit of penalties shall be applied; (4) Include them in the management of the province's drug safety serious violations and untrustworthy list, Public disclosure in accordance with relevant national and provincial regulations; (5) Responsible persons shall be restricted from engaging in drug-related production and business activities within a certain period in accordance with relevant provisions of laws and regulations; (6) Ordering them to regularly submit safety self-inspection reports or third parties Evaluation report; (7) Notifying relevant departments of their serious violations of laws and untrustworthiness, and implementing joint punishments on them
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  　　Chapter VII Supervision and Administration   　　Article 49 superior drug regulatory departments shall supervise the work to identify the credit status of subordinate supervision of medicines sector organizations, we found that the results found inappropriate and should be corrected promptly
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Article 50 Anyone who violates credit management laws, regulations and rules shall be investigated for legal responsibility in accordance with the law
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  　　Chapter VIII Supplementary Provisions   　　Article 51 administrative licensing, administrative penalties and other public publicity related to credit information, in accordance with relevant provisions of the state and the province
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Article 52 Drug regulatory authorities at all levels may refer to these Measures and Annexes, and combine regulatory powers to formulate drug safety credit management systems and implementation rules
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Article 53 The terms "above" and "below" in these Measures include the number or level
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Article 54 The inspection department of the provincial bureau is responsible for the interpretation of these measures
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Article 55 These Measures shall come into force on XX month XX day of XXXX year
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