Medical Network November 5th On November 1, the revised draft of the Drug Administration Law was officially announced.
 
On November 1, the draft amendment to the Drug Administration Law was published in the China National People's Congress. It began to publicly solicit opinions from all walks of life. The deadline for soliciting opinions is December 1, 2018.
 
Drug Administration Law Amendment Draft
 
The announcement shows that the draft has mastered the following points in its overall thinking:
 
The first is to implement the "four most stringent" requirements, adhere to the rules and regulations, eliminate the abuses, strengthen the supervision of the whole process, and resolutely hold the public security bottom line.
 
The second is to revisit the outstanding problems exposed by the problem vaccine case, implement the drug listing permit holder system and promote the reform of the examination and approval system, and respond to social concerns in a timely manner; and make other changes to other less urgent needs when the next revision is comprehensive.
 
The third is to implement the "Innovation Opinions", reform and improve the drug review and approval system, encourage drug innovation, and strengthen post-event supervision.
 
finishing seven points
 
1. Vaccine and other listed license holders may not entrust production
 
One article is added as Article 5: “The State implements the system of holders of drug listing licenses. The holders of drug marketing licenses shall ensure that drugs are safe and effective, and bear responsibility for the whole process of drug development, production, operation and use.
 
“The legal representative or principal responsible person of the drug marketing license holder is fully responsible for the quality of the drug.
 
The specific management measures for holders of drug marketing licenses shall be formulated by the drug regulatory authority under the State Council.
 
Add one as Article 33: "If the holder of the drug marketing license produces the drug by himself, he shall obtain the "Pharmaceutical Production License" in accordance with the provisions of this Law; if the production is entrusted, the drug manufacturer that meets the requirements shall be selected. Vaccine, Blood products, narcotic drugs, psychotropic drugs, and medical toxic drugs shall not be entrusted to production; however, except for the case that the drug regulatory department under the State Council stipulates that production may be entrusted.
 
Article 33 is changed to Article 38, and one paragraph is added as the second paragraph: “The holder of the drug marketing license shall carry out the safety and effectiveness of the listed drugs in accordance with the requirements of the drug regulatory authority under the State Council. Evaluation."
 
2, drugs can be traced back to the law
 
One article is added as Article 35: “The holders of drug-listing licenses, production enterprises, operating enterprises, and medical institutions shall establish and implement strict drug quality and safety traceability systems to ensure traceability of drugs.
 
3. The state implements a compulsory insurance system for vaccine liability
 
"In the process of development, production, circulation and vaccination of vaccines, informational means should be used to collect and retain traceability information."
 
Add one as Article 36: “The State implements a compulsory insurance system for vaccine liability. The holder of the marketing license for the vaccine shall be insured in accordance with relevant state regulations.”
 
"The drug regulatory authority shall implement key supervision and inspection of biological products such as vaccines.
 
Add one, as Article 100: "If one of the following acts is imposed, it shall be severely punished within the penalty range prescribed by this Law: "(1) Narcotic drugs, psychotropic drugs, medical toxic drugs, radioactive drugs are pretending to be other drugs, Or pretending to be a drug with other drugs; "(2) Producing and selling counterfeit or inferior drugs that are mainly used by pregnant women, infants and children; "(3) Biological products such as vaccines produced and sold are false "(4) Producing and selling counterfeit drugs and inferior drugs, causing the consequences of personal injury; "(5) Producing and selling counterfeit drugs and inferior drugs, and repeating them after being disposed of; "(6) Refusal, Evade supervision and inspection, or forge, destroy or conceal relevant evidence materials, or use automatic seizure or seizure of articles."
 
4, production and marketing of counterfeit drugs, heavy penalties
 
Article 73 shall be changed to Article 84 and amended to read as follows: "If the production or sale of counterfeit drugs is carried out, the illegally produced and sold drugs and illegal gains shall be confiscated, the production shall be suspended, the business shall be suspended, and the documents for the approval of the drugs shall be revoked. And impose a fine of two times or more and ten times less than the illegal production and sales of the drug value; if the circumstances are serious, and impose a fine of 10 times or more and 30 times less than the illegal production and sales of the drug, the drug production license shall be revoked. , "Drug Business License" or "Medical Agency Preparation License"; if it constitutes a crime, criminal responsibility shall be investigated according to law."
 
Article 74 shall be changed to Article 85 and amended to read as follows: "If the production or sale of inferior drugs is made, the illegally produced and sold drugs and illegal proceeds shall be confiscated, and the value of illegally produced and sold drugs shall be more than doubled to five times. The following fines; if the circumstances are serious, and impose a fine of not more than five times and fifteen times the value of illegal production and sales of drugs, order to suspend production, suspend business for rectification until the drug approval certificate is revoked, the drug production license is revoked, and the drug is revoked. Business License or Medical Device Preparation License; if a crime is constituted, criminal responsibility shall be investigated according to law."
 
Article 75 shall be changed to Article 86, and the first paragraph shall be amended as: “The enterprise or other unit engaged in the production and sale of counterfeit drugs and the production or sale of inferior drugs, and its legal representative or principal responsible person The directly responsible person in charge and other directly responsible personnel shall confiscate the income earned from the unit during the period of the illegal act and the fine of 30% or more of the income of the office, and shall not engage in the production or business activities of the drug for life. ”
 
Article 76 shall be changed to Article 87 and amended to read: "If you know or should know that it is a counterfeit and inferior drug and provide convenient conditions for transportation, storage, warehousing, etc., all income from transportation, custody and warehousing shall be confiscated, and A fine of more than one time but not more than five times the illegal income; if the circumstances are serious, a fine of not less than five times and fifteen times the illegal income shall be imposed; if a crime is constituted, criminal responsibility shall be investigated according to law."
 
5. Drug purchase and sales rebate fines, suspension of certificates, and investigation of criminal responsibility
 
Article 89 shall be changed to Article 104, and shall be amended as: "The holders of drugs, production enterprises, operating enterprises, and medical institutions secretly giving, receiving or receiving rebates or other interests in the purchase and sale of drugs, drugs If the holder of the listing license, the manufacturer, the operating enterprise or its agent gives the person in charge of the medical institution using the drug, the drug purchaser, the physician, etc., the property or other interests, the market supervision and administration department shall charge 10,000 yuan. If the above-mentioned fine of less than 200,000 yuan is illegal or illegal, if the circumstances are serious, the market supervision and administration department shall revoke the business license of the drug listing license holder, the pharmaceutical production enterprise, and the pharmaceutical business enterprise, and notify the drug supervision and management. In the department, the drug regulatory authority shall revoke the drug approval certificate and revoke its Pharmaceutical Production License and Drug Business License; if it constitutes a crime, it shall be investigated for criminal responsibility according to law.
 
6. The drug regulatory authorities must be disciplined for these actions.
 
Add one as Article 144: "In case of violation of the provisions of this Law, if the drug supervision and administration department has one of the following acts, the directly responsible person in charge and other directly responsible personnel shall be given a record or a greater punishment; If it is serious, it shall be given a relegation or dismissal; if the circumstances are serious, the dismissal shall be given:
 
"(1) concealing, falsely reporting, or delaying the reporting of drug safety accidents; "(2) failing to investigate and deal with the discovered drug safety violations in a timely manner; "(3) failing to perform drug supervision and management duties, causing serious adverse effects or major losses. ”
 
7. Drug safety information cannot be disclosed without authorization
 
Add one as Article 76: “The State implements a unified system for the publication of drug safety information. The overall state of drug safety, drug safety risk warning information, major drug safety incidents and their investigation and processing information, and other information that the State Council determines to be uniformly announced. It shall be uniformly announced by the drug regulatory department of the State Council. The impact of drug safety risk warning information and major drug safety accidents and their investigation and processing information is limited to specific regions, and may also be announced by the drug regulatory authorities of the people's governments of relevant provinces, autonomous regions and municipalities directly under the Central Government. Authorization may not post the above information.
 
"The publication of drug safety information should be accurate and timely, and make necessary explanations to avoid misleading.
 
"No unit or individual may fabricate or distribute false drug safety information."
Attachment: Drug Administration Law of the People's Republic of China (Revised Draft)
 
First, add one, as Article 5: “The State implements the system of holders of drug listing licenses. The holders of drug marketing licenses shall ensure that drugs are safe and effective, and bear responsibility for the whole process of drug development, production, operation and use.
 
"In the development, production, operation and use of pharmaceuticals, we shall abide by laws, regulations, standards and norms to ensure that the data in the whole process is true, accurate, complete and traceable."
 
2. Article 5 shall be changed to Article 6 and the second and third paragraphs shall be revised as follows: “The department responsible for drug supervision and administration of the local people's government at or above the county level shall undertake the supervision and administration of drugs within its administrative region. The relevant departments of the People's Government are responsible for the supervision and administration of drugs in their respective areas of responsibility.
 
"The drug regulatory department of the State Council shall cooperate with the relevant departments of the State Council to implement the development plan and industrial policy of the pharmaceutical industry formulated by the State."
 
3. Add one article as Article 7: “The local people's government at or above the county level is responsible for the drug supervision and administration work within its administrative region, unified leadership, organization of drug supervision and management work within its administrative region, and response to drug safety emergencies, Establish and improve the drug supervision and management work mechanism and information sharing mechanism, include drug safety work in the national economic and social development plan at the same level, incorporate drug safety work funds into the government budget at the same level, strengthen drug supervision and management capacity building, and provide drug safety work. Guarantee."
 
4. Article 8 is changed to Article 10, and the fourth item is amended to read: “The rules and regulations that guarantee the quality of drugs and meet the requirements of the “Good Manufacturing Practices for Pharmaceutical Production” formulated by the drug regulatory authority under the State Council in accordance with this Law”.
 
Article 9 is changed to Article 11 and revised as follows: “To engage in pharmaceutical production activities, it must comply with the “Good Manufacturing Practices for Pharmaceutical Production”, establish and improve the production quality management system, and ensure that the entire process of pharmaceutical production continues to meet statutory requirements.
 
“The legal representative or principal responsible person of the pharmaceutical production enterprise is fully responsible for the pharmaceutical production activities of the enterprise.”
 
6. Article 10 shall be changed to Article 12, Article 52 shall be changed to Article 57, and the “pharmaceutical production enterprise” shall be deleted.
 
Article 54 is changed to Article 59, Article 58 is changed to Article 63, Article 92 is changed to Article 107, and the "production enterprise" is changed to " Listed license holders, production companies."
 
Article 55 shall be changed to Article 60, Article 56 shall be changed to Article 61, and the “price competent department” shall be amended to be “the competent authority for drug prices”, and the “production enterprise” shall be modified. It is a “listing license holder and production company”.
 
Article 68 is changed to Article 78, Article 70 is changed to Article 80, Article 71 is changed to Article 82, and the “pharmaceutical production enterprise” is changed to “pharmaceutical listing” License holders, pharmaceutical manufacturers."
 
Article 90 shall be changed to Article 105, and the “production enterprise” in the first paragraph shall be revised to “listing license holder and production enterprise”, and the “pharmaceutical production enterprise” in the second paragraph shall be revised to “ Drug listed license holders, pharmaceutical manufacturers."
 
7. Article 11 is changed to Article 13 and one paragraph is added as the second paragraph: “To produce medicines, suppliers shall be examined for raw materials and auxiliary materials in accordance with the regulations, and raw materials and auxiliary materials purchased and used shall be guaranteed to meet the requirements. Requirements and requirements of the "Good Manufacturing Practices"."
 
8. Article 12 shall be changed to Article 14 and amended as: “The holders of drug marketing licenses and pharmaceutical production enterprises must conduct quality inspections and audits of pharmaceuticals; they do not meet the national drug standards or do not follow the people of provinces, autonomous regions and municipalities directly under the Central Government. The Chinese medicine decoction prescriptions formulated by the government drug regulatory authority shall not be manufactured or marketed.
 
"Pharmaceutical production enterprises shall establish procedures for the release of pharmaceutical products, clarify the standards and conditions for ex-factory release, and conduct quality inspections on pharmaceuticals; if they meet the standards and conditions, they may be released after being signed by the person in charge of quality.
 
“The holder of the drug marketing license shall establish a drug listing release procedure, and review the drug released by the drug manufacturer, and release it after being signed by the quality person in charge.”
 
9. Delete Article 13. X. Article 14 shall be changed to Article 15 and the “Local Drug Supervision and Administration Department at or above the county level” in the first paragraph shall be revised to “the department responsible for drug supervision and administration of the local people's government at or above the county level”. The "Article 15" in the amendment was changed to "Article 16".
 
11. Article 15 shall be changed to Article 16 and the fourth item shall be amended to read as follows: “The rules and regulations guaranteeing the quality of the drugs handled by the State Council shall be in accordance with the “Quality Management Standards for Pharmaceutical Products” formulated by the drug regulatory authority under the State Council in accordance with this Law. "The requirements".
 
XII. Article 16 is changed to Article 17 and revised as follows: “To engage in pharmaceutical business activities, it must comply with the “Good Manufacturing Practices for Pharmaceuticals”, establish and improve the management system for operation quality, and ensure that the entire process of pharmaceutical operations continues to meet statutory requirements.
 
“The legal representative or principal responsible person of the pharmaceutical business enterprise is fully responsible for the pharmaceutical business activities of the enterprise.”
 
XIII. Article 29 is changed to Article 30 and revised as follows: "To develop new drugs, relevant information such as development methods, quality indicators, pharmacological and toxicological test results must be truthfully submitted in accordance with the provisions of the drug regulatory authority under the State Council. Samples may only be clinically tested after approval by the drug regulatory authority under the State Council. The drug regulatory department of the State Council shall decide whether to approve and notify the applicant within 60 working days from the date of accepting the application for clinical trial; As consent.
 
"The clinical trials of drugs should be carried out in clinical trial institutions with corresponding conditions. Drug clinical trial institutions are subject to record management, and the specific measures are jointly formulated by the drug regulatory department of the State Council and the health administrative department of the State Council."
 
XIV. Article 31 shall be changed to Article 32 and amended to read: “Drugs produced and sold in China shall be subject to the approval of the drug regulatory authority under the State Council, except for Chinese herbal medicines and Chinese herbal medicines that have not been subject to examination and approval. .
 
The catalogue of Chinese herbal medicines and traditional Chinese medicine decoction pieces subject to examination and approval shall be formulated by the drug regulatory department of the State Council in conjunction with the Chinese medicine administration department of the State Council. When examining and approving the drug regulatory department of the State Council, in addition to reviewing the safety and effectiveness of drugs, the applicant shall also review the applicants' ability to ensure the safety and effectiveness of drugs, such as quality management, risk prevention and control, and liability compensation. Issue a drug registration certificate. If the drug registration certificate is obtained, it is the holder of the drug marketing license.
 
"If the holder of the drug marketing license is an overseas enterprise, it shall set up a representative office in China or designate a domestic legal person as an agent to perform the obligations of the holder of the drug listing permit and jointly assume the responsibility of the holder of the drug marketing permit.
 
"Chinese medicine decoction piece production enterprises fulfill the relevant obligations of holders of drug marketing licenses, and are responsible for the production, sales and adverse reaction reports of traditional Chinese medicine decoction pieces; establish a traceability system for the quality of traditional Chinese medicine decoction pieces, and implement the whole process management of the production and sales of traditional Chinese medicine decoction pieces to ensure the Chinese medicine Pieces are safe and effective.
 
“The legal representative or principal responsible person of the drug marketing license holder is fully responsible for the quality of the drug.
 
The specific management measures for holders of drug marketing licenses shall be formulated by the drug regulatory authority under the State Council.
 
15. Add one as Article 33: “Where the holder of a drug marketing permit produces its own medicine, it shall obtain the “Pharmaceutical Production License” in accordance with the provisions of this Law; if it is entrusted to produce, it shall select a qualified pharmaceutical production enterprise. Vaccines, blood products, narcotic drugs, psychotropic drugs, and medical toxic drugs shall not be entrusted to production; however, the State Council's drug regulatory authority may stipulate that production may be entrusted.
 
"If the holder of the drug marketing license manages the drug by himself, he shall have the conditions for the operation of the drug as stipulated in this Law; if entrusted to operate, he shall select the drug business enterprise that meets the requirements."
 
16. Add one as Article 34: “The holder of a drug marketing license shall formulate a drug risk management and control plan and establish an annual reporting system. Each year, the drug production and sales, post-marketing research, risk management, etc. shall be Report of the drug supervision and administration department of the people's government of the autonomous region or municipality directly under the Central Government."
 
17. Add one, as Article 35: “The holders of drug listings, production enterprises, operating enterprises, and medical institutions shall establish and implement strict drug quality and safety traceability systems to ensure traceability of drugs.
 
"In the process of development, production, circulation and vaccination of vaccines, informational means should be used to collect and retain traceability information."
 
18. Add one as Article 36: “The State implements a compulsory insurance system for vaccine liability. The holder of the marketing license for the vaccine shall be insured in accordance with relevant state regulations.”
 
19. Article 32 shall be changed to Article 37, and the “Article 10” in the first paragraph shall be amended to “Article 12”, and the third paragraph shall be amended as: “The drug regulatory department of the State Council The health administrative department of the State Council organizes the Pharmacopoeia Commission to be responsible for the formulation and revision of national drug standards."
 
20. Article 33 shall be changed to Article 38, and one paragraph shall be added as the second paragraph: "The holder of the drug marketing license shall, in accordance with the requirements of the drug regulatory authority under the State Council, be safe and effective for the drugs listed. Sexual re-evaluation."
Twenty-one, Article 34 is changed to Article 39, and is amended as: “The holder of drug marketing license, drug manufacturing enterprise, pharmaceutical trading enterprise, medical institution must obtain the drug from the drug marketing license holder or have drug production. The enterprises that are qualified to purchase the drugs; however, except for the purchase of Chinese herbal medicines that have not been subject to examination and approval management."
 
22. Article 39 shall be changed to Article 44, and the “Import Drug Registration Certificate” in the first paragraph shall be revised to “Drug Registration Certificate”.
 
Article 42 shall be changed to Article 47, and the “Approval Document Number or Imported Drug Registration Certificate” shall be revised to “Drug Registration Certificate”.
 
Article 23: Article 40 shall be changed to Article 45, and the “drug supervision and administration department at the port location” in the first and second paragraphs shall be revised to “the department responsible for drug supervision and administration at the port location”, and the In the second paragraph, "and the inspection fee shall be charged in accordance with the provisions of paragraph 2 of Article 41 of this Law."
 
24. Article 41 is changed to Article 46 and the second paragraph is deleted. Twenty-fifth, Article 43 is changed to Article 48, and revised as: “The State implements a drug reserve system and establishes drug reserves at the central and local levels. “The holders of marketing and shortage drugs have ceased production. It shall report to the drug regulatory department of the State Council in accordance with the regulations. “When major disasters, epidemics and other emergencies occur in China, the departments designated by the State Council can urgently call for corporate drugs.”
 
Articles 26 and 48 shall be changed to Article 53 and the third paragraph of Article 3 shall be amended to read as follows: “Use of unapproved raw materials for drug production that must be approved according to law”.
 
Article 27 and Article 61 shall be changed to Article 66 and revised as: "The market supervision and administration department shall, in accordance with the provisions of the advertising management laws and regulations, inspect drug advertisements and investigate illegal acts."
 
Twenty-eighth, Article 63 is changed to Article 68, and is amended as: "The drug regulatory authority has the right to produce, operate, and medically report drugs that have been approved for examination and approval in accordance with laws and administrative regulations. The organization shall supervise and inspect the use of drugs. If necessary, it may conduct extended inspections on the units and individuals that provide products or services for the development, production, operation and use of drugs. The relevant units and individuals may not refuse or conceal.
 
"The drug regulatory authority shall implement key supervision and inspection of biological products such as vaccines.
 
"If it is found that there may be potential safety hazards, the drug supervision and administration department may, according to the supervision and inspection, take measures such as warning, responsibility interview, rectification within a time limit, order recall, suspension of production, sales, use, import, etc., and timely announce the results of inspection and treatment." When the drug supervision and administration department conducts supervision and inspection, it must present the certification documents, and the technical secrets and business secrets of the inspected persons who are aware of the supervision and inspection shall be kept confidential. ”
 
Twenty-nine, Article 67 shall be changed to Article 72, and shall be amended as: "The drug regulatory authority shall implement the "Good Manufacturing Practices for Pharmaceutical Production" and the "Production Quality Management Regulations" and "Management Enterprises". The quality management regulations of pharmaceutical products are checked and supervised, and they continue to meet the requirements."
 
30. Add one as Article 73: “The State establishes a team of pharmaceutical professional inspectors. Inspectors should have drug laws, regulations and professional knowledge.”
 
Thirty-one, add one, as Article 74: "The drug regulatory authority establishes a drug listing license holder, a production enterprise, a business enterprise, a medical institution drug safety credit file, records the licensing, daily supervision and inspection results, The investigation and punishment of illegal acts shall be announced to the public in accordance with the law and updated in real time; for those with bad credit records, the frequency of supervision and inspection shall be increased; if the circumstances of the illegal acts are serious, joint punishment shall be implemented according to the regulations."
 
Thirty-two, add one, as Article 75: "The drug supervision and administration department shall publish the e-mail address and telephone number of the department, accept consultation, complaints, reports, and promptly reply, verify and handle according to law. The verification is true. Report and reward the reporter according to the relevant regulations.
 
"The drug regulatory authority shall keep confidential the information of the reporter and protect the legitimate rights and interests of the informant."
 
Thirty-three, add one, as Article 76: "The state implements a unified system for the publication of drug safety information. The overall situation of national drug safety, drug safety risk warning information, major drug safety accidents and their investigation and processing information and the State Council determine the need to unify Other information published by the State Council shall be uniformly announced by the drug regulatory authorities of the State Council. The impact of drug safety risk warning information and major drug safety incidents and their investigation and processing information is limited to specific regions, and may also be handled by the relevant provinces, autonomous regions, and municipalities directly under the central government. Announced. The above information may not be released without authorization.
 
"The publication of drug safety information should be accurate and timely, and make necessary explanations to avoid misleading.
 
"No unit or individual may fabricate or distribute false drug safety information."
 
Thirty-four, add one, as Article 77: "The drug regulatory authorities have not found the systemic risk of drug safety in a timely manner, and have not timely eliminated the hidden dangers of drug safety in the area under supervision and management, and the drug supervision of the people's government at the same level or the people's government at a higher level. The management department conducts responsibility interviews with its principals.
 
"If the local people's government fails to fulfill its drug safety duties and fails to eliminate potential major drug safety risks in a timely manner, the higher-level people's government or the drug supervision and administration department of the higher-level people's government shall conduct responsibility interviews with its principal responsible persons.
 
"The departments and local people's governments that have been interviewed should immediately take measures to rectify the drug supervision and management work.
 
“Responsibility interviews and rectifications should be included in the appraisal and assessment records of drug supervision and management work of local people's governments and relevant departments.”
 
35. Add one, as Article 81: "If there are quality problems or other potential safety hazards in the listed drugs, the holder of the drug marketing permit shall immediately stop production and sales, and inform the relevant production enterprises, operating enterprises and medical institutions to stop. Production, operation and use, recall of drugs that have been on the market, promptly and publicly recall information, and report the recall and handling of drugs to the drug regulatory authorities and health administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government. Pharmaceutical production enterprises and pharmaceutical enterprises Medical institutions should cooperate.
 
"If the holder of the drug marketing license should recall the drug in accordance with the law without a recall, the drug regulatory authority of the people's government of the province, autonomous region or municipality directly under the Central Government shall order it to recall."
 
36. Article 72 shall be changed to Article 83 and revised as: “The drug production license or the drug business license” or the “medical institution preparation license” has not been obtained. , banned according to law, confiscation of illegally produced and sold drugs and illegal gains, and the illegal production and sale of drugs (including sold and unsold drugs, the same below) value of goods more than five times more than ten times Fines; if the circumstances are serious, and impose a fine of ten times or more and thirty times less than the value of the illegally produced or sold drugs; if the crime is constituted, criminal responsibility shall be investigated according to law."
 
37. Article 73 shall be changed to Article 84 and revised as: "If the production or sale of counterfeit medicines is carried out, the illegally produced and sold drugs and illegal proceeds shall be confiscated, and the production shall be suspended, the business shall be suspended, and the drug approval certificate shall be issued. It shall be revoked and imposed a fine of not less than two times and ten times the value of the drug produced or sold illegally; if the circumstances are serious, the fine shall be punishable by the illegal production and sale of the drug value of ten times or more and 30 times or less. Production License, Drug License, or Medical Device Preparation License; if a crime is constituted, criminal responsibility shall be investigated according to law."
 
38. Article 74 shall be changed to Article 85 and amended as: "If the production or sale of inferior drugs is made, the illegally produced and sold drugs and illegal proceeds shall be confiscated, and the value of the drug produced and sold illegally shall be a fine of not more than five times the sum; if the circumstances are serious, and impose a fine of not more than five times and fifteen times the value of the illegal production and sale of drugs, order to suspend production, suspend business for rectification until the drug approval certificate is revoked, and the drug production license is revoked. ", "Drug Business License" or "Medical Agency Preparation License"; if it constitutes a crime, criminal responsibility shall be investigated according to law."
 
39. Article 75 shall be changed to Article 86, and the first paragraph shall be amended to read as follows: “The enterprise or other unit engaged in the production and sale of counterfeit drugs and the production or sale of inferior drugs, and its legal representative Or the principal person in charge, the directly responsible person in charge, and other directly responsible personnel shall confiscate the income earned from the unit during the period of the illegal act and the fine of 30% or more of the income of the office, and shall not engage in drug production for life. And operating activities."
 
Articles 70 and 76 shall be changed to Article 87 and amended as: "If you know or should know that it is a counterfeit and inferior drug and provide convenient conditions for transportation, storage, storage, etc., all transportation, storage and storage shall be confiscated. The income shall be a fine of more than one time and not more than five times the illegal income; if the circumstances are serious, the fine shall be imposed between five times and fifteen times the illegal income; if the crime is constituted, the criminal responsibility shall be investigated according to law."
Forty-one, and Article 78 shall be changed to Article 89 and revised as: “The holder of the drug for marketing, the manufacturer, the enterprise, the non-clinical safety evaluation research institution, the drug clinical trial institution, etc. In accordance with the provisions of the "Pharmaceutical Production Quality Management Regulations", "Pharmaceutical Management Quality Management Regulations", "Non-Clinical Research Quality Management Regulations", "Pharmaceutical Clinical Trial Quality Management Regulations", the order shall be corrected within a time limit; if it is not corrected within the time limit, it shall be ordered to suspend production. If the circumstances are serious, a fine of not less than 100,000 yuan but not more than 500,000 yuan shall be imposed, and the drug approval certificate shall be revoked, and the "Pharmaceutical Production License" and " The Pharmaceutical Business License, non-clinical safety evaluation research institutions, drug clinical trial institutions, etc. shall not conduct drug non-clinical safety evaluation studies or drug clinical trials within five years, and shall be directly responsible to the legal representative or principal responsible person of the unit. Supervisors and other directly responsible personnel, confiscation of their income from the unit during the period of the violation And impose a fine of more than income gained ten percent to 50 percent, depending on the circumstances prohibit a decade until its lifetime engaged in pharmaceutical production and business activities; constitute a crime, be held criminally responsible. "
 
42. Article 79 shall be changed to Article 90 and amended as: "The holder of a drug listed in the market, a manufacturer, a business enterprise or a medical institution purchases drugs in violation of the provisions of Article 39 of this Law. Responsible for correction, confiscation of illegally purchased drugs and illegal gains, and a fine of more than two times and ten times the amount of illegally purchased drugs; if the circumstances are serious, the amount of illegally purchased drugs is more than ten times A fine of less than 2 times, the drug approval certificate shall be revoked, and the Pharmaceutical Production License, Drug License, or Medical Organization License shall be revoked.
 
Forty-one, add one, as Article 91: "The holder of a drug marketing license violates the provisions of this Law. If a drug risk control plan is not formulated or an annual report is not submitted, it shall be ordered to make corrections within a time limit; if it is overdue, it shall be corrected. A fine of not less than 10,000 yuan but not more than 200,000 yuan."
 
Forty-fourth, add one, as Article 92: "A holder of a drug marketing license shall, after being ordered to recall by the drug regulatory authority of the people's government of a province, autonomous region or municipality directly under the Central Government, refuse to recall it, the amount of the drug value shall be recalled. a fine of five times or more and ten times or less; if the value of the goods is less than 10,000 yuan, a fine of not less than 50,000 yuan but not more than 100,000 yuan; if the circumstances are serious, the drug approval certificate shall be revoked, and the drug production license and drug shall be revoked. Business license. If a pharmaceutical production enterprise, a pharmaceutical business enterprise or a medical institution refuses to cooperate with the recall, it shall be imposed a fine of not less than 20,000 yuan but not more than 100,000 yuan."
 
Forty-five, add one, as Article 93: "Where the drug-licensing license holder, production enterprise, business enterprise, medical institution hired personnel violates the provisions of this Law, it is ordered to be dismissed, and it is 50,000 yuan to 200,000 yuan. A fine below the yuan."
 
Forty-sixth and 80th shall be changed to Article 94, and the “drug supervision and administration department at the port location” shall be revised to “the department responsible for drug supervision and administration at the port location”, and the “drug import registration certificate” shall be included therein. The “Imported Drug Registration Certificate” was revised to “Drug Registration Certificate”.
 
47. Article 81 shall be changed to Article 95 and amended to read: "Forgery, alteration, sale, lease, lending license or drug approval certificate, confiscation of illegal income and double the illegal income A fine of not more than five times; if there is no illegal income, a fine of not less than 50,000 yuan but not more than 150,000 yuan; if the circumstances are serious, the fine of not more than five times and fifteen times the illegal income shall be revoked, the seller, the lessor, and the loan shall be revoked. Party's "Pharmaceutical Production License", "Pharmaceutical Business License", "Medical Agency Preparation License" or the withdrawal of the drug approval certificate; if a crime is constituted, criminal responsibility shall be investigated according to law."
 
Forty-eighth, Article 82 shall be changed to Article 96, and shall be amended as: "In violation of the provisions of this Law, provide false certificates, documents, samples or other deceptive means to obtain the "Pharmaceutical Production License" and "Pharmaceutical Business License""Certificate", "Medical Agency Preparation License" or drug approval certificate, revoke the "Drug Production License", "Drug Business License", "Medical Agency Preparation License" or cancel the drug approval certificate, and will not accept it within ten years. The application is subject to a fine of not less than 100,000 yuan but not more than 300,000 yuan."
 
Forty-nine, and Article 83 shall be changed to Article 97, and shall be amended as follows: "If a medical institution sells its prepared preparations in the market, it shall be ordered to make corrections, confiscate the illegally sold preparations and illegal proceeds, and be disposed of illegally. A fine of more than one time to five times the value of the goods; if the circumstances are serious, a fine of not less than five times and fifteen times the value of the illegally sold preparations shall be imposed."
 
50. Article 85 shall be changed to Article 99 and amended to read: "If the drug label does not comply with the provisions of Article 59 of this Law, it shall be ordered to make corrections, except that it shall be treated in accordance with the law according to counterfeit drugs or inferior drugs. Give a warning; if the circumstances are serious, cancel the registration certificate for the drug."
 
Fifty-one, add one, as Article 100: "If one of the following acts is imposed, it shall be severely punished within the penalty range prescribed by this Law: "(1) Anesthetic drugs, psychotropic drugs, medical toxic drugs, radioactive drugs Pretending to be a drug or pretending to be a drug with other drugs; "(2) Producing and selling counterfeit or inferior drugs that are mainly used by pregnant women, infants and children; "(3) Vaccines produced and sold, etc. Biological products belong to counterfeit or inferior drugs; "(4) the production and sale of counterfeit drugs and inferior drugs, causing the consequences of personal injury; "(5) the production and sale of counterfeit drugs and inferior drugs, which are re-offended after being processed;" 6) Refusing, evading supervision and inspection, or forging, destroying or concealing relevant evidence materials, or arbitrarily using them to seal up and seize articles."
 
52. Article 87 shall be changed to Article 102 and amended as: "The administrative penalties prescribed in Articles 83 to 101 of this Law shall be subject to the drug supervision and administration of the State Council in accordance with the drug supervision of the State Council. The division of responsibilities as stipulated by the management department; the revocation of the "pharmaceutical production license", "drug business license", "medical institution preparation license", medical institution practice license or withdrawal of the drug approval certificate, the original issuance and approval The department decided."
 
Article 53 and Article 89 shall be changed to Article 104, and shall be amended as: “The holders of listed drugs, production enterprises, operating enterprises, and medical institutions secretly give, receive or receive rebates or other benefits in the purchase and sale of drugs. If the holder of the drug, the manufacturer of the drug, the operating enterprise or its agent gives the person in charge of the medical institution using the drug, the drug purchaser, the physician, etc. the property or other interests, the market supervision and management department Where a fine of not less than 10,000 yuan but not more than 200,000 yuan is imposed, if there is illegal income, it shall be confiscated; if the circumstances are serious, the market supervision and administration department shall revoke the business license of the drug listing permit holder, the pharmaceutical production enterprise, and the pharmaceutical business enterprise, and The drug regulatory department shall be notified to the drug regulatory authority to revoke the drug approval certificate and revoke its Pharmaceutical Production License and Drug Business License; if a crime is constituted, criminal responsibility shall be investigated according to law.
 
"Where the drug listed license holder, production enterprise or business enterprise pays bribes to the state staff in the development, production and operation of the drug, its legal representative or principal responsible person, directly responsible person in charge and other directly responsible personnel shall not be allowed for life. Engaged in the production and operation of pharmaceuticals; if it constitutes a crime, it shall be investigated for criminal responsibility according to law."
 
Article 54. Article 93 shall be changed to Article 108 and amended as: "If the drug regulatory authority violates the provisions of this Law and has one of the following acts, the competent authority at its higher level shall order it to recover the certificate issued in violation of the law. The drug approval certificate shall be revoked, and the directly responsible person in charge and other directly responsible personnel shall be given administrative sanctions according to law; if a crime is constituted, criminal responsibility shall be investigated according to law: “(1) A drug production license is issued to a unit that does not meet the statutory conditions. ", "Pharmaceutical Business License" or "Medical Agency Preparation License"; "(2) Issue a drug registration certificate for drugs that do not meet the import conditions; "(3) Approved for clinical trials without conditions Issued a drug registration certificate. ”
 
Fifty-fifth, Article 94 shall be changed to Article 109, and the "or supervisory authority" shall be deleted.
 
56. Add one article as Article 113: "In case of violation of the provisions of this Law, if the local people's government at or above the county level has one of the following acts, the person directly in charge and other directly responsible personnel shall be given a record or record. If the circumstances are serious, demotion, dismissal or dismissal shall be given: "(1) Failure to perform duties, causing serious adverse effects or major losses; "(2) concealing, falsely reporting, or delaying the reporting of drug safety accidents;" c) A particularly serious drug safety accident occurs within the administrative area, or a major drug safety accident occurs continuously. ”
 
57. Add one as Article 144: "In case of violation of the provisions of this Law, if the drug supervision and administration department has one of the following acts, the directly responsible person in charge and other directly responsible personnel shall be given a record or remembered. Disciplinary action; if the circumstances are serious, demotion or dismissal shall be given; if the circumstances are serious, the dismissal shall be given:
 
"(1) concealing, falsely reporting, or delaying the reporting of drug safety accidents; "(2) failing to investigate and deal with the discovered drug safety violations in a timely manner; "(3) failing to perform drug supervision and management duties, causing serious adverse effects or major losses. ”
 
58. Article 7 is changed to Article 9 and the “Article 8” is changed to “Article 10”.
 
Article 77 is changed to Article 88, and “Article 48” is amended to “Article 53” and “Article 49” is amended to “Article 54”.
 
Article 84 is changed to Article 98, and “Article 18” is amended to “Article 19” and “Article 19” is amended to “Article 20”.
 
Article 88 shall be changed to Article 103, and “Article 55” shall be amended to “Article 60” and “Article 56” shall be amended to “Article 61”.
 
In addition, the order of the articles was adjusted accordingly.