Implementation Regulations of the Pharmaceutical Administration Law of the People's Republic of China

　　(Promulgated by the State Council Order No. 360 of the People's Republic of China on August 4, 2002; First Amendment based on the State Council's Decision on Amending Certain Administrative Regulations on February 6, 2016; Second Amendment based on the State Council's Decision on Amending Certain Administrative Regulations on March 2, 2019; Third Amendment based on the State Council's Decision on Amending and Repealing Certain Administrative Regulations on December 6, 2024)

Chapter 1 General Provisions

　　Article 1 These Regulations are formulated in accordance with the Pharmaceutical Administration Law of the People's Republic of China (hereinafter referred to as the "Pharmaceutical Administration Law").

　　Article 2 The State Council's drug supervision and administration department shall establish a national pharmaceutical inspection institution.

　　The drug supervision and administration departments of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government may establish pharmaceutical inspection institutions within their respective administrative regions. The setting-up plan for local pharmaceutical inspection institutions shall be proposed by the drug supervision and administration departments of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government and submitted to the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government for approval.

　　The drug supervision and administration departments of the State Council and the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government may, as needed, designate testing institutions that meet the conditions for pharmaceutical testing to undertake pharmaceutical testing work.

Chapter 2 Management of Pharmaceutical Production Enterprises

　　Article 3 To establish a pharmaceutical production enterprise, the applicant shall submit an application to the drug supervision and administration department of the people's government of the province, autonomous region, or municipality directly under the Central Government where the enterprise is to be located. The drug supervision and administration department of the people's government of the province, autonomous region, or municipality directly under the Central Government shall, within 30 working days from the date of receipt of the application, organize an acceptance inspection in accordance with the opening conditions stipulated in Article 8 of the Pharmaceutical Administration Law; for those that pass the acceptance inspection, a Pharmaceutical Production License shall be issued.

　　Article 4 If a pharmaceutical production enterprise changes the licensed matters of its Pharmaceutical Production License, it shall apply for a change registration of the Pharmaceutical Production License to the original issuing authority 30 days before the change of the licensed matters; no changes to the licensed matters shall be made without approval. The original issuing authority shall make a decision within 15 working days from the date of receipt of the application.

　　Article 5 Drug supervision and administration departments of people's governments at or above the provincial level shall organize the certification of pharmaceutical production enterprises in accordance with the Good Manufacturing Practice for Pharmaceuticals and the implementation methods and steps prescribed by the State Council's drug supervision and administration department; those that meet the Good Manufacturing Practice for Pharmaceuticals shall be issued a certification certificate. The certification of pharmaceutical production enterprises producing injections, radioactive pharmaceuticals, and biological products specified by the State Council's drug supervision and administration department shall be undertaken by the State Council's drug supervision and administration department.

　　The format of the Good Manufacturing Practice for Pharmaceuticals certification certificate shall be uniformly stipulated by the State Council's drug supervision and administration department.

　　Article 6 Newly established pharmaceutical production enterprises, pharmaceutical production enterprises that newly build pharmaceutical production workshops, or those that add new dosage forms, shall apply for Good Manufacturing Practice for Pharmaceuticals certification to the drug supervision and administration department as prescribed within 30 days from the date of obtaining the pharmaceutical production certification document or the date of official production after approval. The drug supervision and administration department that accepts the application shall, within 6 months from the date of receipt of the enterprise's application, organize the certification of whether the applicant enterprise meets the Good Manufacturing Practice for Pharmaceuticals; those that pass the certification shall be issued a certification certificate.

　　Article 7 The State Council's drug supervision and administration department shall establish a pool of Good Manufacturing Practice for Pharmaceuticals certification inspectors. Good Manufacturing Practice for Pharmaceuticals certification inspectors must meet the conditions prescribed by the State Council's drug supervision and administration department. For Good Manufacturing Practice for Pharmaceuticals certification, certification inspectors must be randomly selected from the Good Manufacturing Practice for Pharmaceuticals certification inspector pool to form a certification inspection team for certification inspection in accordance with the provisions of the State Council's drug supervision and administration department.

　　Article 8 The validity period of the Pharmaceutical Production License is 5 years. If an enterprise needs to continue producing pharmaceuticals after the validity period expires, the licensed enterprise shall apply for renewal of the Pharmaceutical Production License 6 months before the expiration of the license's validity period, in accordance with the provisions of the State Council's drug supervision and administration department.

　　If a pharmaceutical production enterprise ceases production of pharmaceuticals or closes down, the Pharmaceutical Production License shall be revoked by the original issuing department.

　　Article 9 The pharmaceutical raw materials used by pharmaceutical production enterprises in the production of pharmaceuticals must have drug approval numbers or import drug registration certificates/pharmaceutical product registration certificates issued by the State Council's drug supervision and administration department; however, this does not apply to Chinese herbal medicines and Chinese herbal medicine slices that are not subject to approval number management.

　　Article 10 In accordance with the provisions of Article 13 of the Pharmaceutical Administration Law, for those who accept the entrustment to produce pharmaceuticals, the entrusted party must be a pharmaceutical production enterprise holding a Good Manufacturing Practice for Pharmaceuticals certification certificate that is suitable for the pharmaceuticals it is entrusted to produce.

　　Vaccines, blood products, and other pharmaceuticals specified by the State Council's drug supervision and administration department shall not be entrusted for production.

Chapter 3 Management of Pharmaceutical Business Enterprises

　　Article 11 To establish pharmaceutical wholesale enterprises and pharmaceutical retail enterprises, applications for pharmaceutical business licenses shall be submitted in accordance with the provisions of the Pharmaceutical Administration Law, and materials proving that they meet the conditions stipulated in the Pharmaceutical Administration Law shall be submitted.

　　Article 12 An administrative licensing decision shall be made within 20 working days from the date of receipt of the application for a pharmaceutical business license. For those that meet the prescribed conditions, a license shall be granted and a Pharmaceutical Business License shall be issued; for those that do not meet the prescribed conditions, a license shall not be granted, and the reasons shall be stated in writing.

　　Article 13 The drug supervision and administration departments of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government and the drug supervision and administration institutions of cities under the jurisdiction are responsible for organizing the certification of pharmaceutical business enterprises. Pharmaceutical business enterprises shall obtain certification certificates through the Good Pharmaceutical Distribution Practice certification organized by the drug supervision and administration departments of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government or the drug supervision and administration institutions of cities under the jurisdiction, in accordance with the implementation methods and steps prescribed by the State Council's drug supervision and administration department. The format of the Good Pharmaceutical Distribution Practice certification certificate shall be uniformly stipulated by the State Council's drug supervision and administration department.

　　Newly established pharmaceutical wholesale enterprises and pharmaceutical retail enterprises shall apply for Good Pharmaceutical Distribution Practice certification to the drug supervision and administration department or drug supervision and administration institution that issued their Pharmaceutical Business License within 30 days from the date of obtaining the Pharmaceutical Business License. The drug supervision and administration department or drug supervision and administration institution that accepts the application shall, within 3 months from the date of receipt of the application, organize the certification of whether the pharmaceutical wholesale enterprise or pharmaceutical retail enterprise applying for certification meets the Good Pharmaceutical Distribution Practice, in accordance with the provisions of the State Council's drug supervision and administration department; those that pass the certification shall be issued a certification certificate.

　　Article 14 The drug supervision and administration departments of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government shall establish a pool of Good Pharmaceutical Distribution Practice certification inspectors. Good Pharmaceutical Distribution Practice certification inspectors must meet the conditions prescribed by the State Council's drug supervision and administration department. For Good Pharmaceutical Distribution Practice certification, certification inspectors must be randomly selected from the Good Pharmaceutical Distribution Practice certification inspector pool to form a certification inspection team for certification inspection in accordance with the provisions of the State Council's drug supervision and administration department.

　　Article 15 The State implements a classification management system for prescription drugs and non-prescription drugs. The State classifies non-prescription drugs into Class A non-prescription drugs and Class B non-prescription drugs according to the safety of the non-prescription drugs.

　　Pharmaceutical retail enterprises that operate prescription drugs and Class A over-the-counter drugs should have a registered pharmacist or other pharmaceutical technician legally qualified. Pharmaceutical retail enterprises that operate Class B over-the-counter drugs should have business personnel who have passed the assessment organized by the municipal drug supervision and administration agency or the county-level drug supervision and administration agency directly established by the provincial, autonomous region, or municipality directly under the Central Government's drug supervision and administration department.

　　Article 16 If a pharmaceutical enterprise changes the licensed matters of the "Pharmaceutical Business License," it should apply for a change registration of the "Pharmaceutical Business License" to the original issuing authority 30 days before the change of the licensed matters; the licensed matters shall not be changed without approval. The original issuing authority shall make a decision within 15 working days from the date of receiving the application from the enterprise.

　　Article 17 The "Pharmaceutical Business License" is valid for 5 years. If the licensee needs to continue operating pharmaceuticals after the validity period expires, the licensee should apply for a renewal of the "Pharmaceutical Business License" 6 months before the expiration of the license, in accordance with the regulations of the State Council's drug supervision and administration department.

　　If a pharmaceutical enterprise terminates its pharmaceutical business or closes down, the "Pharmaceutical Business License" shall be revoked by the original issuing authority.

　　Article 18 In remote areas with inconvenient transportation and no pharmaceutical retail enterprises in the urban and rural market, local pharmaceutical retail enterprises, after approval by the county (city) drug supervision and administration agency and registration with the industrial and commercial administrative department, may set up points in the urban and rural market and sell over-the-counter drugs within the approved scope of operation.

　　Article 19 Pharmaceutical production enterprises, pharmaceutical business enterprises, and medical institutions that conduct pharmaceutical transactions through the Internet, and the pharmaceuticals involved in the transactions, must comply with the provisions of the "Pharmaceutical Administration Law" and these Regulations. The management measures for Internet pharmaceutical transaction services shall be formulated by the State Council's drug supervision and administration department in conjunction with the relevant departments of the State Council.

Chapter 4 Pharmaceutical Management of Medical Institutions

　　Article 20 If a medical institution establishes a preparation room, it should submit an application to the health administrative department of the people's government of the province, autonomous region, or municipality directly under the Central Government, and after approval, it should be submitted to the drug supervision and administration department of the same level for approval; after the drug supervision and administration department of the people's government of the province, autonomous region, or municipality directly under the Central Government has passed the acceptance inspection, it shall be approved and a "Medical Institution Preparation License" shall be issued.

　　The health administrative department and the drug supervision and administration department of the people's government of the province, autonomous region, or municipality directly under the Central Government shall make a decision on whether to agree or approve within 30 working days from the date of receiving the application.

　　Article 21 If a medical institution changes the licensed matters of the "Medical Institution Preparation License," it should apply for a change registration of the "Medical Institution Preparation License" to the original reviewing and approving authority 30 days before the change of the licensed matters, in accordance with the provisions of Article 20 of these Regulations; the licensed matters shall not be changed without approval. The original reviewing and approving authority shall make a decision within 15 working days from the date of receiving the application.

　　If a medical institution adds a preparation dosage form or changes the preparation site, it should pass the acceptance inspection of the drug supervision and administration department of the people's government of the province, autonomous region, or municipality directly under the Central Government, and then handle the change registration of the "Medical Institution Preparation License" in accordance with the provisions of the preceding paragraph.

　　Article 22 The "Medical Institution Preparation License" is valid for 5 years. If the medical institution needs to continue preparing preparations after the validity period expires, it should apply for a renewal of the "Medical Institution Preparation License" 6 months before the expiration of the license, in accordance with the regulations of the State Council's drug supervision and administration department.

　　If a medical institution terminates the preparation of preparations or closes down, the "Medical Institution Preparation License" shall be revoked by the original issuing authority.

　　Article 23 Medical institutions preparing preparations must submit relevant materials and samples in accordance with the regulations of the State Council's drug supervision and administration department, and after approval by the drug supervision and administration department of the people's government of the province, autonomous region, or municipality directly under the Central Government, and issuance of a preparation approval number, they may prepare them.

　　Article 24 Preparations prepared by medical institutions shall not be sold or indirectly sold on the market, and shall not publish advertisements for medical institution preparations.

　　In the event of disasters, epidemics, emergencies, or urgent clinical needs and no market supply, with the approval of the State Council or the drug supervision and administration department of the people's government of the province, autonomous region, or municipality directly under the Central Government, preparations prepared by medical institutions may be dispensed among designated medical institutions within a specified period.

　　The dispensing and use of special preparations stipulated by the State Council's drug supervision and administration department, and the dispensing and use of preparations between medical institutions in provinces, autonomous regions, and municipalities directly under the Central Government, must be approved by the State Council's drug supervision and administration department.

　　Article 25 The pharmaceutical personnel who review and dispense prescriptions in medical institutions must be pharmaceutical technicians who have been legally qualified.

　　Article 26 Medical institutions must have true and complete records of purchased pharmaceuticals. The records of purchased pharmaceuticals must indicate the generic name, dosage form, specification, batch number, expiration date, manufacturer, supplier, quantity purchased, purchase price, purchase date, and other contents stipulated by the State Council's drug supervision and administration department.

　　Article 27 The pharmaceuticals provided by medical institutions to patients should be consistent with the scope of diagnosis and treatment, and should be dispensed with the prescription of a registered physician or assistant physician.

　　Family planning technical service institutions purchasing and providing pharmaceuticals to patients should have a scope consistent with the approved service scope, and should be dispensed with the prescription of a registered physician or assistant physician.

　　Individual clinics, clinics, etc., shall not be equipped with pharmaceuticals other than commonly used and emergency pharmaceuticals. The scope and varieties of commonly used and emergency pharmaceuticals shall be stipulated by the health administrative department of the people's government of the province, autonomous region, or municipality directly under the Central Government, in conjunction with the drug supervision and administration department of the same level.

Chapter 5 Pharmaceutical Management

　　Article 28 Drug non-clinical safety evaluation research institutions must implement the "Good Practice Guidelines for Drug Non-clinical Research," and drug clinical trial institutions must implement the "Good Practice Guidelines for Drug Clinical Trials." The "Good Practice Guidelines for Drug Non-clinical Research" and the "Good Practice Guidelines for Drug Clinical Trials" shall be formulated by the State Council's drug supervision and administration department, respectively, in consultation with the State Council's science and technology administrative department and the State Council's health administrative department.

　　Article 29 Drug clinical trials, drug production, and drug import should comply with the "Pharmaceutical Administration Law" and these Regulations, and be reviewed and approved by the State Council's drug supervision and administration department; the State Council's drug supervision and administration department may entrust the drug supervision and administration department of the people's government of the province, autonomous region, or municipality directly under the Central Government to review the research and development situation and conditions of the declared drugs, conduct a formal review of the submitted materials, and test the trial-produced samples. The specific methods shall be formulated by the State Council's drug supervision and administration department.

　　Article 30 The development of new drugs that require clinical trials should be approved by the State Council's drug supervision and administration department in accordance with the provisions of Article 29 of the "Pharmaceutical Administration Law".

　　After the application for drug clinical trials is approved by the State Council's drug supervision and administration department, the applicant should select an institution to undertake the drug clinical trials from among the legally recognized institutions with drug clinical trial qualifications, and file the clinical trial institution with the State Council's drug supervision and administration department and the State Council's health administrative department.

　　Institutions conducting drug clinical trials should inform the subjects or their guardians of the true situation in advance and obtain their written consent.

　　Article 31 The production of drugs with existing national standards should, in accordance with the regulations of the State Council's drug supervision and administration department, submit an application to the drug supervision and administration department of the provincial, autonomous region, or municipality directly under the Central Government, or to the State Council's drug supervision and administration department, submit relevant technical data and provide relevant supporting documents. The drug supervision and administration department of the provincial, autonomous region, or municipality directly under the Central Government shall conduct a review within 30 working days from the date of acceptance of the application, submit its opinions to the State Council's drug supervision and administration department for review, and simultaneously notify the applicant of the review opinions. If the State Council's drug supervision and administration department finds that the application meets the regulations after review, it shall issue a drug approval number.

　　Article 32 Changes to the approved documents and attachments for the development of new drugs, the production of drugs, and the import of drugs should be submitted as a supplementary application to the State Council's drug supervision and administration department; if the State Council's drug supervision and administration department finds that the application meets the regulations after review, it shall approve it. Among them, for changes that do not alter the intrinsic quality of the drug, a supplementary application should be submitted to the drug supervision and administration department of the provincial, autonomous region, or municipality directly under the Central Government; if the drug supervision and administration department of the provincial, autonomous region, or municipality directly under the Central Government finds that the application meets the regulations after review, it shall approve it and report it to the State Council's drug supervision and administration department for the record. Supplementary application items that do not alter the intrinsic quality of the drug shall be formulated by the State Council's drug supervision and administration department.

　　Article 33 Based on the requirements for protecting public health, the State Council's drug supervision and administration department may establish a monitoring period of no more than 5 years for new drug varieties produced by drug manufacturers; during the monitoring period, no other enterprises may be approved for production and import.

　　Article 34 The state protects the independently obtained and undisclosed test data and other data submitted by producers or sellers who have obtained permits for the production or sale of drugs containing new chemical components; no one may make improper commercial use of such undisclosed test data and other data.

　　Within 6 years from the date on which the drug producer or seller obtains the permit for the production and sale of drugs containing new chemical components, the drug supervision and administration department shall not grant a permit to other applicants to use the data in the preceding paragraph to apply for permits for the production and sale of drugs containing new chemical components without the consent of the applicant who has already obtained the permit; however, this does not apply to other applicants who submit data they have independently obtained.

　　Except for the following situations, the drug supervision and administration department may not disclose the data stipulated in paragraph 1 of this article:

　　(1) Public interest requires it;

　　(2) Measures have been taken to ensure that such data will not be improperly used for commercial purposes.

　　Article 35 Drugs applied for import should be drugs that have obtained marketing authorization in the country or region of production; if they have not obtained marketing authorization in the country or region of production, and the State Council's drug supervision and administration department confirms that the drug variety is safe, effective, and clinically necessary, it may be approved for import in accordance with the "Drug Administration Law" and this regulation.

　　Imported drugs should apply for registration in accordance with the regulations of the State Council's drug supervision and administration department. Drugs produced by foreign enterprises can only be imported after obtaining an "Import Drug Registration Certificate", and drugs produced by enterprises in Hong Kong, Macao, and Taiwan can only be imported after obtaining a "Pharmaceutical Product Registration Certificate".

　　Article 36 Medical institutions that need to import a small amount of drugs due to urgent clinical needs should apply to the State Council's drug supervision and administration department with their "Medical Institution Practice License"; they may only import after approval. Imported drugs should be used for specific medical purposes within designated medical institutions.

　　Article 37 After imported drugs arrive at the port, the importing unit should, with the "Import Drug Registration Certificate" or "Pharmaceutical Product Registration Certificate", and the original certificate of origin, copy of the purchase contract, packing list, waybill, freight invoice, factory inspection report, instructions, etc., file it with the drug supervision and administration department at the port of entry. After review by the drug supervision and administration department at the port of entry, if the submitted materials meet the requirements, an "Import Drug Customs Clearance Certificate" shall be issued. The importing unit shall handle customs declaration and release procedures with the "Import Drug Customs Clearance Certificate".

　　The drug supervision and administration department at the port of entry should notify the drug testing institution to conduct random inspections of imported drugs in batches; however, this does not apply to the situations stipulated in Article 41 of the "Drug Administration Law".

　　Article 38 Vaccine products, blood products, in-vitro diagnostic reagents used for blood source screening, and other biological products stipulated by the State Council's drug supervision and administration department should be inspected or approved in accordance with the regulations of the State Council's drug supervision and administration department before sale or import; those that fail inspection or have not been approved may not be sold or imported.

　　Article 39 The state encourages the cultivation of Chinese medicinal materials. For varieties of Chinese medicinal materials that are cultivated and bred in a concentrated and large-scale manner, whose quality can be controlled, and that meet the conditions stipulated by the State Council's drug supervision and administration department, an approval number management system shall be implemented.

　　Article 40 The State Council's drug supervision and administration department shall conduct re-evaluation of drugs that have been approved for production and sale, and based on the results of the re-evaluation, may take measures such as ordering the modification of drug instructions, suspending production and sale, and suspending use; for drugs with serious adverse reactions or other reasons that endanger human health, the drug approval documents should be revoked.

　　Article 41 The validity period of drug approval numbers, "Import Drug Registration Certificates", and "Pharmaceutical Product Registration Certificates" issued by the State Council's drug supervision and administration department is 5 years. If production or import needs to continue after the validity period expires, a re-registration application should be submitted 6 months before the expiration of the validity period. During drug re-registration, relevant materials should be submitted in accordance with the regulations of the State Council's drug supervision and administration department. If re-registration is not applied for after the validity period expires, or if it does not meet the regulations of the State Council's drug supervision and administration department on re-registration after review, the drug approval number, "Import Drug Registration Certificate", or "Pharmaceutical Product Registration Certificate" shall be revoked.

　　The re-registration of drug approval numbers shall be approved by the drug supervision and administration department of the provincial, autonomous region, or municipality directly under the Central Government, and reported to the State Council's drug supervision and administration department for the record; the re-registration of "Import Drug Registration Certificates" and "Pharmaceutical Product Registration Certificates" shall be approved by the State Council's drug supervision and administration department.

　　Article 42 Non-drug products may not be advertised with content related to the prevention, treatment, or diagnosis of human diseases on their packaging, labels, instructions, and related publicity materials; however, this does not apply to situations where laws and administrative regulations stipulate otherwise.

Chapter 6 Management of Drug Packaging

　　Article 43 Packaging materials and containers that directly contact drugs used by drug manufacturers must meet pharmaceutical requirements and standards that ensure human health and safety.

　　The management methods, product catalogs, and pharmaceutical requirements and standards for packaging materials and containers that directly contact drugs shall be formulated and announced by the State Council's drug supervision and administration department.

　　Article 44 The production of Chinese medicine slices should use packaging materials and containers that are suitable for the nature of the drug; Chinese medicine slices with non-compliant packaging may not be sold. The packaging of Chinese medicine slices must be printed with or affixed with labels.

　　The labels of Chinese medicine slices must indicate the name, specifications, place of origin, manufacturer, product batch number, production date, and for Chinese medicine slices under approval number management, the drug approval number must also be indicated.

　　Article 45 Drug packaging, labels, and instructions must be printed in accordance with Article 54 of the "Drug Administration Law" and the regulations of the State Council's drug supervision and administration department.

　　The name of the pharmaceutical product shall comply with the provisions of the State Council's drug supervision and administration department.

　　Article 46 The packaging materials and containers of drugs that directly contact drugs used in the preparation of preparations by medical institutions, and the labels and instructions of the preparations shall comply with the relevant provisions of Chapter VI of the "Pharmaceutical Administration Law" and these Regulations, and shall be approved by the drug supervision and administration department of the people's government of the province, autonomous region, or municipality directly under the Central Government.

Chapter VII Management of Drug Prices and Advertising

　　Article 47 When the government price-regulating department implements drug price monitoring in accordance with the provisions of Article 28 of the "Price Law" to grasp and analyze the changes and trends of drug prices, it may designate some pharmaceutical production enterprises, pharmaceutical business enterprises, and medical institutions as fixed-point units for price monitoring; fixed-point units shall cooperate and support, and truthfully provide relevant information.

　　Article 48 To release drug advertisements, relevant materials shall be submitted to the drug supervision and administration department of the people's government of the province, autonomous region, or municipality directly under the Central Government where the pharmaceutical production enterprise is located. The drug supervision and administration department of the people's government of the province, autonomous region, or municipality directly under the Central Government shall make a decision on whether to issue an approval number for drug advertisements within 10 working days from the date of receipt of the relevant materials; if an approval number for drug advertisements is issued, it shall be filed with the State Council's drug supervision and administration department at the same time. Specific methods shall be formulated by the State Council's drug supervision and administration department.

　　To release advertisements for imported drugs, an application for an approval number for drug advertisements shall be submitted to the drug supervision and administration department of the people's government of the province, autonomous region, or municipality directly under the Central Government where the imported drug agency is located, in accordance with the provisions of the preceding paragraph.

　　For the release of drug advertisements in provinces, autonomous regions, and municipalities directly under the Central Government other than the location of the pharmaceutical production enterprise and the imported drug agency, the enterprise releasing the advertisement shall file the advertisement with the drug supervision and administration department of the people's government of the province, autonomous region, or municipality directly under the Central Government where the advertisement is released before release. If the drug supervision and administration department of the people's government of the province, autonomous region, or municipality directly under the Central Government that accepts the filing finds that the approved content of the drug advertisement does not comply with the regulations on drug advertisement management, it shall be handled by the original issuing department.

　　Article 49 Drugs that have been ordered to suspend production, sales, and use by the State Council or the drug supervision and administration department of the people's government of the province, autonomous region, or municipality directly under the Central Government shall not be advertised during the suspension period; if advertisements have already been released, they must be stopped immediately.

　　Article 50 Drug advertisements that have not been approved by the drug supervision and administration department of the people's government of the province, autonomous region, or municipality directly under the Central Government, advertisements that use forged, misused, or invalid drug advertisement approval numbers, or advertisements whose drug advertisement approval numbers have been revoked due to other illegal advertising activities, must be immediately stopped from being released by the enterprise, advertising operator, and advertising publisher that released the advertisement.

　　For serious violations of the law in releasing drug advertisements, the drug supervision and administration department of the people's government of the province, autonomous region, or municipality directly under the Central Government may issue a public announcement.

Chapter VIII Drug Supervision

　　Article 51 Drug supervision and administration departments (including drug supervision and administration institutions established by the drug supervision and administration department of the provincial people's government in accordance with the law, hereinafter the same) shall supervise and inspect the research, production, operation, and use of drugs in accordance with the law.

　　Article 52 Drug sampling must be carried out by two or more drug supervision inspectors, and shall be carried out in accordance with the regulations of the State Council's drug supervision and administration department; the inspected party shall provide samples for inspection and shall not refuse.

　　If a drug unit that has been subjected to sampling inspection refuses to undergo inspection without justifiable reason, the State Council's drug supervision and administration department and the drug supervision and administration department of the people's government of the province, autonomous region, or municipality directly under the Central Government where the inspected unit is located may announce the suspension of the sale and use of the drugs that the unit refused to inspect.

　　Article 53 For drugs suspected of being adulterated or falsified, when the testing methods and items stipulated in the national drug standards cannot be tested, the drug testing institution may supplement the testing methods and items to conduct drug testing; after approval by the State Council's drug supervision and administration department, the test results obtained using the supplementary testing methods and items may be used as the basis for the drug supervision and administration department to determine the quality of the drugs.

　　Article 54 The drug supervision and administration departments of the State Council and the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government shall regularly issue drug quality announcements based on the results of drug quality sampling inspections. Drug quality announcements shall include the name of the inspected drug, the source of the inspected sample, the production enterprise, the production batch number, the drug specifications, the testing institution, the testing basis, the test results, and the unqualified items. If a drug quality announcement is inappropriate, the issuing department shall correct it within 5 days from the date of confirmation of the inappropriateness of the announcement within the original scope of the announcement.

　　If the party concerned has objections to the test results of the drug testing institution and applies for retesting, it shall submit a written application and the original drug test report to the drug testing institution responsible for retesting. The samples for retesting shall be drawn from the samples retained by the original drug testing institution.

　　Article 55 When a drug supervision and administration department takes administrative compulsory measures such as seizure and impoundment of drugs and their related evidence materials that have been proved to potentially endanger human health in accordance with the law, it shall make a decision on whether to file a case within 7 days from the date of taking the administrative compulsory measures; if testing is required, it shall make a decision on whether to file a case within 15 days from the date of issuance of the test report; if the conditions for filing a case are not met, the administrative compulsory measures shall be lifted; if it is necessary to suspend sales and use, a decision shall be made by the State Council or the drug supervision and administration department of the people's government of the province, autonomous region, or municipality directly under the Central Government.

　　Article 56 No fees shall be charged for drug sampling inspections.

　　If the party concerned has objections to the drug test results and applies for retesting, it shall pay the drug test fees in advance to the retesting institution in accordance with the regulations of the relevant departments of the State Council or the relevant departments of the people's government of the province, autonomous region, or municipality directly under the Central Government. If the retesting conclusion is inconsistent with the original test conclusion, the retesting fees shall be borne by the original drug testing institution.

　　Article 57 Fees may be charged for issuing certificates, registering drugs, certifying drugs, and implementing drug approval testing and mandatory testing in accordance with the provisions of the "Pharmaceutical Administration Law" and these Regulations. Specific charging standards shall be formulated by the State Council's finance department and the State Council's price-regulating department.

Chapter IX Legal Liability

　　Article 58 If pharmaceutical production enterprises and pharmaceutical business enterprises have any of the following circumstances, the drug supervision and administration department shall impose penalties in accordance with the provisions of Article 79 of the "Pharmaceutical Administration Law":

　　(1) For the establishment of pharmaceutical production enterprises, the construction of new pharmaceutical production workshops, and the addition of new production dosage forms, if the "Good Manufacturing Practice for Pharmaceutical Products" certification has not been passed within the time limit stipulated by the State Council's drug supervision and administration department, and pharmaceutical production is still carried out;

　　(2) For the establishment of pharmaceutical business enterprises, if the "Good Supply Practice for Pharmaceutical Products" certification has not been passed within the time limit stipulated by the State Council's drug supervision and administration department, and pharmaceutical business is still carried out.

　　Article 59 For violations of the provisions of Article 13 of the "Pharmaceutical Administration Law" by unauthorized entrustment or acceptance of entrustment for the production of drugs, both the entrusting party and the entrusted party shall be punished in accordance with the provisions of Article 74 of the "Pharmaceutical Administration Law".

　　Article 60 Unauthorized establishment of sales points for drugs in urban and rural market trade markets, or sales of drugs exceeding the approved scope of operation in urban and rural market trade markets, shall be punished in accordance with Article 73 of the Pharmaceutical Administration Law.

　　Article 61 Medical institutions that use preparations prepared by other medical institutions without approval shall be punished in accordance with Article 80 of the Pharmaceutical Administration Law.

　　Article 62 Individual clinics and other medical institutions that provide drugs to patients beyond the prescribed scope and varieties shall be punished in accordance with Article 73 of the Pharmaceutical Administration Law.

　　Article 63 Medical institutions that use fake or substandard drugs shall be punished in accordance with Articles 74 and 75 of the Pharmaceutical Administration Law.

　　Article 64 Unauthorized clinical trials in violation of Article 29 of the Pharmaceutical Administration Law shall be punished in accordance with Article 79 of the Pharmaceutical Administration Law for institutions undertaking drug clinical trials.

　　Article 65 If a drug applicant submits false research methods, quality standards, pharmacological and toxicological test results, and other relevant materials and samples when applying for clinical trials, the State Council's drug supervision and administration department shall not approve the clinical trial of the drug, and shall give a warning to the drug applicant; in serious cases, the applicant shall not be accepted to apply for clinical trials of the same type of drug within 3 years.

　　Article 66 Production of traditional Chinese medicine slices without national drug standards, or failure to comply with the processing standards formulated by the drug supervision and administration departments of the provincial, autonomous region, and municipal people's governments; medical institutions that do not prepare preparations in accordance with the standards approved by the drug supervision and administration departments of the provincial, autonomous region, and municipal people's governments shall be punished in accordance with Article 75 of the Pharmaceutical Administration Law.

　　Article 67 If a drug supervision and administration department or its staff violates regulations and leaks undisclosed test data or other data submitted by producers and sellers to obtain licenses for the production and sale of drugs containing new chemical components, causing losses to the applicant, the drug supervision and administration department shall bear the compensation liability in accordance with the law; after the drug supervision and administration department compensates for the losses, it shall order the staff who acted intentionally or with gross negligence to bear part or all of the compensation costs, and shall give administrative sanctions to the directly responsible personnel in accordance with the law.

　　Article 68 Drugs produced and operated by pharmaceutical production enterprises, pharmaceutical business enterprises, and preparations prepared by medical institutions, whose packaging, labels, and instructions violate the provisions of the Pharmaceutical Administration Law and these Regulations, shall be punished in accordance with Article 86 of the Pharmaceutical Administration Law.

　　Article 69 Pharmaceutical production enterprises, pharmaceutical business enterprises, and medical institutions that change drug production and operation license matters shall go through change registration procedures. Failure to do so shall result in a warning from the original issuing department, and an order to make up for the change registration procedures within a time limit; failure to make up for the procedures after the time limit, the "Drug Production License", "Drug Operation License", and "Medical Institution Preparation License" shall be declared invalid; those who still engage in drug production and operation activities shall be punished in accordance with Article 73 of the Pharmaceutical Administration Law.

　　Article 70 Those who tamper with the approved content of drug advertisements shall be ordered by the drug supervision and administration department to immediately stop the publication of the drug advertisement, and shall be punished by the original approving drug supervision and administration department in accordance with Article 92 of the Pharmaceutical Administration Law.

　　After the drug supervision and administration department revokes the approval number of a drug advertisement, it shall notify the advertising supervision and administration agency within 5 working days from the date of making the administrative processing decision. The advertising supervision and administration agency shall make an administrative processing decision within 15 working days from the date of receiving the notice from the drug supervision and administration department, in accordance with the relevant provisions of the Advertising Law of the People's Republic of China.

　　Article 71 Enterprises that publish drug advertisements in provinces, autonomous regions, or municipalities directly under the Central Government other than the location of the drug production enterprise or the location of the import drug agency, and fail to register with the drug supervision and administration department of the provincial, autonomous region, or municipal people's government in accordance with regulations, shall be ordered by the drug supervision and administration department of the publishing location to rectify within a time limit; failure to rectify after the time limit, the advertisement of the drug in the publishing location shall be stopped.

　　Article 72 Unauthorized publication of drug advertisements without the approval of the drug supervision and administration department of the provincial, autonomous region, or municipal people's government shall be investigated and dealt with by the advertising supervision and administration department upon notification by the drug supervision and administration department after discovery.

　　Article 73 For any of the following acts in violation of the provisions of the Pharmaceutical Administration Law and these Regulations, the drug supervision and administration department shall impose a heavier penalty within the penalty range stipulated in the Pharmaceutical Administration Law and these Regulations:

　　(1) Counterfeiting other drugs with narcotic drugs, psychotropic drugs, medical poisonous drugs, or radioactive drugs, or counterfeiting the above-mentioned drugs with other drugs;

　　(2) Production and sale of fake or substandard drugs mainly used by pregnant women, infants, and children;

　　(3) Biological products and blood products produced and sold are fake or substandard drugs;

　　(4) Production, sale, or use of fake or substandard drugs resulting in personal injury;

　　(5) Production, sale, or use of fake or substandard drugs, and recidivism after processing;

　　(6) Refusal to or evasion of supervision and inspection, or forgery, destruction, or concealment of relevant evidence materials, or unauthorized use of seized or confiscated items.

　　Article 74 The dispatched institutions established by the drug supervision and administration department have the power to make warnings, fines, and confiscation of illegally produced and sold drugs and illegal gains as administrative penalties stipulated in the Pharmaceutical Administration Law and these Regulations.

　　Article 75 If a pharmaceutical business enterprise or medical institution does not violate the relevant provisions of the Pharmaceutical Administration Law and these Regulations, and there is sufficient evidence to prove that it did not know that the drugs sold or used were fake or substandard drugs, the fake or substandard drugs and illegal gains shall be confiscated; however, other administrative penalties may be exempted.

　　Article 76 Confiscated items in accordance with the provisions of the Pharmaceutical Administration Law and these Regulations shall be supervised and processed by the drug supervision and administration department in accordance with regulations.

Chapter 10 Supplementary Provisions

　　Article 77 The meanings of the following terms in these Regulations:

　　Drug qualification certificates and other markings refer to drug production approval documents, drug inspection reports, drug packaging, labels, and instructions.

　　New drugs refer to drugs that have not been marketed in China.

　　Prescription drugs refer to drugs that can only be purchased, dispensed, and used with a prescription from a registered physician or assistant physician.

　　Non-prescription drugs refer to drugs announced by the State Council's drug supervision and administration department that do not require a prescription from a registered physician or assistant physician, and that consumers can judge, purchase, and use on their own.

　　Medical institution preparations refer to fixed-prescription preparations that medical institutions prepare and use for their own clinical needs after obtaining approval.

　　Drug certification refers to the process by which drug supervision and management departments inspect and evaluate the quality management standards implemented by drug research, production, operation, and use units, and decide whether to issue corresponding certification certificates.

　　Drug operation methods refer to drug wholesale and drug retail.

　　Drug operating scope refers to the types of drugs approved for operation by the drug supervision and management department.

　　A drug wholesale enterprise is a drug operating enterprise that sells purchased drugs to drug production enterprises, drug operating enterprises, and medical institutions.

　　A drug retail enterprise is a drug operating enterprise that sells purchased drugs directly to consumers.

　　Article 78: In Article 41 of the "Pharmaceutical Administration Law," "drugs sold in China for the first time" refers to drugs sold in China for the first time by domestic or foreign drug production enterprises, including the same variety produced by different drug production enterprises.

　　Article 79: In Article 59, paragraph 2, of the "Pharmaceutical Administration Law," "prohibiting drug production enterprises, operating enterprises, or their agents from giving, under any name, property or other benefits to the heads of medical institutions, drug procurement personnel, physicians, and other relevant personnel who use their drugs," "property or other benefits" refers to the improper benefits provided by drug production enterprises, operating enterprises, or their agents to the heads of medical institutions, drug procurement personnel, physicians, and other relevant personnel for the purpose of influencing their drug procurement or prescription behavior.

　　Article 80: This regulation shall come into force on September 15, 2002.