(August 4, 2002, the State Council of the People's Republic of China announced No. 360
According to the revision of the State Council Decision on the State Council on February 6, 2016, the State Council No. 666)

Chapter 1 General Principles

1 according to the "Drug Administration Law of the People's Republic of China" (hereinafter referred to as the "Drug Management Law")，Develop this Regulations。

Article 2。
Provincial、Autonomous Region、The Drug Supervision and Administration Department of the People's Government of Municipality directly under the Central Government can set up a stake sports betting apppharmaceutical inspection agency in this administrative area。The setting plan of the local drug inspection agency is provincial、Autonomous Region、The drug supervision and management department of the people's government of the municipality directly under the Central Government is proposed，Report province、Autonomous Region、Approval of the People's Government of the Municipality directly under the Central Government。
State Council and province、Autonomous Region、The drug supervision and management department of the people's government of the municipality directly under the Central Government can be as needed as needed，Determine the inspection institution that meets the drug inspection conditions to undertake the drug inspection work。

Chapter 2 Drug Production Enterprise Management

Article 3 Opening a drug production enterprise，The applicant shall be the province where the proposed enterprise is located、Autonomous Region、The drug supervision and management department of the people's government directly under the Central Government will apply for application。Provincial、Autonomous Region、The drug supervision and management department of the people's government directly under the Central Government shall be within 30 working days from the date of receipt of the application，Conditions and acceptance in accordance with Article 8 of the Drug Management Law;，Send to "Drug Production License"。

Article 4 Drug production enterprise changes the license of the "Drug Production License" permit，It should be changed 30 days before the permit.，Applying for the change of the "Drug Production License" to the original issuing authority;，Do not change the license items。The original certificate agency shall make a decision within 15 working days from the date of receipt of the application。

Article 5 The drug supervision and management departments of the people's government at or above the provincial level shall be in accordance with the implementation measures and implementation steps stipulated by the State Council's Drug Supervision and Administration Department，Organize the certification of pharmaceutical manufacturers; in line with the "Specifications for the Management of Drug Production Quality"，Send to the certification。Where，Production injection、Radiovisual drugs and the certification of pharmaceutical manufacturers stipulated by the drug supervision and management department of the State Council，The drug supervision and management department of the State Council is responsible for。
The format of the certification certificate of the "Quality Management of Drug Production" is uniformly stipulated by the State Council's drug supervision and management department。

6 New pharmaceutical manufacturers、Pharmaceutical manufacturer new pharmaceutical production workshop or new production dosage type，It should be obtained from obtaining a drug production certificate document or within 30 days from the date of approval，Application to the drug supervision and management department for the "Regulations on the Management of Drug Production Quality Management" certification in accordance with regulations。The drug supervision and management department accepted by the application shall be within 6 months from the date of receiving the application of the enterprise，Organization to certify whether the application of the enterprise is in accordance with the "Management of the Quality Management of Drug Production";，Send to the certification。

Article 7 The Drug Supervision and Administration Department of the State Council shall establish a "Drug Production Quality Management Specification" certification inspection office。"Regulations on the Management of Drug Production Quality Management" certified inspectors must meet the conditions prescribed by the State Council's drug supervision and management department。Certificate of "Management of Quality Management of Drug Production"，must，Randomly extract certification inspection team from the "Drug Production Quality Management Specification" certification inspector library for certification inspection team for certification inspection。

Article 8 "Drug Production License" is valid for 5 years。Validity period expires，You need to continue to produce medicines，Certificate enterprise shall 6 months before the permit validity period expires，Apply for a renewal "Drug Production License" in accordance with the provisions of the State Council's Drug Supervision and Administration Department。
Pharmaceutical manufacturers terminate the production of drugs or close，"Drug Production License" is sold by the original certificate department。

9 APIs used by pharmaceutical manufacturers to produce drugs，Drug approval numbers or imported drug registration certificates issued by the Drug Supervision and Administration of the State Council、Registration certificate of pharmaceutical products; but，Traditional Chinese medicinal materials that have not been implemented in the management number management、Except for Chinese medicine tablets。

Article 10 According to Article 13 of the Drug Administration Law，Accepting the commissioned production drugs，The trustees must be a drug manufacturer that holds the "Medicine Quality Management Specifications" certified by the drugs that are compatible with its supporting production。
Vaccine、Blood Products and other drugs stipulated by the State Council's Drug Supervision and Administration Department，Do not entrust production。

Chapter 3 Drug Management Enterprise Management

Article 11 Opening a drug wholesale enterprise，The applicant shall be the province where the proposed enterprise is located、Autonomous Region、The drug supervision and management department of the people's government directly under the Central Government will apply for application。Provincial、Autonomous Region、The drug supervision and management department of the people's government directly under the Central Government shall be within 30 working days from the date of receipt of the application，Decision to make whether the setting standards are agreed to build in accordance with the setting standards stipulated by the Drug Supervision and Administration of the State Council。After the applicant completes the preparation of the proposed enterprise，shall apply to the original approval department for acceptance and acceptance。The original approval department shall be within 30 working days from the date of receiving the application，Organization and acceptance in accordance with Article 15 of the Drug Management Law;，issued to "Drug Business License"。

Article 12 Opening a pharmaceutical retail enterprise，The applicant shall be a municipal drug supervision and management institution or a province in the place where the planned area is located.、Autonomous Region、The county -level pharmaceutical supervision and management agency directly set up by the drug supervision and management department of the people's government of the municipality directly under the Central Government will apply。The drug supervision and management institution accepted the application shall be within 30 working days from the date of receiving the application，According to the regulations of the State Council's drug supervision and management department，Based on the number of local resident population、Region、Traffic conditions and actual needs for review，Make a decision whether to agree to build。After the applicant completes the preparation of the proposed enterprise，It should be applied for acceptance from the original approval agency。The original approval agency shall be within 15 working days from the date of receiving the application，Organization and acceptance in accordance with Article 15 of the Drug Management Law;，issued to "Drug Business License"。

Article 13 province、Autonomous Region、The drug supervision and management department of the people's government of the municipality directly under the Central Government and the city -level drug supervision and management institutions in the district are responsible for organizing the certification work of drug business enterprises。Drug management enterprises shall be in accordance with the implementation measures and implementation steps stipulated by the State Council's Drug Supervision and Management Department，Through province、Autonomous Region、The drug supervision and management department of the people's government directly under the Central Government or the "Quality Management Specification of Medicine Management Quality Management" organized by the city -level pharmaceutical supervision and management institution of the municipality，Get certification。The format of the certification certificate of the "Drug Business Quality Management Specifications" is uniformly stipulated by the State Council's drug supervision and management department。
Newly opened drug wholesale enterprises and pharmaceutical retail companies，It should be within 30 days from the date of obtaining the "Drug Operation License"，The pharmaceutical supervision and management department or drug supervision and management agency issued to its "Drug Operation License" to apply。The pharmaceutical supervision and management department or the drug supervision and management agency that accepts the application shall be within 3 months from the date of receipt of the application，According to the provisions of the State Council's Drug Supervision and Management Department，Organizational certification of drug wholesale enterprises or pharmaceutical retail enterprises applying for certification for certification is certified by the "Drug Business Quality Management Specifications";，Send to the certification。

Article 14 province、Autonomous Region、The drug supervision and management department of the people's government of the municipality directly under the Central Government shall establish a "Drug Operation Quality Management Specification" certification inspection office。"Drug Operation Quality Management Specifications" certified inspectors must meet the conditions stipulated by the Drug Supervision and Administration of the State Council。Certificate of "Specifications for the Management of Drug Business"，must，Randomly extract certification inspectors from the "Drug Business Quality Management Specification" certification inspector library for certification inspection team for certification inspection。

Article 15 The state of the state implemented the management system of prescription drugs and over -the -counter drugs。State's safety according to over -the -counter drugs，Divide non -prescription medicines into category A and non -prescription drugs and category B non -prescription medicines。
Business prescription medicine、Class A non -prescription drug retail enterprise，It should be equipped。Pharmaceutical retail enterprises operating category B non -prescription drugs，It should be equipped with a municipal drug supervision and management institution or province in the viary area、Autonomous Region、The county -level drug supervision and management agency directly set up by the drug supervision and management department of the people's government of the municipality directly under the Central Government。

stake betting appstake online sports bettingArticle 16 Drug operating enterprises change the license of the "Drug Business License" permit，It should be changed 30 days before the permit.，Applying for the change of the "Drug Operation License" to the original certificate agency; not approved，Do not change the license items。The original certificate agency shall make a decision within 15 working days from the date of receiving the application of the enterprise。

Article 17 "Drug Operation License" is valid for 5 years。Validity period expires，You need to continue to operate the medicine，Certificate enterprise shall 6 months before the permit validity period expires，Apply for a renewal "Drug Business License" in accordance with the provisions of the Drug Supervision and Administration Department of the State Council。
Pharmaceutical business enterprises terminate business or close，"Drug Business License" is sold by the original certificate agency。

Article 18 of the remote areas with inconvenient traffic urban and rural areas without pharmaceutical retail companies，Local pharmaceutical retail enterprises are approved by the county (city) drug supervision and management agency and go to the industrial and commercial administrative department for registration.，You can set up points in the urban and rural market trading market and sell non -prescription drugs in the scope of drugs that are approved。

Article 19 Pharmaceutical production enterprises that conduct drug transactions through the Internet、Drug business enterprise、Drugs of medical institutions and their transactions，It must comply with the provisions of the Drug Management Law and these regulations。Administrative measures for Internet drug trading services，Formulated by the State Council's Drug Supervision and Management Department in conjunction with the relevant departments of the State Council。

Chapter 4 Drug Management of Medical Institutions

Article 20 Medical Institutions Establishment Room，It should be provided in the local area、Autonomous Region、The health administrative department of the people's government of the municipality shall apply for application，After reviewing and consent，Approval of the drug supervision and management department of the people's government at the same level; provincial、Autonomous Region、The Pharmaceutical Supervision and Administration of the People's Government of the Municipal Municipality，Approve it，issued to the "Medical Institution Permit License"。
Provincial、Autonomous Region、The health administrative department and the drug supervision and management department of the people's government of the municipality directly under the Central Government shall be within 30 working days from the date of receiving the application，Decision to make whether or not agreed or approved。

Article 21 of the medical institution to change the license of the "Medical Institutions Permit"，It should be changed 30 days before the permit.，In accordance with the provisions of Article 20 of these regulations, review the original audit、Application organs apply for change registration of the "Medical Institution Permit"; not approved，Do not change the license items。Original review、The approval authority shall make a decision within 15 working days from the date of receiving the application。
Added a new dosage form or change the preparation of the preparation place for medical institutions，The province of where is located、Autonomous Region、After the acceptance of the drug supervision and management department of the people's government directly under the Central Government，The change registration of the "Medical Institution Permit" in accordance with the provisions of the previous paragraph。

Article 22 The "Medical Institutional Preparation License" is valid for 5 years。Validity period expires，You need to continue to prepare the preparation，Medical institutions shall 6 months before the validity period of the permit，Apply for a renewal "Medical Institution Preparation License"。
Medical institutions Termid the preparations or close，"Medical Institutions Permits" will be sold by the original certificate agency。

Article 23 Medical Institution Preparation Preparation，It must be submitted to relevant information and samples in accordance with the regulations of the State Council's Drug Administration，Sales of the Scripture、Autonomous Region、Approval of the drug supervision and management department of the people's government directly under the Central Government，Paper to the preparation approved number，Fang can be prepared。

Twenty -four preparations prepared by medical institutions shall not sell or sell in disguise in the market，Do not publish a medical institution preparation advertisement。
Disaster situation、Epidemic Love、emergencies or clinical urgent needed and the market is not available，State Council or province、Autonomous Region、Approval of the drug supervision and management department of the people's government of the municipality directly under the Central Government，within the specified period，Preparation preparations prepared by medical institutions can be adjusted between designated medical institutions。
The adjustment of the special preparations stipulated by the drug supervision and management department of the State Council and the province、Autonomous Region、Adjustment of the preparation of medical institutions between municipalities，It must be approved by the State Council's Drug Supervision and Management Department。

Twenty -five pharmacies who review and deploy prescriptions for medical institutions must be pharmacy and technicians identified in accordance with the law。

Article 26 Medical institutions purchase medicines，must be true、Complete medicine purchase records。Drug purchase record must indicate the common name of the drug、Dosage form、Specification、batch number、Validity period、Manufacturer、Supply Unit、Number of purchases、Buy price、Purchase date and other content stipulated by the State Council's drug supervision and management department。

Article 27 The medicine provided by the medical institution to the patient shall be compatible with the diagnosis and treatment range，And the prescription deployment of the prescription of a practicing physician or a practicing assistant physician。
Purchasing and providing drugs to patients with family planning technology service institutions，The range should be consistent with the approved service scope，And the prescription deployment of the prescription of a practicing physician or a practicing assistant physician。
The outpatient department set by personal settings、Clinic and other medical institutions shall not be equipped with other medicines other than common drugs and first -aid drugs。The scope and variety of commonly used medicines and first -aid drugs，From the province where the location is、Autonomous Region、The health administrative department of the people's government of the municipality directly under the Central Government, in conjunction with the drug supervision and management department of the people's government at the same level,。

Chapter 5 Drug Management

Article 28 Drug Non -Clinical Safety Evaluation Research Institut，Drug clinical trial institutions must perform the "Specifications for Quality Management of Drug Clinical Test"。"Specifications for Quality Management of Drug Non -clinical Research"、"Regulations on the Quality Management of Drug Clinical Test" was formulated by the State Council's Drug Supervision and Administration Department of the State Council and the Health Administrative Department of the State Council。

Article 29 Drug Clinical Test、Production drugs and imported drugs，It should comply with the provisions of the Drug Management Law and these regulations，Examination and approval by the State Council's Drug Supervision and Administration Department;、Autonomous Region、The drug supervision and management department of the people's government of the municipality directly under the Central Government reviews the development and conditions of the application of drugs，Classification of the application information，and test the samples of the trial production。Specific measures are formulated by the Drug Supervision and Administration Department of the State Council。

Article 30 develops new medicines，The clinical trials need to be performed，The provisions of Article 29 of the Drug Management Law should be，Approved by the Drug Supervision and Administration Department of the State Council。
Drug Clinical Test Application is approved by the State Council's drug supervision and management department，The applicant shall choose an institution that bears the drug clinical trials in institutions with drug clinical trials qualified by drug clinical trials in accordance with the law，And the clinical trial agency reported to the State Council's Drug Supervision and Administration Department for the State Council and the State Council's Health Administrative Department for the Council。
Drug clinical trial institutions conduct drug clinical trials，The actual situation of the subject or the guardian shall be informed in advance，and obtained its written consent。

Article 31: Drugs that produce existing national standards，shall be in accordance with the provisions of the Drug Supervision and Administration Department of the State Council，Xiang Province、Autonomous Region、The Drug Supervision and Administration Department of the People's Government of the Municipality or the Drug Supervision and Administration Department of the State Council submits an application，Submit relevant technical information and provide relevant certification documents。Provincial、Autonomous Region、The drug supervision and management department of the people's government of the municipality directly under the Central Government shall review it within 30 working days from the date of acceptance of the application，After submitting an opinion, submit it to the State Council's Drug Supervision and Management Department for review，and the reporter of the review opinion at the same time。The Drug Supervision and Administration Department of the State Council is reviewed by the review，Send to the drug approval number。

Article 32 Change the development of new drugs、Production drugs and imported drugs have been approved for certification documents and the matters stated in its attachments，It shall submit supplementary applications to the Drug Supervision and Administration of the State Council;，It should be approved。Where，Not changing the inherent quality of the medicine，It should be provincial、Autonomous Region、The drug supervision and management department of the people's government of the municipality directly under the Central Government will apply for supplementary applications; province、Autonomous Region、The drug supervision and management department of the people's government of the municipality directly under the Central Government is reviewed by the audit，It should be approved，Reported to the Drug Supervision and Administration Department of the State Council for filing。Supplementary applications that do not change the inherent quality of the drug are formulated by the State Council's drug supervision and management department。

Article 33 The Drug Supervision and Administration of the State Council shall be based on the requirements of protecting public health，The monitoring period that can be established for new drugs produced by pharmaceutical manufacturers; during the monitoring period，Do not approve other enterprises to produce and import。

Article 34 The state's self -obtained and unveiled test data and other data for the production or sales of producers or sellers who obtain production or sales of new chemical ingredients permit，No one allows the unveiled experimental data and other data to make improper commercial use。
Self -drug producer or seller gets production、A licensed document of the new type of chemical ingredient drugs within 6 years，For other applicants who have obtained permits, the applicant's consent，Application for production with the previous data、Sales of new types of chemical ingredients for drug permit，Drug supervision and management department does not permit; but，Other applicants submit their own data to obtain data。
Except the following situation，Drug supervision and management department shall not disclose the data stipulated in the first paragraph of this article:
(1) Public interest needs;
(2) A measures have been taken to ensure that this type of data will not be used by commercial use。

Article 35: Apply for imported medicines，It should be a drug that obtains a listing license in the country or region;，Confirm the safety of the drug varieties by the Drug Supervision and Administration of the State Council、Effective and clinically required，It can be approved in accordance with the "Drug Management Law" and the provisions of these regulations。
Imported drugs，Application for registration shall be applied for registration in accordance with the regulations of the State Council's drug supervision and management department。Drugs produced by foreign companies obtained "Import Drug Registration Certificate"，Hong Kong, China、After the drugs produced by enterprises in Macau and Taiwan have obtained the "Medical Product Registration Certificate"，Fang can be imported。

Article 36 The medical institution stake sports betting appis in urgent need to import stake betting appa small amount of drugs，The "Medical Institutional Practice License" shall apply to the Drug Supervision and Administration Department of the State Council; after approval,，Fang can be imported。Imported medicines should be used in specific medical institutions for specific medical purposes。

Article 37 After imported drugs to the shore，Imported units shall hold the "Imported Drug Registration Certificate" or "Medical Product Registration Certificate" and the original origin of the origin.、A copy of the purchase contract、Packing list、Yunlong、Freight invoice、Report from the factory inspection、Manual and other materials，File in the drug supervision and management department where the port is located。The drug supervision and management department of the port is reviewed，The submitted materials meet the requirements，Send to "Import Drug Clearance Flies"。Imported units go through the customs declaration and release procedures from the customs with the "Import Drug Clearance Form"。
The drug supervision and management department where the port is located shall notify the drug inspection agency to conduct random inspection of imported drugs; but，Except for the situation specified in Article 41 of the Drug Management Law。

Article 38 Vaccine Products、Blood Products、The in vitro diagnostic reagent for blood sources and other biological products stipulated by the State Council's drug supervision and management department are，It should be inspected or approved in accordance with the regulations of the State Council's Drug Supervision and Administration;，Do not sell or import。

Article 39 The state encourages the cultivation of Chinese medicinal materials。Concentrated large -scale cultivation and breeding、Quality can control and meet the conditions stipulated by the State Council's drug supervision and management department，Implement approval text number management。

Article 40 The drug supervision and management department of the State Council has approved production、The medicine sold for re -evaluation，Review results according to the medicine，You can order to modify the drug manual，Pay production、Sales and use measures; medicines that endanger the health of human health for adverse reactions or other reasons，It should be revoked the document of the drug approval。

Article 41 The drug approval number issued by the Drug Supervision and Administration Department of the State Council、"Import Drug Registration Certificate"、"Medical Product Registration Certificate" is valid for 5 years。Validity period expires，You need to continue production or import，It should be applied for re -registration at 6 months before the validity period expires。When the medicine is registered，It shall submit relevant information in accordance with the regulations of the State Council's Drug Supervision and Administration。Validity period expires，No application for re -registration or review does not meet the requirements of the State Council's drug supervision and management department for registering again，Logging out its drug approval number、"Import Drug Registration Certificate" or "Medical Product Registration Certificate"。
The re -registration of the drug approval number is registered by the province、Autonomous Region、Approval of the Drug Supervision and Administration of the People's Government of the Municipality directly under the Central Government，Reported to the Drug Supervision and Administration Department of the State Council for record; "Imported Drug Registration Certificate"、The re -registration of "Medical Product Registration Certificate" is approved by the State Council's Drug Supervision and Administration Department。

Article 42 Non -drug must not be packaged、Tag、The instructions and related publicity materials contain prevention、Treatment、Diagnosis of relevant content of human diseases and other related content; but，Law、Except for other regulations on administrative regulations。

Chapter 6 Management of Pharmaceutical Packaging

Article 43 Direct contact drugs and containers used by drug manufacturers，It must meet the medicinal requirements and guarantee human health、Standards for safety，and approved by the State Council's Drug Supervision and Administration Department。
Administrative measures for packaging materials and containers of direct contact with drugs、Product directory and medicinal requirements and standards，It was formulated and announced by the Organization of the Drug Supervision and Administration Department of the State Council。

Article 44 The production of Chinese medicine drinks，Packaged materials and containers that are compatible with the nature of the drug should be selected; the packaging of traditional Chinese medicines that do not meet the prescribed Chinese medicine，Do not sell。Chinese medicine drinking tablets must be printed or labeled with labels。
The label of Chinese medicine drinks must be indicated、Specification、Place of origin、Production Enterprise、Product batch number、Production date，Traditional Chinese medicine drinking tablets implemented by the approval number must also indicate the drug approval number。

Article 45 Pharmaceutical Packaging、Tag、The instructions must be printed in accordance with Article 54 of the Drug Administration Law and the provisions of the State Council's drug supervision and management department。
The name of the drug product should comply with the regulations of the State Council's drug supervision and management department。

Article 46 Direct contact medicines and containers used in the preparation of medical institutions、The label and instructions of the preparation shall comply with Chapter 6 of the Drug Management Law and the relevant provisions of these regulations，and province、Autonomous Region、Approval of the drug supervision and management department of the people's government directly under the Central Government。

Chapter 7 Drug Price and Advertising Management

Article 47 The competent government department of the government shall implement the drug price monitoring when the price of drug price is implemented in accordance with Article 28 of the Price Law，For master、Analysis of changes and trends of drug prices，You can specify some pharmaceutical manufacturers、Drug operating enterprises and medical institutions as price monitoring designated units; fixed -point units should be given cooperation、Support，Provide relevant information and information truthfully。

Article 48 Release Drug Advertising，The province of the drug manufacturer is located、Autonomous Region、The drug supervision and management department of the people's government of the municipality directly under the Central Government submits relevant materials。Provincial、Autonomous Region、The Drug Supervision and Administration Department of the People's Government of the Municipality directly under the Central Government shall make a decision to issue a drug advertising approval number within 10 working days from the date of receiving the relevant materials;，It should be submitted to the Drug Supervision and Administration Department of the State Council for record。Specific measures are formulated by the Drug Supervision and Administration Department of the State Council。
Published imported drug advertisements，The province of the imported drug agency in accordance with the provisions、Autonomous Region、Application number of drug advertising approval texts for the people's government of the People's Government of the Municipality directly under the Central Government。
Provincial provinces outside the pharmaceutical manufacturer and the place where the imported drug agency is located、Autonomous Region、Pharmaceutical advertisements published in municipality，Enterprises published by advertising shall be published before the release of the province、Autonomous Region、Drug supervision and management department of the people's government of the Municipality directly under the Central Government。Provincial province with filing、Autonomous Region、The drug supervision and management department of the people's government of the municipality directly under the Central Government found that the content，It should be handled by the original issuance department for treatment。

Article 49: The State Council or the province、Autonomous Region、Drug supervision and management department of the people's government of the municipality directly under the Central Government decide，Order to suspend production、Drugs sold and used，During the suspension period, it must not be published in this variety of drug advertisements;，Must stop immediately。

Article 50 without province、Autonomous Region、Pharmaceutical advertisements approved by the drug supervision and management department of the people's government directly under the Central Government，Use forgery、Use for use、Advertisement of the Effective Drug Advertising Approval Number，Or the advertisement of the drug advertising approval number due to other advertising illegal activities，Enterprises published advertising、Advertising operator、Advertising publishers must immediately stop the release of the drug advertisement。
Play drug ads illegally，The serious plot，Provincial、Autonomous Region、The drug supervision and management department of the people's government of the municipality may be announced。

Chapter 8 Drug Supervision

Article 51 Drug Supervision and Administration (including the drug supervision and management agency established by the drug supervision and management department of the Provincial People's Government，Same below) The development of medicines in accordance with the law、Production、Business、Using implementation supervision and inspection。

Article 52 Drug sampling must be implemented by more than two drug supervision and inspectors，and sample in accordance with the regulations of the State Council's Drug Supervision and Administration;，Do not refuse。
There is no legitimate reason for the sampling unit of the drug，Refusal the spot checking inspection，The Drug Supervision and Administration Department of the State Council and the province where the sampling inspection unit is located、Autonomous Region、The drug supervision and management department of the people's government of the municipality may announce the suspension of the drug listing and use of drugs that the unit refuses to sampling.。

Article 53 Passenger doped、Drugs doped suspected，When the inspection method and inspection items cannot be tested in the national pharmaceutical standards，Drug inspection agencies can supplement the inspection method and inspection items for drug testing; after approval by the State Council's drug supervision and management department，The test results obtained by using the supplementary inspection method and the inspection items，It can be used as the basis for the quality of drug supervision and management department。

Article 54 of the State Council and Provincial Council、Autonomous Region、The pharmaceutical supervision and management department of the people's government of the municipality directly under the Central Government shall be based on the results of the drug quality spot check and inspection.，Regularly published drug quality announcements。Drug Quality Announcement shall include the name of the drug test、Source of inspection products、Production Enterprise、Production batch number、Drug specifications、Inspection Agency、Inspection basis、Test results、Unqualified items, etc.。Improper announcement of the quality of the drug，The publishing department shall confirm within 5 days from the date of improper announcement，Correct it within the scope of the original announcement。
The parties have objections to the test results of the drug inspection institution，Apply for re -inspection，It shall submit a written application to the drug inspection institution responsible for re -inspection、Original Drug Inspection Report。The samples of the re -inspection are extracted from stake betting appthe original stake sports betting apppharmaceutical inspection agency。

55 The drug supervision and administration department takes evidence to prove that there is evidence to prove that the drugs that may endanger human health and their relevant evidence materials、The administrative compulsory measures detained，It should make a decision on whether to file a case within 7 days from the date of adopting administrative compulsory measures;，It shall make a decision to make a case within 15 days from the date of the inspection report;，It should be relieved of administrative compulsory measures; it is necessary to suspend sales and use，It should be by the State Council or the province、Autonomous Region、The drug supervision and management department of the people's government of the municipality directly under the Central Government makes a decision。

Fifty -six drug spot checks，Do not charge any fee。
The parties have objections to the results of the drug test，Apply for re -inspection，It should be according to the relevant departments of the State Council or the province、Autonomous Region、Regulations of the relevant departments of the people's government of the municipality directly under the Central Government，Pre -paid drug inspection costs to re -inspection institutions。The conclusion of the re -inspection is inconsistent with the original inspection conclusion，Rehabilitation inspection costs shall be borne by stake betting appthe original stake sports betting apppharmaceutical inspection agency。

Article 57 issued a certificate in accordance with the "Drug Administration Law" and the provisions、Register for drugs、Pharmaceutical certification and implementation of drug approval tests and its mandatory test，You can charge fees。Specific charging standards are by the financial department of the State Council、Formulated by the competent price department of the State Council。

Chapter 9 Legal Responsibility

58 drug production enterprises、Drug operating enterprises have one of the following situations，Punishment shall be punished by the drug supervision and management department in accordance with the provisions of Article 79 of the Drug Administration Law:
(1) Opening a drug manufacturer、Pharmaceutical manufacturers new drug production workshops、New production dosage form，During the period stipulated by the State Council ’s drug supervision and management department, it failed to pass the“ Quality Management Specifications for Drug Production ”for certification，Drug production is still performed;
(2) Opening a drug business enterprise，During the period stipulated by the State Council ’s drug supervision and management department, it failed to pass the“ Drug Operation Quality Management Specification ”for certification，Still in drug management。

Article 59 The provisions of Article 13 of the Drug Administration Law，Entrusted or accepted the production of drugs，Both the attorney and the trustee shall be punished in accordance with Article 74 of the Drug Management Law。

Article 60 without approval，Selling drugs to sell drugs in the urban and rural market trade market or the drug sold in the urban and rural market trade market exceeds the scope of drugs that are approved for operation，Punishment in accordance with Article 73 of the Drug Management Law。

Article 61 without approval，Medical institutions use the preparations prepared by other medical institutions，Punishment is given in accordance with Article 80 of the Drug Administration Law。

Article 62 of the outpatient department of personal settings、Clinic and other medical institutions to patients provided to patients exceed the scope and variety of species and varieties，Punishment in accordance with Article 73 of the Drug Management Law。

Article 63 Medical institutions use fake medicines、Bad drugs，According to Article 74 of the Drug Management Law、Article 75 provisions are given punishment。

Article 64 The provisions of Article 29 of the Drug Management Law，Performing clinical trials，Institutions that bear the clinical trials of drugs，Punishment is given in accordance with the provisions of Article 79 of the Drug Management Law。

Article 65 Drug applicants when applying for clinical trials，Submit false development method、Quality Standards、Pharmacology and toxicological test results and other relevant information and samples，The Drug Supervision and Administration Department of the State Council will not be approved by the clinical trials of the application for the drug，Alert to drug applicants;，No acceptance of the clinical trial application of the drug application for the application of the drug will not be accepted within 3 years。

Article 66: Chinese medicine tablets without national drug standards，Not province、Autonomous Region、The specifications formulated by the drug supervision and management department of the people's government of the municipality directly under the Central Government; medical institutions do not follow the province、Autonomous Region、The standard preparation preparations approved by the drug supervision and management department of the people's government of the municipality，Punishment in accordance with Article 75 of the Drug Administration Law。

Article 67 The drug supervision and management department and their staff violate the regulations，Leak producer、Seller is to get production、Unveiled test data or other data submitted by selling new types of chemical ingredients permit，The loss caused by the applicant，The drug supervision and management department shall bear the liability for compensation according to law; after the compensation of the drug supervision and management department is compensated，Staff members who are ordered to be intentional or have major faults shall bear some or all compensation fees，and give administrative sanctions to the person directly responsible。

Article 68 Drug Production Enterprise、Production of pharmaceutical business enterprises、Pharmaceuticals operated by medicine and medical institutions，Its packaging、Tag、The manual violates the "Drug Management Law" and the provisions of these regulations，Punishment in accordance with Article 86 of the Drug Administration Law。

Article 69 Pharmaceutical Production Enterprise、Drug business enterprises and medical institutions change drug production and operation permits，It should go through the change of registration procedures and not handled it，Warning from the original certificate department，Order the registration procedures for replacement within a time limit;，Announce its "Drug Production License"、"Drug Business License" and "Medical Institutional Preparation License" are invalid; still engaged in drug production and operation activities，Punishment in accordance with Article 73 of the Drug Management Law。

Article 70 of the drug advertising content approved by the scriptures，The drug supervision and management department ordered the advertiser to immediately stop the release of the drug advertisement，And the original approved drug supervision and management department shall be punished in accordance with Article 92 of the Drug Management Law。
After the drug supervision and management department revokes the drug advertising approval number，It should be notified of the advertising supervision and management authority within 5 working days from the date of the decision to make an administrative processing decision。Advertising supervision and management organs shall be within 15 working days from the date of receiving the notice of the drug supervision and management department，Make administrative treatment decisions in accordance with the relevant provisions of the "Advertising Law of the People's Republic of China"。

71st enterprise published a pharmaceutical advertise、Autonomous Region、Pharmaceutical advertisements released by municipality，No province for release in accordance with regulations、Autonomous Region、The Pharmaceutical Supervision and Management Department of the People's Government of the Municipality directly under the Central Government，The pharmaceutical supervision and management department released by the place is ordered to make corrections within a time limit;，Stop the advertising release activity of the drug variety in the place of release。

Article 72 without province、Autonomous Region、Approval of the drug supervision and management department of the people's government directly under the Central Government，Posted by Pharmaceutical Advertising，After discovery of the drug supervision and management department，It shall notify the advertising supervision and management department to investigate and deal with it in accordance with the law。

Article 73 The provisions that violate the Drug Management Law and these Regulations，One of the following behaviors，The punishment of the punishment of the Drug Supervision and Administration in the "Drug Management Law" and the regulations stipulated in these regulations:
(1) Anesthesia drugs、Psychiatric drugs、Medical toxic drugs、Radial drugs pretend to be other medicines，or impersonate the above medicines with other medicines;
(2) Production、Sales for pregnant women、Infants and children are fake medicines that are mainly used by objects、Inferior medicine;
Bio products sold、Bio products sold、Blood products are fake medicine、Inferior medicine;
(4) Production、Sales、Use fake medicine、Infinite medicine，What causes the consequences of injury;
(5) Production、Sales、Use fake medicine、Infinite medicine，After processing, the offender is handled;
(6) Rejects、Escape Supervision and Inspection，or forgery、Destruction、Hidden relevant evidence materials，or use sealing without authorization、Sealing items。

Article 74 of the Drug Supervision and Administration Department's Division Institution，Have the right to make the "Drug Management Law" and the warning stipulated in these regulations、Power of fines、Conflict illegal production、Drugs sold and administrative penalties for illegal income。

Article 75 Drug Operation Enterprise、Medical institutions have not violated the relevant provisions of the Drug Management Law and these regulations，and have sufficient evidence to prove that the medicine it sells or use is a fake medicine、Bad drugs，It should be confiscated of the fake drugs that they sell or use、Inferior drugs and illegal income; but，can be eliminated by other administrative penalties。

Article 76 Items confiscated in accordance with the "Drug Management Law" and the provisions of these regulations，Supervision and treatment by the drug supervision and management department in accordance with regulations。

Chapter 10 Attachment

Article 77 The meaning of the following terms in these regulations:
Pharmaceutical qualification certificate and other logos，refers to the certification document of drug production、Drug Inspection Report、Packaging of Drugs、Tags and instructions。
New medicine，refers to a medicine that has not been listed in China。
Prescription medicine，refers to the prescription of the practice physician and a practicing assistant physician to buy、Drugs prepared and used。
Non -prescription medicine，refers to published by the Drug Supervision and Administration Department of the State Council，Do not need to be prescribed by a practicing physician and practicing assistant physician，Consumers can judge themselves、Pharmaceuticals purchased and used。
Preparation of medical institutions，refers to the preparation of medical institutions according to the clinical needs of the unit、Self -use fixed prescription preparation。
Drug certification，refers to the development of the drug supervision and management department for the development of drugs、Production、Business、Use the unit to implement the corresponding quality management specifications for inspection、Evaluation and decide whether to issue the corresponding certification process。
Drug management method，refers to drug wholesale and pharmaceutical retail。
Drug business scope，refers。
Pharmaceutical Wholesale Enterprise，refers、Drug business enterprise、Drug business enterprises of medical institutions。
Pharmaceutical retail enterprises，refers。

Article 78 "Drug Management Law" Article 41 "Pharmaceuticals sold in China for the first time"，refers to the first drug sold by domestic or foreign pharmaceutical manufacturers，Including the same variety produced by different pharmaceutical manufacturers。

Article 79 "Drug Administration Law", paragraph 2) "Production enterprise for prohibiting drugs from drugs、The person in charge of the medical institution of the medical institution that uses the business in any name、Drug purchaser、"Doctors and other relevant personnel such as property or other interests" "property or other interests"，refers to the production enterprise of drugs、Operating enterprise or the person in charge of its agent to the medical institution、Drug purchaser、The purpose provided by relevant personnel such as physicians and other personnel is to affect their drug procurement or the unproper interest of drug prescription behaviors。

Article 80 These Regulations will be implemented from September 15, 2002。