Implementing Regulations of the Drug Administration Law of the People's Republic of China (Revised in 2016)

Order of the State Council No.666

February 6, 2016

(Promulgated by the Order of the State Council of the People's Republic of China No.360 on August 4, 2002; and revised in accordance with the Decision of the State Council on Revising Certain Administrative Regulations by the Order of the State Council of the People's Republic of China No.666 on February 6, 2016)

Chapter I General Provisions

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

Article 2 The pharmaceutical regulatory department under the State Council shall establish state pharmaceutical inspection institute.
The pharmaceutical regulatory department of the people's government of a province, autonomous region or municipality directly under the Central Government may establish pharmaceutical inspection institute within its respective administrative area. The plan for the establishment of local pharmaceutical inspection institutes shall be proposed by the pharmaceutical regulatory department of the people's government of the province, autonomous region and municipality directly under the Central Government and submitted to the people's government of the province, autonomous region and municipality directly under the Central Government for approval.
The pharmaceutical regulatory department under the State Council and the pharmaceutical regulatory department of the people's government of a province, autonomous region or municipality directly under the Central Government may, when necessary, designate inspection institute fulfilling the requirements for pharmaceutical inspection to undertake the pharmaceutical inspection.

Chapter II Administration of the Pharmaceutical Producing enterprises

Article 3 To establish a drug manufacturer, the applicant shall submit an application to the drug regulatory department of the people's government of the province, autonomous region or municipality directly under central government where the manufacturer is to be located. The drug regulatory department of the people's government of the province, autonomous region or municipality directly under central government shall, within 30 working days from the date it receives the application, arrange an acceptance inspection according to the requirements for the establishment of such manufacturers in Article 8 of the Drug Administration Law, and issue a Drug Manufacturing Certificate to the applicant if the inspection is passed.

Article 4 Any pharmaceutical manufacturer that intends to alter the approved items in the Drug Manufacturing Certificate shall, 30 days prior to the alteration of any approved items, apply to the original certificate-issuing authority for the registration of alteration; no approved items shall be altered without approval. The original certificate-issuing authority shall make a decision within 15 working days after it receives the application.

Article 5 The pharmaceutical regulatory department of the people's government at or above the provincial level shall organize the inspections of drug manufacturing enterprises in accordance with the Good Manufacturing Practice for Pharmaceutical Products (GMP) and the measures and schedule for the implementation of the GMP formulated by the pharmaceutical regulatory department under the State Council, and issue a certificate to the manufacturer that complies with the GMP. For the manufacturer producing injections or radioactive pharmaceuticals and for those producing biological products specified by the pharmaceutical regulatory department under the State Council, the inspection of which shall be conducted by the pharmaceutical regulatory department under the State Council.
The format of GMP certificate shall be uniformly provided for by the pharmaceutical regulatory department under the State Council.

Article 6 Any newly-established drug manufacturer or manufacturer with newly -built pharmaceutical manufacturing workshops or newly-added dosage forms for production shall, within 30 days after it obtains the approval documents for drug manufacturing or after its formal production is approved, apply to the pharmaceutical regulatory department for GMP certification as required. The pharmaceutical regulatory department accepting the application shall, within six months after it receives the application, organize inspections as to the compliance with the GMP requirements by the applying manufacturer. A certificate shall be issued to the manufacturer if the inspection is passed.

Article 7 The pharmaceutical regulatory department under the State Council shall set up a database of GMP inspectors. A GMP inspector shall be qualified as required by the pharmaceutical regulatory department under the State Council. A GMP inspection shall be conducted by a team of inspectors randomly selected from the database of GMP inspectors according to the provisions of the pharmaceutical regulatory department under the State Council.

Article 8 The valid term of a Drug Manufacturing Certificate is five years. To continue its pharmaceutical production, the Certificate holder shall, six months prior to the expiry date of the Certificate, apply for the renewal of the Drug Manufacturing Certificate according to the provisions of the pharmaceutical regulatory department under the State Council.
Where a pharmaceutical manufacturer terminates its pharmaceutical production or is closed down, its Pharmaceutical Manufacturing Certificate shall be withdrawn by the original certificate-issuing authority.

Article 9 The bulk pharmaceutical chemicals used by a pharmaceutical manufacturer to produce pharmaceutical products shall have a pharmaceutical approval number or an import pharmaceutical license or a pharmaceutical product license issued by the pharmaceutical regulatory department under the State Council upon examination, with the exception of Traditional Chinese medicines and the prepared slices of Traditional Chinese medicines over which no control by approval number has been carried out.

Article 10 In accordance with Article 13 of the Drug Administration Law, any pharmaceutical manufacturer being entrusted with contract production of pharmaceuticals shall have a GMP certificate corresponding to the contracted pharmaceutical.
The production of vaccines, blood products or other pharmaceuticals specified by the pharmaceutical regulatory department under the State Council shall be sub-contracted.

Chapter III Administration of Pharmaceutical Trading Enterprises

Article 11 For the establishment of a pharmaceutical wholesale enterprise, the applicant shall apply to the pharmaceutical regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government, where the planned pharmaceutical wholesale enterprise is to be located. The pharmaceutical regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government shall, within 30 working days after it receives the application, make a decision on whether to approve or disapprove the preparation and establishment of the enterprise according to the standards for establishment provided by the pharmaceutical regulatory department under the State Council. After the completion of the establishment of the planned wholesale enterprise, the applicant shall apply to the original approving department for acceptance inspection. The original approving department shall, within 30 working days after it receives the application, organize an acceptance inspection according to the requirements for the establishment of pharmaceutical trading enterprises as set forth in Article 15 of the Drug Administration Law and issue the Drug Supply Certificate to the applicant if the inspection is passed.

Article 12 For the establishment of a pharmaceutical retailer, the applicant shall submit an application to the pharmaceutical regulatory institution of the municipality divided into districts, or to the pharmaceutical regulatory institution at the county level which is directly set up by the pharmaceutical regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government, where the planned retailer is to be located. The pharmaceutical regulatory institution accepting the application shall, within 30 working days after it receives the application, make a decision on whether to approve or disapprove the establishment after the review according to the provisions of the pharmaceutical regulatory department under the State Council, taking into consideration of the number of permanent residents, territory, transportation and practical needs at the local place. After the completion of the establishment of the planned retailer, the applicant shall apply to the original approving department for acceptance inspections. The original approving department shall, within 15 working days after it receives the application, organize acceptance inspections according to the requirements for the establishment of pharmaceutical trading enterprises as set forth in Article 15 of the Drug Administration Law and issue a Drug Supply Certificate if the inspections are passed.

Article 13 The drug regulatory department of the people's government of a province, autonomous region or municipality directly under central government and the drug regulatory department at the level of a city divided into districts are responsible for the certification of drug business operators. A drug business operators shall, according to the implementing measures and schedule formulated by the drug regulatory department under the State Council, undergo the certification of Good Supply Practice for Pharmaceutical Products (GSP) organized by the drug regulatory department of the people's government of a province, autonomous region or municipality directly under central government or the drug regulatory department at the level of a city divided into districts and obtain a GSP certificate. The format of the GSP certificate shall be uniformly provided for by the drug regulatory department under the State Council.
A newly-established drug wholesaler and retailer shall, within 30 days from the date it obtain the Drug Supply Certificate, apply for the GSP certification to the drug regulatory department or agency which has issued the Drug Supply Certificate to it. The drug regulatory department or agency accepting such application shall, within three months from the date it receives the application, organize an inspection of the drug wholesaler or retailer as to the compliance with the GSP by the drug wholesaler or retailer according to provisions of the drug regulatory department under the State Council and issue a GSP certificate to the drug wholesaler or retailer if the inspection is passed.

Article 14 Database of Good Distribution Practices (GDP) for Pharmaceutical Products inspectors shall be set up by the pharmaceutical regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government. A Good Distribution Practices (GDP) for Pharmaceutical Products inspector shall be qualified as required by the pharmaceutical regulatory department under the State Council. A Good Distribution Practices (GDP) for Pharmaceutical Products inspection shall be conducted by a team of inspectors randomly selected from the said database according to the provisions of the pharmaceutical regulatory department under the State Council.

Article 15 The State adopts a classification regulatory system for prescription pharmaceuticals and non-prescription pharmaceuticals. The State subdivides non-prescription pharmaceuticals into Class A pharmaceuticals and Class B pharmaceuticals according to their level of safety.
Any pharmaceutical retailer distributing prescription pharmaceuticals or Class A non-prescription pharmaceuticals shall have licensed pharmacists or other pharmaceutical technicians whose qualifications are legally recognized. Any retailer distributing Class B non-prescription pharmaceuticals shall have pharmacy staff members who have passed the examination organized by the local pharmaceutical regulatory institution of the municipality divided into districts or by the local pharmaceutical regulatory institution at the county level which is directly set up by the pharmaceutical regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government.

Article 16 Any pharmaceutical distributor that intends to alter the approved items in the Drug Supply Certificate shall, 30 days prior to the alteration of any approved items, apply to the original certificate-issuing authority for registration of alteration; and without approval, no approved items may be altered. The original certificate-issuing authority shall make a decision within 15 working days after it receives the application.

Article 17 The valid term of a Drug Supply Certificate is five years. To continue its pharmaceutical distribution, the Certificate holder shall, at six months prior to the expiry date of the Certificate, apply for the renewal of the Drug Supply Certificate according to the provisions of the pharmaceutical regulatory department under the State Council.
Where a pharmaceutical distributor terminates its pharmaceutical distribution or is closed down, its Drug Supply Certificate shall be withdrawn by the original certificate-issuing authority.

Article 18 Where there is no pharmaceutical retailers at town or country fairs in remote areas with poor communications, the local pharmaceutical retailers may, after obtaining approval from the local pharmaceutical regulatory institution of the county (municipality) and being registered with the administrative department for industry and commerce, set up stores at the fairs to sell non-prescription pharmaceuticals within the approved scope for pharmaceutical distribution.

Article 19 Pharmaceutical producing enterprises, pharmaceutical trading enterprises and medical institutions engaged in on-line pharmaceutical transactions through Internet and the pharmaceuticals so transacted shall be in conformity with the provisions of the Drug Administration Law and these Regulations. The measures for the administration of on-line pharmaceutical distribution services shall be jointly formulated by the pharmaceutical regulatory department under the State Council and the other relevant departments under the State Council.

Chapter IV Control over Pharmaceuticals in Medical Institutions

Article 20 To establish a pharmaceutical preparation unit in a medical institution, an application shall be submitted to the local health administrative department of the people's government of the province, autonomous region or municipality directly under the Central Government, and, after being consented upon examination, be presented to the pharmaceutical regulatory department of the people's government at the same level for examination and approval. Approval shall be given to the medical institution if it passes the examination by the said pharmaceutical regulatory department and a Pharmaceutical Preparation License for Medical Institution shall be issued to it.
The health administrative department and the pharmaceutical regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government shall, within 30 working after they receive the application respectively, and make their own decisions whether or not to consent or approve the application accordingly.

Article 21 Any medical institution that intends to alter the approved items in the Pharmaceutical Preparation License for Medical Institutions shall, 30 days prior to the alteration of any approved items, apply to the original examining and approving departments for registration of alteration according to the provisions of Article 20 of these Regulations; and without approval, no approved items shall be altered. The original examining and approving departments shall make decisions within 15 working days after they receive the application respectively.
Any medical institution which intends to add new dosage forms or change dispensing sites shall, after passing the acceptance inspection conducted by the local pharmaceutical regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government, go through the registration for the alteration of the Pharmaceutical Preparation License for Medical Institutions according to the provisions of the preceding paragraph.

Article 22 The valid term of a Pharmaceutical Preparation License for Medical institutions is five years. To continue dispensing a pharmaceutical preparation, the medical institution shall, six month prior to the expiry date of the Certificate, apply for the renewal of the Pharmaceutical Preparation License for Medical Institutions according to the provisions of the pharmaceutical regulatory department under the State Council.
Where a medical institution terminates dispensing Pharmaceutical Preparations or is closed down, its Pharmaceutical Preparation License for Medical Institutions shall be withdrawn by the original certificate-issuing authority.

Article 23 To dispense a pharmaceutical preparation, the medical institution shall submit the dossier and samples according to the provisions of the pharmaceutical regulatory department under the State Council, and the pharmaceutical preparation may only be dispensed after being approved by the local pharmaceutical regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government and being issued a pharmaceutical preparation approval number.

Article 24 No pharmaceutical preparations dispensed by medical institutions shall be marketed or marketed in disguised forms, nor shall any advertisement of such pharmaceutical preparations be released.
When a major disaster, epidemic situation or any other emergency occurs, or there is an urgent need clinically but there is no supply of the needed pharmaceutical in market, the pharmaceutical preparations dispensed by a medical institution may be subject to transfer allocation and used by other designated medical institutions within a specified time limit, upon approval by the pharmaceutical regulatory department under the State Council or by the pharmaceutical regulatory department of the people's government of a province, autonomous region or municipality directly under the Central Government.
Transfer allocation and usage of special pharmaceutical preparations regulated by the pharmaceutical regulatory department under the State Council, and the transfer allocation and usage of pharmaceutical preparations dispensed by medical institutions among provinces, autonomous regions, or municipalities directly under the Central Government shall be subject to the approval by the pharmaceutical regulatory department under the State Council.

Article 25 Pharmacy personnel of medical institutions who check and dispense prescriptions shall be the pharmaceutical technicians with qualifications legally recognized.

Article 26 When purchasing pharmaceuticals, medical institutions shall keep true and complete records. The purchase records shall indicate the general name of the pharmaceutical in China, dosage form, specification, batch number, date of expiry, manufacturer, supplier, purchase volume, purchase price, date of purchase and other items specified by the pharmaceutical regulatory department under the State Council.

Article 27 Pharmaceuticals provided to patients by medical institutions shall be within the scope of diagnoses and treatments and dispensed according to the prescriptions of licensed doctors or licensed assistant doctors.
The scope of pharmaceuticals purchased and provided to patients by family planning technical service institutions shall be in conformity with the scope of services approved and the pharmaceuticals shall be dispensed according to the prescriptions of licensed doctors or licensed assistant doctors.
Out-patient departments, clinics and any other medical institutions, which are set up by individuals, shall not purchase or provide pharmaceuticals other than those commonly used and those for emergency treatment. The range and category of the pharmaceuticals commonly used and those for emergency treatment shall be determined by the local health administrative department of the people's government of the province, autonomous region, or municipality directly under the Central Government jointly with the pharmaceutical regulatory department at the same level.

Chapter V Administration of Pharmaceuticals

Article 28 Institutions for non-clinical safety evaluation and study of pharmaceuticals shall implement the Good Laboratory Practice for Non-Clinical Laboratory Studies (GLP) and institutions for pharmaceutical clinical trial shall implement the Good Clinical Practice (GCP). The GLP and GCP shall be formulated by the pharmaceutical regulatory department under the State Council through respective consultation with the science and technology administrative department under the State Council and the health administrative department under the State Council.

Article 29 Clinical trials, manufacturing or importation of pharmaceuticals shall be in conformity with the provisions of the Drug Administration Law and these Regulations, and shall be examined and approved by the pharmaceutical regulatory department under the State Council. The pharmaceutical regulatory department under the State Council may authorize the pharmaceutical regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government to conduct on-site inspection of research and development conditions of the pharmaceuticals being applied, to conduct preliminary review of the submitted dossier, and to inspect the samples. The specific measures therefore shall be formulated by the pharmaceutical regulatory department under the State Council.

Article 30 Any clinical trial to be conducted for the researching and development of a new pharmaceutical shall be subject to approval by the pharmaceutical regulatory department under the State Council in accordance with of Article 29 of the Drug Administration Law.
When an application for conducting clinical trials is approved by the pharmaceutical regulatory department under the State Council, the applicant shall select institutions for clinical trials from the lawfully certified ones to conduct the trials, and report thereof to the pharmaceutical regulatory department and health administrative department under the State Council for filing.
Prior to the pharmaceutical clinical trial, the institution conducting pharmaceutical clinical trial shall provide the subjects or their guardians with the truthful information about the trial, and obtain consent in writing.

Article 31 For the production of a pharmaceutical with national pharmaceutical standards, an application shall, in accordance with the provisions of the pharmaceutical regulatory department under the State Council, be submitted to the pharmaceutical regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government or to the pharmaceutical regulatory department under the State Council, and the relevant technical data and supporting documents shall be provided. The pharmaceutical regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government shall, within 30 working days after it receives the application, review and make comments, and report the matter to the pharmaceutical regulatory department under the State Council for examination while notifying the applicant of its comments. If all the requirements are fulfilled upon examination, a pharmaceutical approval number shall be issued by the pharmaceutical regulatory department under the State Council.

Article 32 For alteration of any items indicated in the approval documents and their attachments for new drug research and development, production or importation of drugs, a supplementary application shall be submitted to the drug regulatory department under the State Council; if all the requirements are satisfied upon the review, an approval shall be given by the drug regulatory department under the State Council. If the intrinsic quality of a drug is not changed, a supplementary application shall be summited to the drug regulatory department of the people's government of a province, autonomous region or municipality directly under central government; if all the requirements are satisfied upon review, the drug regulatory department of the people's government of the province, autonomous region or municipality directly under central government shall approve the application and file the result with the drug regulatory department under the State Council for record. The items that are contained in the supplementary application without changing the intrinsic quality of drugs shall be formulated by the drug regulatory department under the State Council.

Article 33 The pharmaceutical regulatory department under the State Council may, based on the needs for the protection of public health, set an supervision period of not more than five years for a new pharmaceutical produced by a pharmaceutical manufacturer; and no approval shall be given to any other manufacturer to produce or import the said pharmaceutical during the supervision period.

Article 34 The State protects undisclosed data of pharmaceutical study and others which are independently acquired and submitted by pharmaceutical producing enterprises or sellers to obtain production or marketing approval of the pharmaceuticals in question which contain new chemical elements. No one shall make unfair commercial use of the said data.
Within six years from the date a pharmaceutical manufacturer or seller obtains the approval documents for producing or marketing a pharmaceutical containing new chemical elements, if any other applicant uses the data mentioned in the preceding paragraph to apply for approval for production or marketing of the pharmaceutical in question without permission of the original applicant who has obtained the approval, no approval shall be given to any other applicant by the pharmaceutical regulatory department except that the data submitted are acquired independently.
No pharmaceutical regulatory department shall disclose the data set forth in the first paragraph of this Article except:
1. for the need of public interests; or
2. where measures are taken to ensure that the data are protected against unfair commercial use.

Article 35 Any pharmaceutical applied to be imported shall be the one obtained marketing authorization in the country or region of its manufacturing. A pharmaceutical without such authorization may be approved of its importation in accordance with the provisions of the Drug Administration Law and of these Regulations, provided that its safety, efficacy and clinical needs have been confirmed by the pharmaceutical regulatory department under the State Council.
For importation of a pharmaceutical, an application for registration shall be made according to provisions of the pharmaceutical regulatory department under the State Council. A pharmaceutical shall only be imported after an Import Pharmaceutical License is given if it is produced by a foreign manufacturer, or a Pharmaceutical Product License is given if it is produced by a manufacturer in Hong Kong, Macao or Taiwan of China.

Article 36 Any medical institution that urgently needs to import a small amount of pharmaceuticals shall, based on a Practicing License of Medical Institution, submit an application to the pharmaceutical regulatory department under the State Council, and the pharmaceuticals in question shall only be imported upon approval. Such imported pharmaceuticals shall only be used in the designated medical institution for the specified purpose.

Article 37 After the imported pharmaceuticals arrive at the port, the pharmaceutical importer shall file a record at the local pharmaceutical regulatory department in the place where the port is located with the Import Pharmaceutical License or Pharmaceutical Product License, the original copy of the certificate of origin, duplicate copy of the purchase contract, packing list, bill of freight, shipping invoice, factory inspection report, specification and other documents. The said pharmaceutical regulatory department shall review the documents submitted and issued a Pharmaceutical Import Note if they comply with the requirements. The pharmaceutical importer shall, with the Pharmaceutical Import Note, complete the formalities for customs declaration and clearance with the Customs.
The pharmaceutical regulatory department at where the port is located shall notify the pharmaceutical inspection institution to conduct sampling and inspection of the import pharmaceuticals on each batch basis with the exception of the circumstances set forth in Article 41 of the Drug Administration Law.

Article 38 Vaccines, blood products, diagnostic reagents in vitro for blood donor screening and other biological products regulated by the pharmaceutical regulatory department under the State Council shall be subject to inspection or examination for approval according to the provisions of the pharmaceutical regulatory department under the State Council before being marketed or imported; any product that fails the inspection or has not been approved shall not be marketed or imported.

Article 39 The State encourages the cultivation of Chinese medical herbs. Controlling through approval number shall be exercised over the Chinese medical herbs that can be cultivated or raised on a large scale and in an intensified way and whose quality can be controlled and fulfills the requirements provided by the pharmaceutical regulatory department under the State Council.

Article 40 The pharmaceutical regulatory department under the State Council shall re-evaluate the pharmaceuticals approved for production and marketing and, on the basis of the re-evaluation results, may take measures as to order the revision of insert sheet or suspension of production, marketing or use of a pharmaceutical, or withdraw the approval documents of pharmaceuticals with serious adverse reaction or harmful to human health due to other reasons.

Article 41 The valid term of a pharmaceutical approval number, Import Pharmaceutical License and Pharmaceutical Product License issued by the pharmaceutical regulatory department under the State Council is five years. To continue its pharmaceutical production or importation, the applicant shall submit a re-registration application six months prior to the expiry date. When conducting re-registration of a pharmaceutical, the applicant shall submit the relevant data according to the provisions of the pharmaceutical regulatory department under the State Council. If no application for the re-registration of a pharmaceutical is made upon expiration of the valid term, or the application fails to comply with the provisions on re-registration of the pharmaceutical regulatory department under the State Council upon examination, the pharmaceutical approval number, Import Pharmaceutical License or Pharmaceutical Product License shall be withdrawn.
An application for re-registration of a drug approval number shall be reviewed and approved by the drug regulatory department of the people's government of a province, autonomous region or municipality directly under central government, and filed for record with the drug regulatory department under the State Council for; and an application for re-registration of an Registration Certificate for Import Drug License or a Registration Certificate for Pharmaceutical Products shall be reviewed and approved by the drug regulatory department under the State Council.

Article 42 No contents involving prevention, treatment or diagnosis of human diseases shall be included in the package, label or insert sheet and the related promotional materials for promoting a non-pharmaceutical product, except otherwise provided by laws or administrative regulations.

Chapter VI Control over Pharmaceutical Packaging

Article 43 Immediate packaging materials and containers used by pharmaceutical producing enterprises shall fulfill the requirements for medicinal use and the standards for ensuring human health and safety, and be subject to registration upon approval by the pharmaceutical regulatory department under the State Council.
The pharmaceutical regulatory department under the State Council shall be responsible for the formulation and issuing the measures for the control over immediate packaging materials and containers, the product directories and the requirements and standards for medicinal use.

Article 44 Packaging materials and containers selected for the production of prepared slices of the traditional Chinese medicine shall accommodate to pharmaceutical properties. No prepared slices of a traditional Chinese medicine shall be marketed with package fails to conform to the regulations. A label shall be printed on or attached to the package of prepared slices of traditional Chinese medicine.
The label of prepared slices of traditional Chinese medicine shall indicate the name of the pharmaceutical, specifications, origin of production, manufacturer, product batch number and production date; if the said pharmaceutical is controlled by approval number, the pharmaceutical approval number shall also be indicated.

Article 45 The package, label and insert sheet of a pharmaceutical shall be printed in accordance with the provisions of Article 54 of the Drug Administration Law and those formulated by the pharmaceutical regulatory department under the State Council.
The trade name of a pharmaceutical shall conform to the provisions of the pharmaceutical regulatory department under the State Council.

Article 46 The immediate packaging materials and containers, used by medical institutions for dispensing pharmaceutical preparations, as well as the labels and insert sheets thereof, shall conform to the provisions of Chapter VI of the Drug Administration Law and the relevant provisions in these Regulations, and be subject to approval by the pharmaceutical regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government.

Chapter VII Control over Pharmaceutical Pricing and Advertising

Article 47 The competent pricing department of the government may, in practicing pharmaceutical price monitoring according to the provisions of Article 28 of the Pricing Law, appoint certain pharmaceutical manufactures, pharmaceutical trading enterprises and medical institutions as pharmaceutical price monitoring units for the purpose of understanding and analyzing the changes and trends of pharmaceutical prices; the appointed units shall provide cooperation, support and truthful information.

Article 48 To publish a pharmaceutical advertisement, the relevant materials shall be submitted to the local pharmaceutical regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government where the pharmaceutical manufacturer is located. The pharmaceutical regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government shall, within ten working days after it receives the relevant materials, make a decision upon examination on whether to issue the approval number for the pharmaceutical advertisement. Where the approval number for pharmaceutical advertisement is issued upon examination, a record shall be filed at the pharmaceutical regulatory department under the State Council concurrently. The specific measures for pharmaceutical advertisement shall be formulated by the pharmaceutical regulatory department under the State Council.
To publish an advertisement for import pharmaceutical, an application for approval number for pharmaceutical advertisement shall be submitted to the local pharmaceutical regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government where the pharmaceutical import agency is located in accordance with the provisions in the preceding paragraph of this Article.
To publish an advertisement in a province, autonomous region or municipality directly under the Central Government other than the place where the pharmaceutical manufacturer or pharmaceutical import agency is located, any enterprise publishing advertisement shall file a record in advance at the pharmaceutical regulatory department of the province, autonomous region or municipality directly under the Central Government where the advertisement is to be published. If the pharmaceutical regulatory department of the province, autonomous region or municipality directly under the Central Government accepting the record finds that the approved contents of the pharmaceutical advertisement does not conform to the provisions on the control of pharmaceutical advertisement, it shall return the matter to the original verifying and issuing department for handling.

Article 49 For a pharmaceutical with production, marketing or usage is ordered to be suspended upon decision of the pharmaceutical regulatory department under the State Council or of the pharmaceutical regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government, no advertisement for the pharmaceutical shall be published during the period of suspension; where such an advertisement is already published, the publication shall be stopped immediately.

Article 50 Any enterprise publishing advertisement, advertising agent or advertisement publisher shall immediately stop the publication of any pharmaceutical advertisement without approval from the pharmaceutical regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government, or with forged approval number for pharmaceutical advertisement , or those belongs to others, or is expired, or, with canceled approval number for pharmaceutical advertisement because of other illegal advertising activities.
Where a pharmaceutical advertisement is published in violation of law and the circumstances are serious, the pharmaceutical regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government may announce the matter to the public.

Chapter VIII Supervision of Pharmaceuticals

Article 51 The Pharmaceutical regulatory department (including the pharmaceutical regulatory institution legally established by the pharmaceutical regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government, hereinafter inclusive) shall supervise and inspect the research and development, production, distribution and use of pharmaceuticals in accordance with laws.

Article 52 Sampling of a pharmaceutical shall be conducted by two or more persons who are responsible for pharmaceutical supervision and inspection in accordance with the provisions of the pharmaceutical regulatory department under the State Council.
The party whose pharmaceutical is to be sampled shall provide samples of the pharmaceutical for inspection and shall not refuse. Where the party whose pharmaceutical is to be sampled refuses the sampling and inspection of the pharmaceutical without justifiable reasons, the pharmaceutical regulatory department under the State Council and the pharmaceutical regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government where it is located may announce a stop to marketing and using of the pharmaceutical, of which the sampling and inspection are refused.

Article 53 Where a pharmaceutical is suspected of being impure or adulterated but unable to be tested by inspection method or through the inspection items prescribed in the national pharmaceutical standards, the pharmaceutical inspection institution may conduct tests by adding inspection methods and items upon approval by the pharmaceutical regulatory department under the State Council, the inspection results obtained by using the additional inspection methods and items may be taken as the basis for certifying the quality of the pharmaceuticals.

Article 54 The pharmaceutical regulatory department under the State Council and the pharmaceutical regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government shall regularly make announcements on pharmaceutical quality according to the results of sampling and inspection. A pharmaceutical quality announcement shall include the names of the sampled pharmaceuticals, sources of the samples, the producing enterprises, batch numbers, pharmaceutical specifications, inspection institutions, pharmaceutical basis, results of inspection, and items failing to pass the test, etc. If a pharmaceutical quality announcement is improperly made, the department making the announcement shall, within 5 days from the date of recognition of the improper announcement, make a correction within the scope in which the original one is made.
Where the involved party has any objection to the results of inspection conducted by the pharmaceutical inspection institution and applies for re-inspection, it shall submit a written application and the original inspection report to the pharmaceutical inspection institution which is responsible for the re-inspection. The sample for re-inspection shall be taken from the retained sample kept by the original inspection institution.

Article 55 Where the pharmaceutical regulatory department takes administrative compulsory actions to close or seize pharmaceuticals that have been proved potentially harmful to human health and the related evidentiary materials, it shall, within seven days from the date it takes such measures, make a decision on whether or not to file a case; where it is necessary to test such pharmaceuticals, it shall, within 15 days from the date the inspection report is issued, make a decision whether or not to file a case; where the conditions for filing a case are not met, the administrative compulsory actions shall be withdrawn; where the marketing and use of such pharmaceuticals need to be suspended, a decision shall be made by the pharmaceutical regulatory department under the State Council or the pharmaceutical regulatory 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 the selective pharmaceutical sampling and inspection.
Where the involved party has any objection to the results of the inspection conducted by the pharmaceutical inspection institution and applies for re-inspection, it shall pay in advance the fees for pharmaceutical inspection to the pharmaceutical inspection institution responsible for the re-inspection according to the provisions of the pharmaceutical regulatory department under the State Council or of the pharmaceutical regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government. If the results of re-inspection are different to the original inspection results, the fees for the re-inspection shall be borne by the original inspection institution.

Article 57 Fees may be collected for certificate issuance, pharmaceutical registration, pharmaceutical certification, pharmaceutical inspection for approval and mandatory pharmaceutical inspection according to the provisions in the Drug Administration Law and in these Regulations. The specific standards for charging shall be formulated by the finance department under the State Council and the competent pricing department under the State Council.

Chapter IV Legal Liabilities

Article 58 A pharmaceutical manufacturer or distributor shall be punished by the pharmaceutical regulatory department according to the provisions of Article 79 of the Drug Administration Law under any of the following circumstances:
1. where any newly-established pharmaceutical manufacturer or any manufacturer with a newly-built workshop or with newly-added dosage forms fails in the GMP certification within the time limit prescribed by the pharmaceutical regulatory department under the State Council but is still engaged in pharmaceutical production.
2. where any newly-established pharmaceutical distributor fails in Good Distribution Practices (GDP)for Pharmaceutical Products certification within the time limit prescribed by the pharmaceutical regulatory department under the State Council but is still engaged in pharmaceutical distribution.

Article 59 Any contract giver or acceptor, in violation of the provisions of Article 13 of the Drug Administration Law, giving or accepting the contract for pharmaceutical production without authorization shall be punished in accordance with the provisions of Article 74 of the Drug Administration Law.

Article 60 Where, without approval, anyone who sets up a store to sell pharmaceuticals at the town or country fairs, or sells pharmaceuticals in a store at the fairs beyond the approved scope of pharmaceutical distribution, shall be punished according to the provisions of Article 73 of the Drug Administration Law.

Article 61 Any medical institution that uses pharmaceutical preparations dispensed by other medical institutions without approval shall be punished according to the provisions of Article 80 of the Drug Administration Law.

Article 62 Any out-patient department, clinic or any other medical institution, which is set up by individuals, if providing patients with pharmaceuticals beyond the provided scope or kinds of pharmaceuticals, shall be punished according to the provisions of Article 73 of the Drug Administration Law.

Article 63 Any medical institution that uses counterfeit and/or substandard pharmaceuticals shall be punished according to the provisions of Article 74 and/or 75 of the Drug Administration Law.

Article 64 Any institution, in violation of the provisions of Article 29 of the Drug Administration Law, conducting a pharmaceutical clinical trial without approval shall be punished according to the provisions of Article 79 of the Drug Administration Law.

Article 65 Where an applicant, in applying for conducting a pharmaceutical clinical trial, submits false data on pharmaceutical production procedures, quality specifications, or results of pharmacological and toxicological studies, etc., or submits fraud samples, the pharmaceutical regulatory department under the State Council shall disapprove the application and give a warning to the applicant; where the circumstances are serious, no application for clinical trial of the said pharmaceutical submitted by the said applicant shall be accepted within three years.

Article 66 Where anyone producing prepared slices of Chinese crude pharmaceuticals without a national pharmaceutical standard fails to comply with the processing procedures formulated by the pharmaceutical regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government, or any medical institution dispensing pharmaceutical preparations fails to comply with the standards approved by the pharmaceutical regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government, punishment shall be imposed thereupon according to the provisions of Article 75 of the Drug Administration Law.

Article 67 Where the pharmaceutical regulatory department and/or its staff members, in violation of regulations, release undisclosed experimental data or other materials submitted by a manufacturer or seller for obtaining approval of production or marketing of a pharmaceutical containing new chemical elements, thus resulting in losses to the applicant, the pharmaceutical regulatory department shall be liable for compensation in accordance with the laws. After compensating the losses, the pharmaceutical regulatory department shall order the staff members who disclose the said data in purpose or have serious negligence to partially or fully bear the compensation and shall also impose administrative sanctions on those who are directly liable therefore.

Article 68 Any pharmaceutical manufacturer or distributor producing or distributing pharmaceuticals or any medical institution dispensing pharmaceutical preparations with package, labels or inset sheets violating the provisions of the Drug Administration Law or these Regulations shall be punished according to the provisions of Article 86 of the Drug Administration Law.

Article 69 Any pharmaceutical manufacturer, distributor or medical institution altering any items licensed for manufacturing, distributing, or dispensing pharmaceuticals without completing the formalities for registration of alteration as required shall be given a warning by the original certificate-issuing department and be ordered to complete the said formalities within a time limit. Its Pharmaceutical Manufacturing Certificate, Pharmaceutical Distribution Certificate or Pharmaceutical Preparation License for Medical Institutions shall be announced as nullified if it fails to do so within the time limit, and punishment shall be given according to the provisions of Article 73 of the Drug Administration Law if it continues its production and distribution activities.

Article 70 Where the approved content of a pharmaceutical advertisement is altered without authorization, the advertiser shall be ordered by the pharmaceutical regulatory department to immediately stop publishing the said advertisement, and punishment shall be given by the original approving pharmaceutical regulatory department according to the provisions of Article 92 of the Drug Administration Law.
After the pharmaceutical regulatory department withdraws the pharmaceutical advertisement approval number, it shall notify the organ in charge of advertising supervision and control of the matter within five working days from the date the administrative decision is made. The organ in charge of advertising supervision and control shall, within 15 working days after it receives the notification from the pharmaceutical regulatory department, make an administrative decision for punishment according to the relevant provisions of the Advertising Law of the People's Republic of China.

Article 71 Where any enterprise publishes a pharmaceutical advertisement outside the province, autonomous region or municipality directly under the Central Government where the pharmaceutical manufacturer or pharmaceutical import agency is located without filing at the pharmaceutical regulatory department of the province, autonomous region or municipality directly under the Central Government where the pharmaceutical advertisement is published, the pharmaceutical regulatory department of the province, autonomous region or municipality directly under the Central Government shall order the enterprise to make a rectification within the time limit. If the enterprise fails to make any rectification within the time limit, advertising activities carried out in the place for the said pharmaceutical shall be stopped.

Article 72 Where the pharmaceutical regulatory department finds that a pharmaceutical advertisement is published without approval from the pharmaceutical regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government, the pharmaceutical regulatory department shall notify the department in charge of advertising supervision and control to investigate and handle the matter in accordance with the laws.

Article 73 Where anyone that, in violation of the provisions of the Drug Administration Law and/or these Regulations, commits any of the following acts shall be given heavier punishment by the pharmaceutical regulatory department based on the extent of punishment in the Drug Administration Law and in these Regulations:
1. passing narcotics, psychotropic substances, medicinal toxic pharmaceuticals and radioactive pharmaceuticals off as other pharmaceuticals or vice versa;
2. producing or selling counterfeit or substandard pharmaceuticals of which the main users are pregnant or parturient women, infants and children;
3. producing or selling biological and/or blood products which are defined as counterfeit or substandard pharmaceuticals;
4. producing, selling or using counterfeit or substandard pharmaceuticals, thus inducing harmful results to people;
5. producing, selling or using counterfeit or substandard pharmaceuticals again after being punished for the same conduct; or
6. refusing or evading supervision and inspection, or forging, destroying or concealing relevant evidentiary materials, or using sealed and/or seized articles without authorization.

Article 74 Branches of pharmaceutical regulatory departments shall have the authority to, according to the provisions of the Drug Administration Law or these Regulations, give administrative punishments such as warning, fine and confiscation of pharmaceuticals illegally produced or marketed and illegal gains therefore.

Article 75 Where a pharmaceutical distributor or medical institution does not violate the relevant provisions of the Drug Administration Law and/or these Regulations and has sufficient evidence to prove its unawareness that the pharmaceuticals being sold or used are counterfeit or substandard pharmaceuticals, the said pharmaceuticals and illegal gains there from shall be confiscated; however, it may be exempted from other administrative punishments.

Article 76 Articles confiscated according to the provisions of the Drug Administration Law and/or these Regulations shall be dealt with under supervision by pharmaceutical regulatory departments in accordance with the provisions.

Chapter X Supplementary Provisions

Article 77 The terms used in these Regulations are defined as follows:
Pharmaceutical qualification and other markings refer to approval documents for pharmaceutical production, pharmaceutical inspection reports, pharmaceutical packages, labels and insert sheets.
New pharmaceuticals refer to the pharmaceuticals which have not been marketed within the territory of the People's Republic of China.
Prescription pharmaceuticals refer to the pharmaceuticals that may only be purchased, dispensed or used with prescriptions from licensed doctors or licensed assistant doctors.
Non-prescription pharmaceuticals refer to the pharmaceuticals announced by the pharmaceutical regulatory department under the State Council which can be purchased or used by consumers upon their own judgment without prescriptions from licensed doctors or licensed assistant doctors.
Pharmaceutical preparations in medical institutions refer to pharmaceutical preparations based on fixed prescriptions which have been dispensed upon approval from medical institutions according to their own clinical needs for their own use.
Pharmaceutical certification refers to the process through which the pharmaceutical regulatory department inspects and evaluates the units engaging in research and development, production, distribution or use of pharmaceuticals as to their compliance with corresponding requirements, and decides on whether to issue the corresponding certificates.
Pharmaceutical distribution refers to pharmaceutical wholesale and/or retail.
Scope for pharmaceutical distribution refers to the category of pharmaceuticals examined and approved for distribution by the pharmaceutical regulatory department.
Pharmaceutical wholesalers refer to the pharmaceutical trading enterprises who sell the purchased pharmaceuticals to pharmaceutical producing enterprises, pharmaceutical trading enterprises or medical institutions.
Pharmaceutical retailers refer to the pharmaceutical trading enterprises who sell the purchased pharmaceuticals to consumers directly.

Article 78 The term "pharmaceuticals to be marketed in China for the first time" used in Article 41 of the Drug Administration Law refers to the pharmaceuticals that are marketed for the first time in China by domestic or foreign pharmaceutical producing enterprises, including the same product manufactured by different pharmaceutical producing enterprises.

Article 79 In the second paragraph of Article 59 of the Drug Administration Law, "pharmaceutical producing enterprises, pharmaceutical trading enterprises or their agents are prohibited from offering, under any pretence, money or things of value or other benefits to leading members, pharmaceutical purchasers, physicians, or other related persons of the medical institutions where their pharmaceuticals are used", the term "property or other benefits" refer to the illegitimate benefits provided by pharmaceutical producing enterprises, pharmaceutical trading enterprises or their agents to the leading members, pharmaceutical purchasers, physicians, or other related persons of the medical institutions for the purpose of influencing their actions in purchasing or prescribing pharmaceuticals.

Article 80 These Regulations shall come into effect as of September 15, 2002.