Decree of the State Council of the People’s Republic of China

No. 360

The Regulations for Implementation of the Drug Administration Law of the People’s Republic of China are hereby promulgated and shall go into effect as of September 15, 2002.

Premier: Zhu Rongji
August 4, 2002

Regulations for Implementation of the Drug Administration Law of the People’s Republic of China

Chapter I
General Provisions

Article 1 The 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 drug regulatory department under the State Council shall establish a national drug  testing institute.

The drug regulatory department of the people’s government of the province, autonomous region or municipality directly under the Central Government may establish drug testing institutes within its respective administrative area. The plan for the establishment of local drug testing institutes shall be proposed by the drug 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 drug regulatory department under the State Council and the drug regulatory department of the people’s government of the province, autonomous region or municipality directly under the Central Government may, when necessary, designate any testing institute fulfilling the requirements for drug testing to undertake drug testing.

Chapter II
Control over Drug Manufacturers

Article 3 A Drug Manufacturing Certificate shall be acquired for establishment of a drug manufacturer according to the following procedures:

(1) 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 the Central Government, where the manufacturing site is to be located. The drug regulatory department of the people’s government of the province, autonomous region or municipality directly under the Central Government shall, within 30 working days from the date it receives the application, make a review according to the pharmaceutical industry development programs and policies issued by the State and make a decision on approval or disapproval.

(2) After completion of establishment of the planned manufacturer, the applicant shall apply to the original approving department for acceptance inspection. The original approving department 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 set forth in Article 8 of the Drug Administration Law; a Drug Manufacturing Certificate shall be issued to the applicant if the inspection is passed. The applicant shall, by holding the Drug Manufacturing Certificate, register with the administrative department for industry and commerce in accordance with law.

Article 4 Any drug manufacturer that intends to alter the approved items in the Drug Manufacturing Certificate shall, 30 days prior to alteration of any approved items, apply to the original certificate-issuing authority for registration of alteration; no approved items may be altered without approval. The original certificate-issuing authority shall make a decision within 15 working days from the date it receives the application. The application shall, by holding the Drug Manufacturing Certificate with altered items, register the alteration with the administrative department for industry and commerce in accordance with law.

Article 5 The drug regulatory department of the people’s government at or above the provincial level shall organize inspections of drug manufacturers in accordance with the Good Manufacturing Practice for Pharmaceutical Products (GMP) and the measures and schedule for implementing the GMP formulated by the drug 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 that producing biological products specified by the drug regulatory department under the State Council, the inspection of which shall be conducted by the drug regulatory department under the State Council. The format of GMP certificate shall be uniformly provided for by the drug regulatory department under the State Council.

Article 6 Any newly-established drug manufacturer or manufacturer with newly –built drug manufacturing workshops or newly-added dosage forms for production shall, within 30 days from the date it obtains the approval documents for manufacturing drug or from the date its formal production is approved, apply to the drug regulatory department for GMP certification as required. The drug regulatory department accepting the application shall, within six months from the date 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 drug regulatory department under the State Council shall set up a database of GMP inspectors. A GMP inspector shall be qualified as required by the drug 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 drug regulatory department under the State Council.

Article 8 The valid term of a Drug Manufacturing Certificate is five years. To continue its drug 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 drug regulatory department under the State Council.

Where a drug manufacturer terminates its drug production or is closed down, its Drug Manufacturing Certificate shall be withdrawn by the original certificate-issuing authority.

Article 9 Any drug substance used by a drug manufacturer to produce drug products shall have a drug approval number or an import drug license or a pharmaceutical product license issued by the drug regulatory department under the State Council upon examination, with the exception of Chinese crude drugs and the prepared slices of Chinese crude drugs over which no control by approval number is exercised.

Article 10 In accordance with the provisions in Article 13 of the Drug Administration Law, any drug manufacturer being entrusted with contract production of the drug shall have a GMP certificate corresponding to the contracted drug.

No vaccines, blood products or other drugs specified by the drug regulatory department under the State Council may be contracted for production.

Chapter III
Control over Drug Distributors

Article 11 For establishment of a drug wholesaler, 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 the Central Government, where the planned drug wholesaler is to be located. The drug regulatory department of the people’s government of the province, autonomous region or municipality directly under the Central Government shall, within 30 working days from the date it receives the application, make a decision on approval or disapproval according to the standards for establishment set forth by the drug regulatory department under the State Council. After completion of establishment of the planned wholesaler, the applicant shall apply to the original approving department for acceptance inspection. The original approving department shall, within 30 working days from the date it receives the application, organize an acceptance inspection according to the requirements for establishment of drug distributors set forth in Article 15 or the Drug Administration Law and issue the Drug Supply Certificate to the applicant if the inspection is passed. The applicant shall, with the Certificate, register with the administrative department for industry and commerce in accordance with law.

Article 12 For establishment of a drug retailer, the applicant shall submit an application to the drug regulatory institution of the municipality divided into districts, or to the drug regulatory institution at the county level which is directly set up by the drug 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 drug regulatory institution accepting the application shall, within 30 working days from the date it receives the application, make a decision on approval or disapproval after the review according to the provisions of the drug regulatory department under the State Council, taking into consideration the number of permanent residents, territory, transportation and practical needs in the place. After completion of 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 from the date it receives the application, organize acceptance inspections according to the requirements for establishment of drug distributors set forth in Article 15 of the Drug Administration Law and issue a Drug Supply Certificate if inspections are passed. The applicant shall, with the Certificate, register with the administrative department for industry and commerce in accordance with law.

Article 13 The drug regulatory department of the people’s government of the province, autonomous region or municipality directly under the Central Government shall be responsible for the certification of drug distributors. A drug distributor shall, according to the implementing measures and schedule formulated by the drug regulatory department under the State Council, undergo the Good Supply Practice for Pharmaceutical Products (GSP) inspections organized by the local drug regulatory department of the people’s government of the province, autonomous region or municipality directly under the Central Government and obtain a GSP certificate. The format of GSP certificate shall be uniformly provided for by the drug regulatory department under the State Council.

Any newly-established drug wholesaler or retailer shall, within 30 days from the date it obtains the Drug Supply Certificate, apply for the GSP certification to the drug regulatory department or institution which has issued it the Drug Supply Certificate. The drug regulatory institution accepting the drug retailer’s application for certification shall, within seven working days from the date it receives the application, transfer the application to the drug regulatory department of the people’s government of the province, autonomous region or municipality directly under the Central Government, which is responsible for organizing inspections of drug distributors. The drug regulatory department of the people’s government of the province, autonomous region or municipality directly under the Central government shall, within three months from the date it receives the application, organize inspections of the drug wholesaler or retailer as to its compliance with the GSP according to the provisions of the drug regulatory department under the State Council and issue a GSP certificate to the drug wholesaler or retailer passing the inspections.

Article 14 A database of GSP inspectors shall be set up by the drug regulatory department of the people’s government of the province, autonomous region or municipality directly under the Central Government. A GSP inspector shall be qualified as required by the drug regulatory department under the State Council. A GSP inspection shall be conducted by a team of inspectors randomly selected from the said database according to the provisions of the drug regulatory department under the State Council.

Article 15 The State adopts a classification system for prescription drugs and non-prescription drugs. The State subdivides non-prescription drugs into Class A drugs and Class B drugs according to the level of safety.

Any drug retailer distributing prescription drugs or Class A non-prescription drugs shall have licensed pharmacists or other pharmaceutical technicians whose qualifications are legally recognized. Any retailer distributing Class B non-prescription drugs shall have pharmacy staff members who have passed the examination organized by the local drug regulatory institution of the municipality divided into districts or by the local drug regulatory institution at the county level which is directly set up by the drug regulatory department of the people’s government of the province, autonomous region or municipality directly under the Central Government.

Article 16 Any drug 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; no approved items may be altered without approval. The original certificate-issuing authority shall make a decision within 15 working days from the date it receives the application. The application shall, by holding the Drug Supply Certificate with the altered items, register the alteration with the administrative department for industry and commerce in accordance with law.

Article 17 The valid term of a Drug Supply Certificate is five years. To continue its drug distribution, the Certificate holder shall, 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 drug regulatory department under the State Council.

Where a drug distributor terminates its drug distribution or is closed down, its Drug Supply Certificate shall be withdrawn by the original certificate-issuing authority.

Article 18 Where there is no drug retailers at town or country fairs in remote areas with poor communications, the local drug retailers may, after obtaining approval from the local drug 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 drugs within the approved scope for drug distribution.

Article 19 Drug manufacturers, drug distributors and medical institutions engaged in on-line drug transactions through Internet and the drugs so transacted shall be in conformity with the provisions in the Drug Administration Law and in the Regulations. The measures for administration of on-line drug distribution services shall be formulated by the drug regulatory department under the State Council jointly with 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 drug regulatory department of the people’s government at the same level for review and approval. Approval shall be given to the medical institution if it passes the review by the said drug regulatory department and a Pharmaceutical Preparation Certificate for Medical Institution shall be issued to it.

The health administrative department and the drug regulatory department of the people’s government of the province, autonomous region or municipality directly under the Central Government shall, within 30 working days from the dates they receive the application respectively, 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 Certificate for Medical Institution 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 in Article 20 of the Regulations; no approved items may be altered without approval. The original examining and approving departments shall make their own decisions within 15 working days from the dates 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 by the local drug regulatory department of the people’s government of the province, autonomous region or municipality directly under the Central Government, go through the registration of alteration of the Pharmaceutical Preparation Certificate for Medical Institution according to the provisions in the preceding paragraph.

Article 22 The valid term of a Pharmaceutical Preparation Certificate for Medical institution 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 Certificate for Medical Institution according to the provisions of the drug regulatory department under the State Council.

Where a medical institution terminates dispensing Pharmaceutical Preparations or is closed down, its Pharmaceutical Preparation Certificate for Medical Institution 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 drug regulatory department under the State Council, and the pharmaceutical preparation may only be dispensed after being approved by the local drug 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 may be marketed or marketed in disguised forms, nor may 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 no supply of the needed drug in market, the pharmaceutical preparations dispensed by a medical institution may be subject to transfer allocation and use by other designated medical institutions within a specified time limit, upon approval by the drug regulatory department under the State Council or by the drug regulatory department of the people’s government of a province, autonomous region or municipality directly under the Central Government.

Transfer allocation and use of special pharmaceutical preparations regulated by the drug regulatory department under the State Council, and the transfer allocation and use 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 drug regulatory department under the State Council.

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

Article 26 When purchasing drugs, medical institutions shall keep the authentic and complete records. In purchase records shall be indicted the adopted name of the drug in China, dosage form, strength, batch number, date of expiry, manufacturer, supplier, purchase volume, purchase price, date of purchase and other items specified by the drug regulatory department under the State Council.

Article 27 Drugs 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 drugs purchased and provided to patients by family planning technical service institutions shall be in conformity with the scope of services approved and the drugs 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, may not purchase or provide drugs other than those commonly used and those for emergency treatment. The range and category of the drugs 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 drug regulatory department at the same level.

Chapter V
Control over Drugs

Article 28 Institutions for non-clinical safety evaluation and study of drugs shall implement the Good Laboratory Practice for Non-Clinical Laboratory Studies (GLP) and institutions for drug clinical trial shall implement the Good Clinical Practice (GCP). The GLP and GCP shall be formulated by the drug 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 drugs shall be in conformity with the provisions in the Drug Administration Law and in the Regulations, and shall be reviewed and approved by the drug regulatory department under the State Council. The drug regulatory department under the State Council may authorize the drug regulatory department of the people’s government of the province, autonomous region or municipality directly under the Central Government to conduct site inspection of research and development conditions of the drugs being applied, to conduct preliminary review of the submitted dossier, and to test the pilot samples. The specific measures therefore shall be formulated by the drug regulatory department under the State Council.

Article 30 Any clinical trial to be conducted for research and development of a new drug shall be subject to the approval by the drug regulatory department under the State Council in accordance with the provisions in Article 29 of the Drug Administration Law.

When an application for conducting clinical trials is approved by the drug regulatory department under the State Council, the applicant shall select institutions for clinical trials from the lawfully certified ones to conduct the trials, and make a report thereof to the drug regulatory department and health administrative department under the State Council for the record.

Prior to the drug clinical trial, the institution for drug clinical trial shall provide the subjects or their guardians with the truthful information on the trial, and obtain a written informed consent

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

Article 32 Where a drug is produced according to an interim standard, an application shall be submitted for formalization of the standard three months prior to the expiry date of the interim standard according to the provisions of the drug regulatory department under the State Council; the drug regulatory department under the State Council shall, within 12 months from the expiry date of the interim standard, review and approve the interim standard as formal one if it fulfills the requirements for the formalization set forth by the drug regulatory department under the State Council. Where an applicant does not make such an application or the original interim standard fails to fulfill the requirements for the formalization, the drug regulatory department under the State Council shall withdraw the interim standard and the approval number for drug production issued on the basis of the said interim standard.

Article 33 For alteration of any items indicated in the approval documents and their attachments for new drug research and development, production or importation of a drug, a supplementary application shall be submitted to the drug regulatory department under the State Council; if all the requirements are fulfilled upon review, an approval shall be given by the drug regulatory department under the State Council.

Article 34 The drug regulatory department under the State Council may, based on the needs for protection of public health, set an observation period of not more than five years for a new drug produced by a drug manufacturer; and no approval shall be given to any other manufacturer to produce or import the said drug during the observations period.

Article 35 The State protects undisclosed data of drug study and others which are independently acquired and submitted by drug manufacturers or sellers to obtain production or marketing approval of the drugs in question which contain new chemical entities. No one may make unfair commercial use of the said data.

Within six years from the date a drug manufacturer or seller obtains the approval documents for producing or marketing a drug containing new chemical entities, if any other applicant uses the data mentioned in the preceding paragraph to apply for approval for production or marketing of the drug in question without permission of the original applicant who has obtained the approval, no approval may be given to any other applicant by the drug regulatory department except that the data submitted are acquired independently.

No drug regulatory department may disclose the data set forth in the first paragraph of this Article except
(1) for the need of public interests; or
(2) where steps are taken to ensure that the data are protected against unfair commercial use.

Article 36 Any drug applied to be imported shall be the one obtained marketing authorization in the country or region of manufacturing. A drug without such an authorization may be approved of its importation in accordance with the provisions in the Drug Administration Law and in the Regulations, provided that its safety, efficacy and clinical needs have been confirmed by the drug regulatory department under the State Council.

For importation of a drug, an application for registration shall be made according to provisions of the drug regulatory department under the State Council. A drug may only be imported after an Import Drug 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 37 Any medical institution that urgently needs to import a small amount of drugs shall, with a Practicing License of Medical Institution, submit an application to the drug regulatory department under the State Council, and the drugs in question may only be imported upon approval. Such import drugs shall only be used in the designated medical institution for specified purpose.

Article 38 After import drugs arrive at the port, the drug importer shall file a record with the local drug regulatory department in the place where the port is located with the Import Drug License or Pharmaceutical Product License, the original copy of the certificate or origin, duplicate copy of the purchase contract, packing list, bill of freight, shipping invoice, certificate of analysis for the release of drugs by the manufacturer, inset sheet and other documents. The said drug regulatory department shall review the documents submitted and issued a Drug Import Note if they comply with the requirements. The drug importer shall, with the Drug Import Note, complete the formalities for customs declaration and clearance with the Customs.

The drug regulatory department in the place where the port is located shall notify the drug testing institution to conduct sampling and testing of the import drugs on each batch basis with the exception of the circumstances set forth in Article 41 of the Drug Administration Law.

Article 39 Vaccines, blood products, diagnostic reagents in vitro for blood donor screening and other biological products regulated by the drug regulatory department under the State Council shall be subject to testing or review for approval according to the provisions of the drug regulatory department under the State Council before being marketed or imported; any product that fails in testing or has not been approved shall not be marketed or imported.

Article 40 The State encourages cultivation of Chinese crude drugs. Control through approval number s