Drug Control Law of the People's Republic of China
control over drug manufacturers
control over drug distributors
control over medicines in medical institutions
control over drugs
control over drug packaging
control over drug price and advertisement
inspection of drugs
labels or marks of the drugs
drug quality control laboratory
drug regulatory agency
drug approval documents
Good Manufacturing Practice for Pharmaceutical Products (GMP)
Good Supply Practice for Pharmaceutical Products (GSP)
Drug Manufacturing Certificate
Drug Supply Certificate
Pharmaceutical Preparation Certificate for Medical Institution
New Drug Certificate
Drug Approval Number
All institutions or individuals engaged in research, production, distribution, use, and administration and supervision of drugs in the People's Republic of China shall abide by drug control law of the people's republic of China.
The drug regulatory agency of the State Council shall be responsible for drug administration and supervision nationwide.
The drug regulatory agencies of the governments of provinces, autonomous regions, and municipalities directly under the Central Government shall be responsible for drug regulation in their administrative areas.
The drug quality control laboratories established or designated by drug regulatory agencies shall undertake the responsibility for drug testing required for conducting drug review and approval and controlling drug quality pursuant to the law.
Any newly established pharmaceutical manufacturer shall be subject to approval by the local drug regulatory agency of the government of the province, autonomous region or municipality directly under the Central Government and be granted the Drug Manufacturing Certificate, and, with the certificate, the manufacturer shall be registered with the administrative agency for industry and commerce.
The term of validation and the scope of manufacturing shall be noted in the Drug Manufacturing Certificate. For renewal of the certificate on expiration, reviewing and approval again is required.
When giving approval to the newly-established manufacturer, the drug regulatory agency shall see to it that the development programs and policies set by the State for the pharmaceutical industry shall be complied with so as to prevent duplicate construction.
Any drug manufacturer to be established shall meet the following requirements: (1) stuffed with legally qualified pharmaceutical and engineering professionals and the necessary technical workers;(2) provided with the premises, facilities, and clear environment required for drug manufacturing; (3) having quality management and control units and personnel capable of quality management of and testing for drugs to be produced and the necessary instruments and equipment; and (4) establishing rules and regulations to govern the quality of drugs.
Drug manufacturers shall conduct production according to the Good Manufacturing Practice Products (GMP) formulated by the drug regulatory agency of the State Council based on this Law. The drug regulatory agency shall inspect a drug manufacturer as to its compliance with the GMP requirements and issue a certificate to the manufacturer passing the inspection.
With the exception of the processing of prepared slices of Chinese crude drugs, a drug shall be produced in conformity with the National Drug Standard and with the production processes approved by the drug regulatory agency of the State Council, and the production records shall be complete and accurate.
When drug manufacturers make any change in the production process that may affect the drug quality, they shall submit the change to the original authority for reviewing and approval.
Active pharmaceutical ingredients (API) and recipients for the manufacture of pharmaceutical products shall meet the requirements for medicinal use.
Drug manufacturers shall perform quality test of their products.
No products that do not meet the National Drug Standards or that are not produced according to the processing procedures for the prepared slices of Chinese crude drugs formulated by the drug regulatory agency of the government of a province, autonomous region, or municipality directly under the Central Government may be released.
A drug manufacturer may not accept any contract production of drugs unless it is approved by the drug regulatory agency of the State Council, or by the drug regulatory agency of the government of a province, autonomous region, or municipality directly under the Central Government authorized by the drug regulatory agency of the State Council.
Any newly established drug wholesaler shall be subject to approval of the local drug agency of the government of the province, autonomous region or municipality directly under the Central Government and be granted the Drug Supply Certificate.
Any newly established drug retailer shall be subject to approval and be granted the above certificate by the local drug regulatory agency at or above the county level.
With the Drug Supply Certificate , the wholesaler and the retailer shall be registered with the administrative agency for industry and commerce.
No one is permitted to distribute drugs without the certificate.
The valid period and the scope of business shall be indicated in the Drug Supply Certificate. For renewal of the certificate upon expiration, reviewing and approval again is required.
A drug distributor to be established shall meet the following requirements:(1) staffed with legally qualified pharmaceutical professionals;(2) provided with the business operation premises, equipment, warehouses, and clear environment required for drug distribution;(3) having the quality control units or personnel adaptable the drugs to be distributed; and(4) establishing rules and regulations to govern the quality of the drugs to be distributed.
Drug distributors shall conduct business according to the Good Supply Practice for Pharmaceutical Products (GSP) set by the drug regulatory agency of the State Council based on this Law.
The drug regulatory agency inspect a drug distributor as to its compliance with the GSP requirements, and issue a certificate to the distributor passing the inspection.
After receiving the drug purchased, drug distributors shall pass the established examination and acceptance system, and check the certificate of drug quality, labels and others marks; no drugs that fail to meet the requirements are permitted to be purchased.
Drug distributors shall keep a real and perfect records of purchasing and selling drugs.
In the record shall be indicated the adopted name of drugs, dosage form, strength or size, batch number, date of expiry, manufacturer, purchaser (or seller), amount of the drug purchased (or sold), purchase or selling price, date of purchase (or sale) , and other items specified by the drug regulatory agency of the State Council.
Drug distributors shall indicate the habitat of Chinese crude drugs to be sold.
A drug distributor shall pass the established system for drug storage, and take necessary measures to ensure drug quality, such as cold storing, protecting from being frozen and moisture and guarding against insects and rodents.
An examination system shall be followed for storing drugs in warehouse and releasing them from warehouse.
Chinese crude drugs may be sold at fairs in urban and rural areas, except those otherwise specified by the State Council.
No drugs other than the Chinese crude drugs may be sold at fairs in urban and rural areas, but drug retailers holding the Drug Supply Certificate may, within the specified business scope, sell such drugs at the stores they set up at the fairs.
Dispensing pharmaceutical preparations by a medical institution shall be subject to reviewing and permission by the health administration agency of the government of the province, autonomous region or municipality directly under the Central Government, and upon approval by the drug regulatory agency of the government. A Pharmaceutical Preparation Certificate for Medical Institution shall be issued by the above drug regulatory agency.
No medical institution is permitted to dispense pharmaceutical preparations without the Pharmaceutical Preparation Certificate for Medical Institution.
The term of validation shall be noted in the Pharmaceutical Preparation Certificate for Medical Institution. For renewal of the certificate upon expiration, reviewing and approval again is required.
The pharmaceutical preparations to be dispensed by the medical institution shall be those satisfying the clinic need of the institution but not available on the market. It shall be subject to approval in advance by the local drug regulatory agency of the government of the province, autonomous region or municipality directly under the Central Government.
No pharmaceutical preparations dispensed by medical institutions are permitted to be marketed.
A full description of a new drug research and development including the manufacturing process, quality specifications, results of pharmacological and toxicological study, and the related data as well as the samples shall, in accordance with the regulations of the drug regulatory agency of the State Council, be truthfully submitted to the above agency for reviewing and approval.
When a new drug has gone through clinical trials and passed the reviewing, a New Drug Certificate shall be issued upon approval by the drug regulatory agency of the State Council.
The institutions for non-clinical safety evaluation and study and for clinical study institutions shall respectively follow the Good Laboratory Practice for Non-Clinical Laboratory Studies (GLP) and Good Clinical Practice (GCP).