药品质量监督的英文

药品监督管理是指国家授权的行政机关，依法对药品、药事组织、药事活动、药品信息进行管理和监督;下面小编为大家整理的药品质量监督的英文，希望对大家有用!

药品质量监督的英文

The purpose of drug quality control is to eensure drug quality, guarantee drug safety, safeguard people’s health and legal rights of medication safety, with its contents of medicines management, pharmacy organization and management, management of licensed pharmacist.

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 Conical shall be responsible for drug regulation in their administrative areas. The drug quality control laboratories established or designed 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.

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 clean environment required for drug manufacturing.

(3) Having qualified management and control units and personnel capable of quality management of testing for drugs to be produced and necessary instruments and equipment.

(4) Establishing rules and regulations to govern the quality of drugs.

When 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 and recipients for the manufacturer of pharmaceutical products shall meet the requirement for medicinal use. Drug manufacturer shall perform quality test and of their products.

A drug distributor to be established shall meet the following requirements:

(1) Stuffed with legally qualified pharmaceutical and engineering professionals.

(2) Provided with the business operation premises, equipment, ware houses and clean environment required for drug distribution.

(3) Having the quality control units or personnel adaptable the drugs to be distributed.

(4) Establishing rules and regulations to govern the quality of drugs to be distributed.

Chinese crude drugs can be sold at fairs in urban and rural areas, except for those specified by the State Council. No pharmaceutical preparations dispended by medical institutions are permitted to be marketed.