Chinese people's **** and the State Drug Administration Law

Chapter I General Principles Article 1 In order to strengthen the supervision and management of medicines, to ensure the quality of medicines, improve the efficacy of medicines, to ensure the safety of the people's medicines, and safeguard people's health, the enactment of this law. Article 2 The health administrative department of the State Council shall be in charge of the supervision and management of medicines throughout the country. Article 3 The State shall develop modern and traditional medicines and give full play to their role in prevention, medical treatment and health care.

The State protects the resources of wild medicinal herbs and encourages the cultivation of Chinese medicinal herbs. Chapter II Management of Drug Manufacturing Enterprises Article 4 to open a drug production enterprises must be the province, autonomous regions, municipalities directly under the Central Drug Production and Management Department review and approval by the province, autonomous region, municipality directly under the Central Health Administration, and issued a "Drug Manufacturing Enterprises License". No "drug production enterprise license", the administrative department for industry and commerce shall not be issued "business license".

"Drug Manufacturer License" should be valid, the expiration of the re-examination of the license. Specific measures provided by the State Council health sector. Article V to open a pharmaceutical production enterprises must have the following conditions:

One, with the production of drugs compatible with the pharmacist or assistant engineer or more technicians and skilled workers.

Chinese medicine processing enterprises do not have a pharmacist or assistant engineer or more technicians, familiar with the nature of the medicine and by the county-level health administrative departments above the examination and registration of pharmaceutical workers.

Second, with the production of medicines appropriate plant, facilities and sanitation environment.

Three, with the production of drugs for quality inspection of the organization or personnel and the necessary equipment. Article VI of the drugs must be produced in accordance with the process regulations, production records must be complete and accurate.

The concoction of traditional Chinese medicine tablets must comply with the "Chinese People's **** and the National Pharmacopoeia" or provinces, autonomous regions and municipalities directly under the Central Government health administrative department of the "concoction specification" provisions. Article VII production of raw materials required for the production of drugs, auxiliary materials, as well as direct contact with the drug containers and packaging materials, must meet the requirements of medicinal use. Article 8 The drugs must undergo quality inspection before leaving the factory; if they do not meet the standard, they shall not leave the factory. Article 9 Drug manufacturers must, in accordance with the requirements of the Code of Practice for the Quality Management of Drug Production formulated by the health administration of the State Council, formulate and implement rules and regulations and hygiene requirements to ensure the quality of drugs. Chapter III Management of Drug Business Enterprises Article 10 The opening of drug business enterprises must be examined and agreed by the competent departments of drug production and operation in the local area, and approved by the administrative departments of health at or above the county level, and issued a "drug business enterprise license". No "drug business enterprise license", the administrative department for industry and commerce shall not be issued "business license".

"Drug business license" should be valid, the expiration of the re-examination of the license. Specific measures provided by the State Council administrative department of health. Article XI to open a drug business enterprises must have the following conditions:

A, with the drugs operated by the appropriate pharmacy technicians.

Enterprises dealing in traditional Chinese medicine and part-time pharmaceutical enterprises do not have pharmacy technicians, with familiar with the medicinal properties of the drugs and by the county-level health administrative departments above the examination and registration of pharmaceutical personnel.

Two, with the business premises, equipment, storage facilities and sanitary environment appropriate to the operation of drugs. Article XII of the acquisition of drugs, must be quality inspection; unqualified, shall not be acquired. Article XIII of the sale of drugs must be accurate, and correctly explain the usage, dosage and precautions; allocation of prescriptions must be checked, the prescription of drugs listed in the unauthorized changes or substitution. There are contraindications or excessive dosage of the prescription, should be refused to deploy; if necessary, by the prescribing physician to correct or re-signature, before deployment.

Sale of authentic Chinese herbs, must be labeled with the place of origin. Article XIV of the drug warehouse must develop and implement the drug storage system, to take the necessary refrigeration, moisture, pest control, rodent and other measures.

Drugs into and out of storage must implement the inspection system. Article XV of urban and rural fairs and trade markets can sell Chinese herbal medicines, except as otherwise provided by the state.

The urban and rural markets may not sell medicines other than Chinese herbal medicines, with the exception of the "drug business enterprise license". Chapter IV of the medical unit of pharmaceutical management Article XVI of the medical unit must be equipped with its medical tasks appropriate pharmacy technicians, non-pharmacy technicians shall not be directly engaged in pharmacy technology. Article XVII of medical units must be prepared by the province, autonomous regions, municipalities directly under the Central Government health administrative department for examination and approval, and issued a "preparation license.

"Preparation license" shall provide a validity period, the expiration of the re-examination of the license. Specific measures provided by the State Council administrative department of health. Article XVIII of the medical unit preparation must be able to ensure the quality of the preparation of facilities, testing instruments and sanitary conditions. Article 19 of the medical unit preparation, must be based on clinical needs and in accordance with the provisions of the quality inspection; qualified, with a doctor's prescription.

Medical units prepared preparations, shall not be sold in the market. Article 20 of the medical unit to purchase drugs, must implement the quality acceptance system. Chapter V Management of drugs Article 21 The state encourages the research and creation of new drugs.

Research and development of new drugs, must be in accordance with the provisions of the State Council administrative department of health or provinces, autonomous regions and municipalities directly under the Central Government health administrative department to submit the development method, quality indicators, pharmacology and toxicology test results and other relevant information and samples, after approval, before clinical trials or clinical verification.

Completion of clinical trials or clinical verification and through the identification of new drugs, approved by the State Council administrative department of health, issued a certificate.