The hottest Drug Administration Law of the people'

Drug Administration Law of the people's Republic of China (adopted at the seventh meeting of the Standing Committee of the Sixth National People's Congress on September 20, 1984, and promulgated by order No. 18 of the president of the people's Republic of China on September 20, 1984. Since 19, Dr. Christian Haessler, head of innovation and head of polymer R & D center of Bayer Materials Technology Asia Pacific region, said: "Sunshine power is not the only innovative project that benefits from our high-tech materials and solutions (implemented from July 1, 1985)

Chapter 1 general provisions

Article 1 this law is formulated to strengthen drug supervision and administration, ensure drug quality, improve drug efficacy, ensure people's drug safety, and maintain people's health.

Article 2 the health administration department of the State Council is in charge of national drug supervision and administration.

Article 3 Article the state develops modern and traditional medicines and gives full play to their role in prevention, medical treatment and health care

the state protects the resources of wild medicinal materials and encourages the cultivation of traditional Chinese medicinal materials

Chapter II Administration of drug production enterprises Article 4 the establishment of a drug production enterprise must be examined and approved by the competent department of drug production and operation of the province, autonomous region or municipality directly under the central government where it is located, examined and approved by the administrative department of health of the province, autonomous region or municipality directly under the central government where it is located, and a drug production enterprise license shall be issued. Without a drug production enterprise license, the administrative department for Industry and Commerce shall not issue a business license

the drug manufacturing enterprise license shall specify the period of validity, and the license shall be re examined and issued upon expiration. The specific measures shall be formulated by the administrative department of public health under the State Council

Article 5 to set up a drug production enterprise, the following conditions must be met:

first, there must be pharmacists or technical personnel and technical workers above assistant engineer who are suitable for the drugs they produce. If there are no pharmacists or technicians above the level of assistant engineer in the processing enterprise of traditional Chinese medicine, it shall be equipped with pharmaceutical workers who are familiar with the drug properties and have been examined and registered by the administrative department of health at or above the county level

II. Have plants, facilities and sanitary environment suitable for the drugs produced

III. have institutions or personnel capable of quality inspection of the drugs produced and necessary instruments and equipment

Article 6 drugs must be produced in accordance with the technological procedures, and the production records must be complete and accurate

the processing of prepared pieces of traditional Chinese medicine must comply with the provisions of the Pharmacopoeia of the people's Republic of China or the processing specifications formulated by the health administrative departments of provinces, autonomous regions and municipalities directly under the central government

Article 7 the raw materials and auxiliary materials required for the production of drugs, as well as the containers and packaging materials in direct contact with drugs, must meet the pharmaceutical requirements

Article 8 drugs must undergo quality inspection before leaving the factory; Those that do not meet the standards shall not leave the factory

Article 9 "drug manufacturing enterprises must formulate and implement rules and regulations and health requirements to ensure the quality of drugs in accordance with the requirements of the" good manufacturing practice for drugs "formulated by the health administration department of the State Council. Chapter III Management of drug handling enterprises Article 10 the establishment of a drug handling enterprise must be examined and approved by the local department in charge of drug production and handling, examined and approved by the administrative department of health at or above the county level, and issued a "drug handling enterprise license". Without a "drug handling enterprise license", the administrative department for Industry and Commerce shall not issue a "business license"

the "drug handling enterprise license" should specify the period of validity, and when it expires, it should be re examined and issued. The specific measures shall be formulated by the administrative department of public health under the State Council

Article 11 to establish a pharmaceutical trading enterprise, the following conditions must be met:

first, pharmaceutical technicians suitable for the drugs they handle

if enterprises dealing in traditional Chinese medicine and enterprises concurrently dealing in drugs do not have pharmaceutical technicians, they should be equipped with pharmaceutical workers who are familiar with the properties of the drugs they deal with and who have been examined and registered by the administrative department of health at or above the county level

II. Have business premises, equipment, storage facilities and sanitary environment suitable for the drugs handled

Article 12 the purchase of drugs must be subject to quality acceptance; Those unqualified shall not be purchased

Article 13 the sale of drugs must be accurate, and the usage, dosage and precautions must be correctly explained; The prescription must be checked, and the drugs listed in the prescription must not be changed or substituted without authorization. The prescription with incompatibility or over dosage shall be refused to be dispensed; If necessary, it can be deployed only after the prescription doctor corrects or re signs

when selling authentic Chinese medicinal materials, the place of origin must be indicated

Article 14 drug warehouses must formulate and implement a drug storage system and take necessary measures such as cold storage, moisture-proof, insect and rat prevention

the inspection system must be implemented for the warehousing and ex warehouse of drugs

Article 15 traditional Chinese medicinal materials may be sold in urban and rural markets, unless otherwise stipulated by the state

drugs other than traditional Chinese medicine may not be sold in urban and rural market trade markets, except those holding the "drug handling enterprise license". Chapter IV pharmaceutical management of medical units Article 16 medical units must be equipped with pharmaceutical technical personnel suitable for their medical tasks, and non pharmaceutical technical personnel may not directly engage in pharmaceutical technical work

Article 17 the preparation of preparations by medical units must be examined and approved by the administrative department of health of the province, autonomous region or municipality directly under the central government where they are located, and a preparation license must be issued. The term of validity of the preparation license shall be specified, and the license shall be re examined and issued upon expiration. The specific measures shall be formulated by the administrative department of public health under the State Council

Article 18 medical units must have facilities, testing instruments and sanitary conditions that can ensure the quality of preparations

Article 19 the quality of preparations prepared by medical units must be tested according to clinical needs and regulations; Qualified ones shall be used with a doctor's prescription

preparations prepared by medical units shall not be sold in the market

Article 20 when purchasing drugs, medical units must implement the quality acceptance system. Chapter V Administration of drugs Article 21 The State encourages the research and creation of new drugs

to develop new drugs, relevant materials and samples such as development methods, quality indicators, pharmacological and toxicological test results must be submitted to the health administration department of the State Council or the health administration department of provinces, autonomous regions and municipalities directly under the central government in accordance with regulations. Clinical trials or clinical validation can be carried out only after approval

new drugs that have completed clinical trials or clinical validation and passed the identification shall be approved and issued a certificate by the health administration department of the State Council and the hospital equipped with a complete experiment, detection and analysis platform

Article 22 the production of new drugs must be approved by the administrative department of health under the State Council and issued with an approval number. However, the production of Chinese herbal pieces is excluded

the production of drugs with national standards or standards of provinces, autonomous regions and municipalities directly under the central government must be examined and approved by the administrative department of health of the province, autonomous region and municipality directly under the central government after soliciting the opinions of the competent department of drug production and trade at the same level, and an approval number must be issued. However, the production of Chinese herbal pieces is excluded

Article 23 drugs must meet the national drug standards or the drug standards of provinces, autonomous regions and municipalities directly under the central government

the Pharmacopoeia of the people's Republic of China and drug standards issued by the administrative department of health under the State Council are national drug standards

the Pharmacopoeia Committee of the administrative department of health under the State Council is responsible for organizing the formulation and revision of national drug standards

Article 24 the health administration department of the State Council and the health administration departments of provinces, autonomous regions and municipalities directly under the central government may establish drug evaluation committees to evaluate new drugs and re evaluate drugs that have been produced

Article 25 the administrative department of health under the State Council shall organize an investigation into the drugs that have been approved for production; The approval number of a drug with uncertain efficacy, serious adverse reactions or other reasons endangering people's health shall be revoked

drugs whose approval number has been revoked shall not continue to be produced and sold; Those that have been produced shall be destroyed or disposed of under the supervision of the local administrative department of public health

Article 26 it is forbidden to import drugs with uncertain efficacy, serious adverse reactions or other reasons that endanger people's health

Article 27 for a drug to be imported for the first time, the importing unit must provide the relevant materials and samples such as the instructions, quality standards, and the method of inspection, production and construction cycle of the drug, as well as the supporting documents of the exporting country (region) approving the production. Only after being approved by the administrative department of health under the State Council can the import contract be signed

Article 28 imported drugs must be inspected by drug inspection institutions authorized by the administrative department of health under the State Council; Only those passing the inspection can be imported

for a small amount of drugs that are urgently needed by medical units or for personal use, import procedures shall be handled in accordance with the provisions of the customs

Article 29 the administrative department of health under the State Council has the power to restrict or prohibit the export of Chinese medicinal materials and proprietary Chinese medicines that are in insufficient domestic supply

Article 30 the import and export of narcotic drugs and psychotropic drugs within the scope specified by the administrative department of health under the State Council must hold the "import license" and "export license" issued by the administrative department of health under the State Council

Article 31 newly discovered and introduced medicinal materials from abroad can be sold only after being examined and approved by the health administrative departments of provinces, autonomous regions and municipalities directly under the central government

Article 32 specific measures for the administration of local folk medicinal materials shall be formulated by the administrative department of health under the State Council

Article 33 it is forbidden to produce and sell fake drugs. Under any of the following circumstances, it is a fake drug:

1. The name of the ingredients contained in the drug does not conform to the national drug standards or the drug standards of provinces, autonomous regions, and municipalities directly under the central government

2. Passing off non drugs as drugs or other drugs as such drugs. Drugs under any of the following circumstances shall be treated as fake drugs:

I. The use of drugs is prohibited by the administrative department of health under the State Council

II. Production without approval number

III. metamorphism cannot be used for medicine

IV. it is polluted and cannot be used for medicine

Article 34 it is forbidden to produce and sell inferior drugs. Drugs with one of the following conditions are inferior drugs:

1. The content of drug ingredients does not conform to the national drug standards or the drug standards of provinces, autonomous regions, and municipalities directly under the central government

II. Beyond the period of validity

III. other non-compliance with drug standards

Article 35 staff members of drug manufacturing enterprises, drug trading enterprises and medical units who have direct contact with drugs must undergo annual health examinations. Patients suffering from infectious diseases or other diseases that may pollute drugs shall not engage in work that has direct contact with drugs. Chapter VI packaging and sub packaging of drugs Article 36 the packaging of drugs must meet the requirements of drug quality and facilitate storage, transportation and medical use. For drugs with a specified expiry date, the expiry date must be indicated on the package

Chinese herbal medicines must be packaged for shipment. On each package, the product name, place of origin, date and transfer out unit must be indicated, and the mark of qualified quality must be attached

Article 37 drug packages must be labeled and attached with instructions in accordance with regulations

the name, specification, manufacturer, approval number, product batch number and main components of the drug must be indicated on the label or instruction manual. Ingredients, indications, usage, dosage, contraindications, adverse reactions and precautions

the labels of narcotic drugs, psychotropic drugs, toxic drugs, radioactive drugs and drugs for external use must be printed with the specified signs

Article 38 drug handling enterprises shall repack drugs