Drug addicts as mentioned in these Regulations refer to medical institutions, family planning technical service institutions and units engaged in disease prevention, rehabilitation and health care, drug rehabilitation and other activities. Article 4 The people's governments at or above the county level shall lead the work of drug supervision and administration within their respective administrative areas, clarify the supervision responsibilities, improve the supervision system, increase public investment, and establish and improve the coordination system of drug supervision and administration and the response mechanism for drug safety emergencies; Township people's governments shall, according to needs, do a good job in drug supervision and management within their respective administrative areas.
The provincial drug supervision and administration department is in charge of the drug supervision and administration in the whole province, and the relevant departments of the people's governments at the city and county level divided into districts (hereinafter referred to as the drug supervision and administration department) are responsible for the drug supervision and administration within their respective administrative areas. Other relevant departments shall be responsible for drug supervision and administration within their respective functions and duties. Article 5 Provincial, municipal and state pharmaceutical supervisory and administrative departments may entrust subordinate pharmaceutical supervisory and administrative departments to perform administrative licensing and other relevant pharmaceutical supervisory and administrative duties according to law.
Pharmaceutical professional technical institutions set up or designated by provincial drug supervision and administration departments shall undertake the review, inspection, verification, monitoring and evaluation required for the implementation of drug supervision and administration according to law. Article 6 The holder of drug marketing license shall be responsible for non-clinical research, clinical trials, production and marketing, post-marketing research, adverse reaction monitoring, reporting and handling of drugs according to law. Other units and individuals engaged in drug research, production, sale, storage, transportation and use shall bear corresponding responsibilities according to law.
Pharmaceutical societies, medical associations, licensed pharmacists' associations, advertising associations, price associations and other organizations should strengthen industry self-discipline, guide pharmaceutical production and marketing enterprises and users to produce, market and use drugs according to law, promote the construction of industry integrity, publicize and popularize drug knowledge, and provide scientific and accurate drug information and consulting services.
The news media should carry out public welfare publicity of drug laws and regulations, drug standards and knowledge, refuse to publish and broadcast illegal drug advertisements, and conduct public opinion supervision over drug violations. Article 7 Any organization or individual has the right to report illegal acts in drug research, production, trading, use and supervision and management, and put forward opinions and suggestions on drug supervision and management.
The pharmaceutical supervisory and administrative departments and relevant departments shall establish and improve the system of information disclosure, complaint, report and reward. Chapter II Drug Research and Production Management Article 8 Drug research institutions and production enterprises are encouraged to research and develop safe, effective, cheap and convenient drugs. Support the production of special drugs and emergency drugs.
Encourage and guide pharmaceutical production enterprises to improve their independent innovation ability and optimize and upgrade the pharmaceutical industry. Article 9 Drug research shall conform to the provisions of the national quality management standards for non-clinical drug research and the quality management standards for clinical drug trials.
The original records of drug research and the materials for applying for drug registration shall be true, complete and standardized.
To apply for clinical trials of new drugs, registration of new drugs and registration of drugs with national standards, samples shall be prepared in accordance with state regulations. Article 10 Whoever engages in pharmaceutical production activities shall abide by the good manufacturing practice, establish and improve the quality management system of pharmaceutical production, and ensure that the whole process of pharmaceutical production continuously meets the statutory requirements.
The holder of a drug marketing license shall establish a drug quality assurance system, be equipped with specialized personnel, and be independently responsible for drug quality management. Eleventh Chinese herbal pieces should be processed in accordance with the national drug standards; If there is no provision in the national drug standard, it shall be processed according to the processing standard formulated by the provincial drug supervision and administration department.
Chinese herbal pieces that do not meet the national drug standards or are not processed in accordance with the processing standards formulated by the provincial drug supervision and administration departments shall not leave the factory or be sold. Article 12 The raw and auxiliary materials used in the production of drugs and preparations must meet the requirements of medicinal use and be tested according to the standards. Only qualified materials can be put into use. Thirteenth production of drugs and preparations must have a true, complete and standardized production (preparation) records and inspection records; All kinds of records shall be kept for one year after the expiration of the validity period of drugs, but not less than three years. Article 14 In addition to the processing of Chinese herbal pieces, pharmaceutical production enterprises must feed materials according to the prescription ingredients and prescription quantity stipulated in the national drug standards, and produce drugs according to the production technology approved by the national drug supervision and administration department. Article 15 If a pharmaceutical production enterprise (workshop) stops production for more than six months within the validity period of the Pharmaceutical Production License, it shall report to the local pharmaceutical supervisory and administrative department for the record within three days after resuming the production of pharmaceuticals, and accept the supervision and inspection and sampling inspection by the pharmaceutical supervisory and administrative department.