Measures of Shandong Province for the Administration of Pharmaceutical Industry

Article 1 In order to strengthen the industry management of pharmaceutical production and marketing enterprises and ensure the quality of drugs, these Measures are formulated in accordance with the Drug Administration Law of People's Republic of China (PRC) and the relevant provisions of the state, combined with the actual situation of our province. Article 2 Provincial Pharmaceutical Corporation is the competent department of the pharmaceutical industry in the province, and is responsible for the industry management of the production and operation of Chinese and western medicines and medical devices in the province.

City (prefecture) and county pharmaceutical companies are the competent departments of the local pharmaceutical industry, and are responsible for the industry management of the production and operation of Chinese and western medicines and medical devices within their respective administrative areas. The main task of the third provincial department in charge of pharmaceutical industry is to implement overall planning, comprehensive balance, organization, coordination and supervision services for pharmaceutical production and operation in accordance with the principles, policies and regulations of the party and the state on pharmaceutical work. Its main responsibilities are:

First, according to the requirements of national planning, put forward the development strategy of the pharmaceutical industry in the whole province, organize the preparation of medium and long-term development plans, prepare and issue annual plans for the pharmaceutical industry, and supervise the implementation.

Two, responsible for the total quality management of the province's pharmaceutical industry, organize product quality upgrading activities, and implement the quality management standards for pharmaceutical production and operation.

Three, according to the relevant provisions of the overall management of the province's pharmaceutical industry infrastructure, technological transformation, the use of foreign capital, technology introduction. Responsible for the declaration, evaluation and appraisal of new product development, technological innovation projects and scientific and technological achievements in the pharmaceutical industry in the province.

Four, coordinate and balance the import and export of pharmaceutical commodities in the province, co-ordinate the management and use of provincial-level local special foreign exchange for pharmaceutical imports, and implement the import and export license system for Chinese herbal medicines and chemicals stipulated by the state.

Five, guide and coordinate the circulation of medical commodities in the province; Manage the production and operation of narcotic drugs, psychotropic drugs, toxic drugs and radioactive drugs in accordance with regulations; To organize and dispatch the production, storage and supply of drugs and medical devices needed for major epidemics, disasters and war preparedness; Organize pharmaceutical production and marketing enterprises to complete the mandatory plan issued by the state.

Six, organize and guide the foreign economic and technological exchanges of the pharmaceutical industry; Establish an information network to provide consulting services for pharmaceutical production and management enterprises; Responsible for the guidance and coordination of various associations in the pharmaceutical industry.

Seven, in accordance with the provisions of the state, with the provincial price department to manage the province's medical commodity prices, formulate provincial-level management of medical commodity prices or price adjustment programs, coordinate and balance the city (prefecture) management of medical commodity prices.

Eight, in conjunction with the relevant departments to organize and guide the upgrading management of pharmaceutical production and operation enterprises in the province; To guide and inspect the safety work of pharmaceutical production and marketing enterprises; Coordinate and promote various forms of horizontal economic cooperation and technical cooperation. Article 4 To establish a pharmaceutical production enterprise, an application shall be submitted to the provincial department in charge of pharmaceutical industry, submitted to the provincial health administrative department for examination and approval, and a Pharmaceutical Production Enterprise License shall be issued. With the "pharmaceutical production enterprise license" to the administrative department for Industry and commerce to apply for a "business license", can start business.

Enterprises that produce drugs with national standards or provincial and local standards must be submitted to the provincial department in charge of pharmaceutical industry for examination and approval, and approved by the provincial health administrative department for examination and approval, and an approval number will be issued.

Drugs and medical device products that have obtained the "Product Production License" shall be submitted to state administration of traditional chinese medicine for acceptance and certification after passing the inspection organized by the provincial competent department of pharmaceutical industry. Article 5 To establish a pharmaceutical trading enterprise, an application must be submitted to the competent department of pharmaceutical industry at or above the county level. After examination and approval, it shall be reported to the health administrative department at the same level for examination and approval, and a Pharmaceutical Trading Enterprise License shall be issued. With the "drug handling enterprise license" for business license, can start business. Article 6 Whoever engages in the wholesale business of drugs and medical devices must go through the examination and approval procedures in accordance with regulations. Without the approval of the competent department of pharmaceutical industry at or above the county level, no unit or individual may operate. Seventh pharmaceutical industry departments at all levels should strictly supervise and manage the drug quality of pharmaceutical production and marketing enterprises according to the Drug Administration Law of People's Republic of China (PRC). Pharmaceutical production and trading enterprises must produce, purchase and sell in accordance with national and provincial local standards. Article 8 Departments in charge of the pharmaceutical industry at all levels shall, jointly with the departments of health, industry and commerce administration, price control and public security, strengthen supervision and management of the pharmaceutical market, and investigate and deal with acts of manufacturing and selling counterfeit and inferior drugs, driving up prices and disrupting the market according to law. Ninth before the new regulations in the State Council, the "Measures for the Administration of Drugs Other than Chinese and Western Medicine" is still managed according to the existing measures. Tenth approach by the provincial pharmaceutical corporation is responsible for the interpretation of. Article 11 These Measures shall come into force as of the date of promulgation.