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Notice of the State Food and Drug Administration on the regulation of traditional Chinese medicine production and operation order and severely punish illegal behavior

Release time:[2012-11-09]       Returns

Notice of the State Food and Drug Administration on the regulation of traditional Chinese medicine production and operation order and severely punish illegal behavior

The State Food and Drug Administration [2012]187

The provinces, autonomous regions, municipalities directly under the central government, the food and Drug Administration (FDA Bureau ):

In recent years, the food and drug regulatory departments at all levels continue to increase the production of Chinese traditional medicine circulation supervision, efforts to maintain the overall stability of the quality of traditional Chinese medicine. But with the increasingly fierce market competition, increasing yield and demand contradictions, price fluctuations, problems of Chinese traditional medicine production and circulation field is prominent, the sale of counterfeit goods are on the rise. To reduce some traditional Chinese medicine production enterprises, laissez-faire irregularities, and provide convenience for the production and sale of counterfeit goods, or even directly involved in illegal activities, serious interference of Chinese medicine production and operation order, directly affect the safe and effective use of drugs, trigger social attention. In order to regulate the production of Chinese traditional medicine management order, and severely punish illegal behavior, strengthen supervision, to ensure the quality of traditional Chinese medicine, the relevant requirements are hereby notified as follows.

One, strengthen supervision and management to regulate traditional Chinese medicine production and operation order

( a ) the Chinese herbal medicine, proprietary Chinese medicine production enterprises should ensure the use of herbs, habitat stability, promoting the construction of traditional Chinese medicine base, and actively guide the planting, the scale of Chinese medicine. To strengthen the detection and control of toxic heavy metal elements, pesticide residues, aflatoxin and other safety indicators, and ensure the quality and safety of Chinese medicinal herbs.

( two ) pieces of Chinese medicine production enterprises should be carried out in strict accordance with the GMP requirements of production and processing standards, with test equipment and the ability to adapt and varieties of production, strict quality inspection, inspection for each batch of the purchase of medicines and the production of medicine, ensure the quality of prepared herbal medicine.

( three ) Chinese medicine production enterprises should be strictly in accordance with GMP production, strict raw materials, intermediate products and finished product quality first quality, effectively assume responsibility. Traditional Chinese medicine should have adapted to the production of varieties of pretreatment, extraction ability, guarantee the production system, strengthening the quality control of the whole process of production. In strict accordance with the drug standard feed production, prescription under the provisions for the pieces of feed not to medicinal material feeding, provisions for the extract of Chinese medicine material, can be used directly to extract the feed. Have to buy raw materials, intermediate products, manufactured products, equipment and the ability of the whole test. To establish a preventive medicine slag disposal system extraction residue waste reflux drug market, to prevent lawless use. The use of Chinese medicine extract feed production enterprises, we should strengthen the quality audit to extract production enterprise, the fixed extract is derived, and the extract of suppliers and other information submitted to the provincial food and Drug Administration drug registration departments for the record, change to record. Shall not be used without the " drug production license " enterprises in the production of products, shall not be used without the national drug standard products. Proprietary Chinese medicine production enterprises should strengthen the enterprise or the group of traditional Chinese medicine extraction workshop construction, to meet the requirement of the corresponding varieties from production and quality control need. Temporarily do not have the ability to extract, to propose solutions and specific time as soon as possible, the Provincial Bureau for approval, can continue to follow the " on the strengthening of pretreatment and extraction of supervision work notice " (State Drug Administration ( 2002 ) No. 84 ) the relevant requirements of the implementation. The provincial food and drug administration should be strictly approval of new commissioned extraction application, strengthen the request from the daily supervision and inspection, and urge enterprises to implement the solution, does not meet the requirements, shall be ordered to suspend production.

( four ) medical institutions, enterprises should hold " GMP inspection certificate " pieces of production enterprise or business enterprise purchase herbal pieces hold pieces of " drug" GSP certificate, and obtain legal bills. Strict implementation of the relevant provisions of the drug GSP and " hospital medicine management norms ", perfect management system and measures of purchase records, acceptance, storage, transportation, dispensing, facing processing process. It is forbidden to engage in medicine packing, label changes etc.. Is strictly prohibited from Chinese herbal medicine market or other do not have the units or individuals purchase herbal pieces of production management quality, ensure safety of traditional Chinese medicine.

Two, resolutely investigate and deal with illegal activities such as the production and sale of counterfeit goods

( a ) a crackdown on Chinese herbal medicine market of illegal behavior. In Chinese herbal medicine market bootlegging, adulteration, weight gain staining, filled with bad illegal behavior, is an important source of counterfeit medicines. To thoroughly investigate the source in the fight against counterfeit medicines, and destroyed and Chinese herbal medicine market collusion of manufacturing and selling counterfeit and inferior Chinese herbal medicine, Chinese medicine Yinpian " black dens "; strengthen the management and supervision and inspection, crack down on counterfeit medicines distribution behavior; check and blocking the flow of counterfeit medicines, to prevent counterfeit medicines into the regular production and circulation areas; resolutely investigate and deal with Chinese herbal medicine market sales of Chinese herbal pieces, toxic herbs, medicine, business, medicine professional market order specification.

( two ) violations severely punished proprietary Chinese medicine production process. Focus on: the use of weighting dyeing, contaminated or extraction of counterfeit medicines and herbal feed production, illegal use of Chinese medicine extract instead of Chinese herbal medicine feed production; buy no national standards or not through the traditional Chinese medicine extract GMP inspection of feed production; Jerry, not according to the formula feeding, not according to the provisions of processing, violating the production process, not according to the provisions of the inspection of illegal behavior; the extraction waste residue sold to criminals, resulting in the dregs of reflux drug market.

( three ) the illegal behavior of severe and Chinese medicine Yinpian production process. Focus on: the use of counterfeit medicines, contaminated or extraction of Chinese herbal medicine for feed production; adding other substances in the production process pollution caused pieces; outsourcing pieces of Chinese medicine (including semi-finished products ) are divided into packaging or change the packaging label; lending licenses, Xukai bill, provide product inspection report for the criminals; not to the processing standards or beyond the approved scope of processing, not according to the prescribed inspection; collusion fraud and other illegal acts and the " black dens ".

( four ) severe and Chinese medicine Yinpian circulation use link illegal behavior. Focus on: the purchase of, pharmaceutical trading enterprises and medical institutions of the sale and use of weight gain, dyeing, contaminated medicines and extraction and other counterfeit medicine; herbal medicine to processing and sales of fake; lending licenses, Xukai bill; and the " black dens " collusion fraud; illegal purchase medicine violations from illegal channels. On the illegal behavior, all in accordance with the " Drug Administration Law " and relevant regulations severely punished; to find and " black dens " collusion fraud, dig deeper investigation, severe blow; suspected of a crime, will be transferred to public security organs.

Three, strengthen the organization and leadership to implement the regulatory responsibility

( a ) improving the ideological understanding, strengthen organization and leadership. To a profound understanding of the importance and urgency of strengthening the supervision and management of production and operation, Chinese crackdown on counterfeit behavior. The provincial food and drug administration should focus on the overall situation, actively implement the National Bureau requirements, combined with the local reality and Chinese herbal medicine special professional market requirements, carefully organized, careful deploy, elaborate arrangement, to ensure that the work carried out in an orderly manner, and obtain the actual effect. To eliminate hidden dangers and prevent systemic problems, traditional Chinese medicine, to ensure product quality, ensure public safety.

( two ) increase the supervision and inspection and supervision and inspection efforts. Around to the possible effect of traditional Chinese medicine quality problems and supervision of the weak links, carry out on-site inspection work in the production of Chinese traditional medicine, business enterprises to focus on the. The inspection focused on Chinese herbal medicine and herbal sources, formulation and process, material balance, quality inspection, check the purchase, sale, transfer, contract and notes record. To improve the examination methods, improve the inspection efficiency, take a variety of ways, the initiative to collect clues, investigate openly and secretly, in-depth investigation, do great hidden problems early discovery, early repair. The state will strengthen the inspection frequency, and urged all localities to implement the work requirements. All localities should strengthen supervision and inspection of traditional Chinese medicine, Chinese herbal medicine market sampling plan, increase the production of Chinese traditional medicine enterprises, trading enterprises and medical institutions (including clinics ) each link of the testing strength, in the process of inspection found problems focus on product testing, improve the raw materials (including Chinese Medicine extract ), according to the product and the market circulation products sampling.

( three ) to strengthen the work of investigating and handling cases. For a variety of on-site inspection and sampling inspection found illegal behavior, all localities should take immediate measures to control, find by hard and thorough search, check the end, never palliative, shall be punished severely; relates to the area outside, shall promptly inform the relevant local food and Drug Administration investigation; for the manufacture and sale of fake medicines, involving a wide range, the danger of major cases, shall timely the report. To constitute a crime, should be promptly transferred to public security organs. For the discovery of not standardized production and management behavior, to urge enterprises to take measures timely rectification. The National Bureau of the composition of the inspection team and the steering group, to conduct supervision and inspection and supervision, and a number of major cases, the exposure of a number of serious illegal enterprises, a powerful deterrent to criminals, the traditional Chinese medicine production and operation order fundamental turn for the better.

( four ) to supervise the enterprise strictly implement the drugs GMP and GSP. All localities should be on-site inspection and daily supervision work organically, increase the new revised Drug GMP and GSP implementation efforts, speed up the progress of work, provide powerful support for the specification of Chinese medicine production and operation order. The provincial food and Drug Supervision Bureau will organize the spirit of this notice and timely communication to the area related to the production and operation enterprises. Problem encountered in the implementation, should be timely to reflect the national bureau.

The State Food and Drug Administration in July 18, 2012



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