中新网7月20日电 据国家食药监局网站消息，日前，药监局下发《关于规范中药生产经营秩序严厉查处违法违规行为》通知，通知要求，各级食品药品监管部门要加强对经营业户的监督检查，严厉打击经销假劣药材的行为，查清并阻断假劣中药材流向，严防假劣中药材进入正规生产流通领域。

Beijing, July 20 (Reuters) according to the state, the administration's food web news，a，Issued by the administration's《On regulating the management order of traditional Chinese medicines tough on illegal irregularities》notice，Notice requirements，The food and drug administration departments at all levels should strengthen the supervision and inspection of the business to business，To crack down on distribution JiaLie medicinal materials behavior，Find out JiaLie flow and block Chinese，Defend JiaLie Chinese traditional medicine into a regular production and circulation field。

　　《通知》指出，近年来，各级食品药品监管部门不断加大中药生产流通监管力度，努力保持中药质量总体稳定。但随着市场竞争日趋激烈，中药材产量与需求矛盾加剧，价格剧烈波动，中药生产流通领域问题突出，制假售假现象有所抬头。一些中药生产经营企业降低要求，放任不规范行为，为制假售假提供方便，甚至直接参与违法活动，严重干扰中药生产经营秩序，直接影响公众用药安全有效，引发社会高度关注。

《notice》Points out that，In recent years，The food and drug administration departments at all levels rising Chinese medicine production and circulation supervision，Try to keep Chinese traditional medicine quality overall stability。But with the market competition is becoming increasingly fierce，Chinese herbal medicine production and demand contradictions intensified，Prices fluctuated violently，Traditional Chinese medicine production and circulation field problems，Counterfeit phenomenon, is back。Some Chinese herbal medicine production management enterprise to reduce demand，Indulge irregularities，Provide convenience for counterfeit，Even directly participate in illegal activities，Serious interference of traditional Chinese medicine production and operation order，Direct influence public drug is safe and effective，Trigger social concern。

　　《通知》要求，加强监督管理规范中药生产经营秩序，一是中药饮片、中成药生产企业应保证其使用的中药材来源、产地稳定，推进中药材基地建设，积极引导中药材规范化、规模化种植。加强对重金属及有害元素、农药残留、黄曲霉毒素等安全性指标的检测和控制，切实保证中药材质量和安全。

《notice》requirements，Strengthen the supervision and management standard the management order of traditional Chinese medicines，One is the Chinese medicine yinpian、Traditional Chinese medicine production enterprise shall ensure that the use of the Chinese herbal medicine source、Origin stability，Promote Chinese herbal medicine base construction，Actively guide Chinese herbal medicine standardized、Scale of planting。To strengthen the heavy metal and the harmful elements、Pesticide residues、Yellow aspergillus toxin safety index such as the detection and control，Really ensure the quality and safety of Chinese herbal medicine。

　　二是中药饮片生产企业应严格按照GMP要求和炮制规范进行炮制生产，具备与生产品种相适应的检验设备和能力，严把质量检验关，对每批购进的中药材和所生产饮片进行检验，保证饮片质量。

2 it is Chinese medicine yinpian production enterprise shall strictly according to the GMP requirements and processing standard processing production，Have to adapt the varieties and production test equipment and ability，Strictly the quality JianYanGuan，Purchases of each lot of Chinese medicinal materials and production yinpian inspection，Guarantee yinpian quality。

　　三是中成药生产企业应严格按照GMP组织生产，严把原料、中间产品和成品质量关，切实承担起第一质量责任人的职责。应具备与生产品种相适应的中药前处理、提取能力，保证生产体系完整，强化生产全过程的质量控制。严格按照药品标准投料生产，处方项下规定为饮片投料的不得以药材投料，规定为中药提取物投料的，方可直接使用提取物投料。具备对购入原料、中间产品、出厂产品进行全项检验的设备和能力。建立能够防范提取药渣废料回流药品市场的药渣处置管理制度，严防被不法分子利用。

Three is proprietary Chinese medicine production enterprise shall strictly according to the GMP production organization，Strictly the raw material、Intermediate products and finished product quality，To assume responsibility of the person in charge of quality first。Should have and production of adaptation of the traditional Chinese medicine preparation、Extracted from，Ensure the production system integrity，Strengthening the whole production process quality control。In strict accordance with the drug standards feed production，Under a prescription for slices of release in provisions medicinal feeding，Provisions for Chinese herb extract the release，Can use directly extract feeding。Have to buy raw materials、Middle product、The products out of the factory for the whole of the equipment and inspection ability。Establish can prevent reflux extraction liquid waste disposal of liquid drug market management system，Fight to be criminals use。

　　使用中药提取物投料的生产企业，应切实加强对提取物生产企业的质量审计，固定提取物来源，并将提取物供应商等信息报送省级食品药品监管局药品注册部门备案，发生变更时应重新备案。不得使用无《药品生产许可证》企业生产的产品，不得使用无国家药品标准的产品。

Use Chinese herb extract of feed production enterprise，Should reinforce to extract production enterprise quality audit，Fixed extract source，And will extract the information such as the supplier submit provincial bureau of the food and drug administration drug registration department for the record，Change the record should be。Shall not use without《Pharmaceutical production license》Enterprise produced products，Without the national drug standards shall not use the products。

　　中成药生产企业应加强本企业或本集团中药提取车间建设，使之完全适应相应品种提取生产和质量控制需要。暂时不具备提取能力的，要尽快提出解决方案和具体时限，报省局备案同意后，可以继续按照《关于加强中药前处理和提取监督管理工作的通知》有关要求执行。各省级食品药品监管局应从严审批新的委托提取申请，加强委托提取日常监督检查，督促企业实施其解决方案，不符合要求的，责令暂停生产。

Traditional Chinese medicine production enterprises should strengthen the enterprise or the group construction of Chinese traditional medicine extraction workshops，To fully meet the corresponding varieties extraction production and quality control needs。Temporary don't have the ability of the extraction，As soon as possible solutions and specific time limit，For the record ShengJu consent，Can follow the《On strengthening the traditional Chinese medicine preparation and extracting supervision and management of the notice》Requirement for execution。Each provincial bureau of the food and drug administration should declare new application for examination and approval by extraction，Strengthen entrust extraction routine supervision and inspection，Supervise the implementation of enterprise solution，Do not comply with requirements，Shall be ordered to suspend production。

　　四是药品经营企业、医疗机构应从持有《药品GMP证书》的饮片生产企业或持有《药品GSP证书》的饮片经营企业采购中药饮片，并索取合法票据。严格执行药品GSP和《医院中药饮片管理规范》有关规定，完善购进记录、验收、储存、运输、调剂、临方炮制等过程的管理制度和措施。严禁从事饮片分包装、改换标签等活动。严禁从中药材市场或其他不具备饮片生产经营资质的单位或个人采购中药饮片，确保中药饮片安全。

Four is the drug business enterprise、Medical institutions should hold《Medicine GMP certificate》Production enterprise or held the slices《Drug GSP certificate》The business enterprise purchase prepared Chinese medicine yinpian，And for legal bills。Strict execution drug GSP and《The hospital Chinese medicine yinpian standard management》Relevant provisions，Perfect purchase records、acceptance、storage、transportation、adjust、The party processing process and so on management system and measures。It is strictly prohibited to engage in yinpian points packaging、To change the label and other activities。Herbs are strictly prohibited from market or other do not have prepared the production and business operation qualification unit or individual purchasing Chinese medicine yinpian，Ensure that Chinese medicine yinpian security。

　　《通知》要求，坚决查处制假售假等违法违规行为，一是严厉查处中药材专业市场违法违规行为。中药材专业市场存在的制假售假、掺杂掺假、增重染色、以劣充好等违法违规行为，是假劣中药材的重要来源。要彻查假劣中药材源头，打击并捣毁与中药材专业市场勾结的制售假劣中药材、中药饮片的“黑窝点”；加强对经营业户的监督检查，严厉打击经销假劣药材的行为；查清并阻断假劣中药材流向，严防假劣中药材进入正规生产流通领域；坚决查处中药材专业市场销售中药饮片、毒性药材、药品制剂等经营行为，规范中药材专业市场经营秩序。

《notice》requirements，We will tenaciously investigate illegal activities such as counterfeit，One is investigated and severely illegal Chinese professional market。Chinese herbal medicine professional market existence of counterfeit、Doping adulteration、Increase heavy staining、Has been filled with bad illegal activities such as，JiaLie is an important source of Chinese herbal medicine。To investigate JiaLie Chinese herbal medicine source，Blow and destroyed and Chinese herbal medicine professional market of collusion JiaLie and Chinese traditional medicine、Of traditional Chinese medicines into ready-to-use forms“HeiWoDian”；To strengthen the supervision and inspection of the business to business，To crack down on distribution JiaLie medicinal materials behavior；Find out JiaLie flow and block Chinese，Defend JiaLie Chinese traditional medicine into a regular production and circulation field；We will tenaciously investigate Chinese herbal medicine professional market sales Chinese medicine yinpian、Toxic medicine、Pharmaceutical preparations management behavior，Standard Chinese herbal medicine professional the market operation order。

　　二是严厉查处中成药生产过程中的违法违规行为。重点查处：使用增重染色、被污染或提取过的假劣中药材及饮片投料生产，非法使用中药提取物替代中药材投料生产；购入无国家标准或未通过GMP检查的中药提取物投料生产；偷工减料、不按处方投料、不按规定进行前处理、违反生产工艺生产、不按规定检验等违法违规行为；将提取药渣废料销售给不法分子，导致药渣回流药品市场。

2 it is investigated and severely in the process of traditional Chinese medicine illegal behavior。Key and：Use increase heavy staining、Contaminated or extraction of Chinese JiaLie coreani and feed production，The illegal use of Chinese herb extract alternative herbal medicine feed production；The absence of such national standards or not purchased by the Chinese medicine GMP inspections extract feed production；jerry、Don't feed by prescription、Not according to the provisions of treatment before、Violation of production process production、Not according to the regulated illegal activities such as inspection；Will extract liquid waste sales to criminals，Lead to liquid drug market backflow。

　　三是严厉查处中药饮片生产过程中的违法违规行为。重点查处：使用假劣中药材、被污染或提取过的中药材进行投料生产；生产过程中添加其他物质造成饮片污染；外购中药饮片(含半成品)进行分包装或改换包装标签；出租出借证照，虚开票据，为不法分子提供产品检验报告；不按炮制规范或超出核准范围炮制，不按规定检验；与“黑窝点”勾结制假售假等违法违规行为。

Three is harsh and Chinese medicine yinpian production process of illegal behavior。Key and：JiaLie use Chinese traditional medicine、Contaminated or the Chinese herbal medicine to extract feed production；The production process adding other substances were caused by pollution；Purchased Chinese medicine yinpian(Including semi-finished products)Packaging or changing the packing for division label；Rent lend the licenses，XuKai bills，For criminals to provide product inspection report；Not according to the processing standards stipulated by the approved scope or beyond the processing，Does not press a regulation to inspection；and“HeiWoDian”With illegal activities such as counterfeit。

　　四是严厉查处中药饮片流通使用环节的违法违规行为。重点查处：药品经营企业和医疗机构购进、销售和使用增重、染色、被污染的中药材和提取过的及其他假劣中药饮片；擅自加工药材冒充中药饮片销售；出租出借证照，虚开票据；与“黑窝点”相互勾结制假售假；从非法渠道购买中药饮片等违法违规行为。

Four is harsh and Chinese medicine yinpian circulation in the link of use illegal activities。Key and：Pharmaceutical trading enterprises and medical organizations purchased、Sales and use of weight gain、dyeing、Contaminated Chinese herbal medicine and extraction and other JiaLie Chinese medicine yinpian；Processing medicinal materials without authorization, pretend to be Chinese medicine yinpian sales；Rent lend the licenses，XuKai bills；and“HeiWoDian”Halfway point in collusion with each other；From the illegal channel purchase Chinese medicine yinpian illegal activities such as。

　　《通知》强调，对上述违法违规行为，各地要按照《药品管理法》及有关规定严肃查处；对发现与“黑窝点”勾结制假售假的，要深挖严查，严厉打击；涉嫌犯罪的，一律移送公安机关。

《notice》emphasize，On the above illegal activities，According to all《The pharmaceutical administration law》And relevant provisions serious investigation；To find and“HeiWoDian”With the halfway point，To dig deep attracted，Crackdown on；Suspected of a crime，Will be transferred to the public security organ。