【直报网7月3日讯】（食品药品监管总局）6月16日到6月25日，食品药品监管总局组织北京、吉林、江苏、广东、四川、陕西等6省（市）食品药品监管部门对市场上销售的银杏叶片（含分散片）、银杏叶胶囊进行了监督检查和抽样，按照食品药品监管总局公布的补充检验方法对抽取的样品进行检验，现将第一批抽验结果通告如下：

CNDSN July 3 news (food and Drug Administration) June 16 to June 25, the food and Drug Administration of the organization to Beijing, Jilin, Jiangsu, Guangdong, Sichuan, Shaanxi and other six provinces (city) food and drug regulatory authorities of market sales of ginkgo leaf (including dispersible tablets), ginkgo leaf capsule for the supervision and inspection and sampling, according to published by the food and Drug Administration of supplementary test methods to extract sample inspection, now the first batch of testing results are hereby notified as follows:

一、已完成检验284批，其中检出不合格药品67批，占全部产品的23.6%，涉及24家药品生产企业。有60批药品为企业自检不合格，监督抽验结果与企业自检结果一致。相关企业已采取召回措施并公布了召回信息。

One, has completed the inspection of the 284 batch, which detected 67 batches of substandard drugs, accounting for 23.6% of all products, involving 24 pharmaceutical production enterprises. The 60 batch of drugs for the enterprise inspection unqualified, inspection results and enterprise self consistent. Relevant enterprises have taken the recall measures and announced the recall information.

二、4家企业6批药品企业自检合格，监督抽验结果不合格。分别是：黑龙江天宏药业股份有限公司2批（银杏叶片，批号20140902A、20141012A）、吉林省跨海生化药业制造有限公司1批（银杏叶分散片，批号20140901）、宁波立华制药有限公司1批（银杏叶片，批号140705）、湖南华纳大药厂有限公司2批（银杏叶片，批号140608；银杏叶分散片，批号141005）。其中，吉林省跨海生化药业制造有限公司系食品药品监管总局《关于90家银杏叶提取物和银杏叶药品生产企业自检情况的通告》（2015年第24号）公布的自检全部批次合格的企业，其他3家为部分批次不合格的企业。经核实，上述4家企业自检系对企业留样检验的结果。抽验结果与自检结果不一致，说明企业留样与市售产品质量不一致。上述4家企业应立即启动该6批药品的召回，并按照食品药品监管总局通告2015年第24号要求，做好后续工作。同时，对此前自检结果合格的批次需根据实际上市销售产品重新进行自检，于7月10日前报告检验结果，并向社会公开相关信息。

Two, 4 enterprises in 6 batches of pharmaceutical enterprise inspection qualified, unqualified inspection results. Are: Heilongjiang timehome Pharmaceutical Co., Ltd. 2 group (Ginkgo leaf, batch number 20140902A, 20141012A), Jilin Province across the sea in the biochemical pharmaceutical manufacturing Co., Ltd. 1 group (Ginkgo biloba dispersible tablets, batch number 20140901), Ningbo liwah Pharmaceutical Co., Ltd. 1 group (Ginkgo leaf, the batch number 140705), Hunan Warner Pharmaceutical Co., Ltd. 2 group (Ginkgo leaf, the batch number 140608; Ginkgo biloba dispersion tablets, batch number 141005. Among them, the Jilin Province across the sea in the biochemical pharmaceutical manufacturing Co., Ltd. Department of food and Drug Administration of the about 90 ginkgo leaf extract and ginkgo leaf drug production enterprise self inspection notice "(2015 No. 24) announced the self-test all batches of qualified enterprises, the other three as part of the number of times not qualified enterprises. After verification, the above 4 companies to test the results of the sample test system. The testing results and the checking results are not consistent, indicating that companies sample with commercially available product quality is not consistent. These 4 companies should immediately start the 6 batch of drug recall, and in accordance with the food and Drug Administration of the twenty-fourth, 2015, the number of requests to do follow-up work. At the same time, the pre test results of qualified batches need to be based on the actual market sales of products to re check, in July 10 recently reported to test results, and to the public information.

三、在食品药品监管总局《关于桂林兴达药业有限公司等企业违法生产销售银杏叶药品的通告》（2015年第15号）和《关于宁波立华制药有限公司违法销售银杏叶药品及有关企业治理情况的通告》（2015年第17号）中要求企业应于6月3日前完成召回的企业中，有13家企业被抽到在市场上仍在售的不合格产品。分别是：安徽圣鹰药业有限公司、广东一力罗定制药有限公司、广西半宙大康制药有限公司、桂林红会药业有限公司、桂林兴达药业有限公司、湖南方盛制药股份有限公司、湖南华纳大药厂有限公司、江苏晨牌药业集团股份有限公司、江苏飞马药业有限公司、江苏润邦药业有限公司、山西仟源医药集团股份有限公司、深圳海王药业有限公司、芜湖绿叶制药有限公司。这些企业在规定完成召回的期限后，仍在市场上被抽查出不合格产品，说明企业自查不认真、召回不彻底。食品药品监管总局责令上述企业于7月10日前召回市场销售的全部不合格产品。相关省（区）食品药品监管部门加强监督力度，确保在规定召回期限之后不得在市场上再抽到该企业的不合格产品。

Third, in the food and Drug Administration of the Guilin Xingda Pharmaceutical Co., Ltd. and other enterprises illegal production and sales of Ginkgo biloba leaf drug on the circular "(2015 No. 15) and the Ningbo liwah Pharmaceutical Co., Ltd. illegal sales of Ginkgo biloba leaf medicine and relevant enterprises governance on the notice" (2015 No. 17) requires enterprises should be on June 3 days to complete the recall of the enterprises, 13 enterprises were drawn in the market is still in the sale of substandard products. It is respectively: Shengying Pharmaceutical Co., Ltd. in Anhui, Guangdong Yili Luoding Pharmaceuticals Co., Ltd., Guangxi banzhou Dakang Pharmaceutical Co., Ltd., societies Guilin Pharmaceutical Co., Ltd., Guilin Xingda Pharmaceutical Co., Ltd., Hunan Anbang Pharmaceutical Co., Ltd., Hunan Warner Pharmaceutical Co., Ltd., Chen Pai Pharmaceutical Group Co., Ltd., Jiangsu, Jiangsu Feima Pharmaceutical Co., Ltd., Jiangsu Runbang Pharmaceutical Co., Ltd., Shanxi Qianyuan Pharmaceutical Group Co., Ltd., Shenzhen neptunus Pharmaceutical Co., Ltd, Wuhu Luye Pharmaceutical Co., Ltd.. After the completion of these enterprises in the provisions of the recall period, still on the market is a non qualified products, the company is not serious, the recall is not complete. Food and drug supervision and administration shall be ordered by the above enterprises to recall all the non qualified products sold in the market in July 10 days ago. Provinces (autonomous regions) food and drug supervision departments to strengthen supervision, to ensure that in the market after the recall period is not allowed to pump the company's non qualified products.

四、海口奇力制药股份有限公司被抽验的1批药品不合格，该企业未报告自检结果。经核实，其原因是该批药品在企业自查时已判定为不合格，并已报告海南省食品药品监管局，采取了召回措施；但海南省食品药品监管局上报企业自检信息时漏报。

Four, Haikou Qili pharmaceutical Limited by Share Ltd was established in 1 batches of substandard drugs, the companies did not report self results. After verification, the reason is the group of drugs in corporate self-examination has been determined as unqualified, and have been reported to the Hainan Provincial Food and drug administration, to take the measure of recall; but the Hainan Provincial Food and Drug Administration reported self-test information is omitted.

五、上述初步抽验结果表明，前期银杏叶药品生产企业自检情况总体是可信的，不合格产品的召回取得了一定成效。多数不合格批次产品在市场上已难以抽到样品，银杏叶药品市场已得到较好的清理。

Five, the preliminary testing results show that pre ginkgo leaf drug production enterprise self inspection overall is credible, nonconforming product recall and achieved certain results. Most of the substandard batches of products in the market has been difficult to draw a sample, Ginkgo biloba leaves and drug market has been a good clean-up.

六、黑龙江、吉林、浙江、湖南省食品药品监管局要对黑龙江天宏药业股份有限公司、吉林省跨海生化药业制造有限公司、宁波立华制药有限公司、湖南华纳大药厂有限公司等4家企业产品留样与市场销售产品不一致的问题进行深入调查。对企业调换留样等伪造、隐匿有关证据材料，或者拒绝、逃避监督检查等行为的，要立案调查，并于7月10日前报告调查结果，并向社会公开说明情况。▲

Six, Heilongjiang, Jilin, Zhejiang, Hunan Province food and drug administration to the Heilongjiang timehome Pharmaceutical Co., Ltd., Jilin Province across the sea in the biochemical pharmaceutical manufacturing Co., Ltd., Ningbo liwah Pharmaceutical Co., Ltd., Hunan Warner Pharmaceutical Co., Ltd., four enterprises products left for the samples and market sales of the product is not consistent with the problems for further investigation. The enterprise change the stay like falsified, concealed the relevant evidence materials, or refused, evade supervision and inspection behavior, investigation, and on July 10 report the results of the survey and to the society publicly explained the situation. 3

（原标题：国家食药监局公布银杏叶药品专项监督抽验初步结果通告）

(original title: State Food and Drug Administration released drug Ginkgo biloba special supervision and testing the preliminary results announcement)

责任编辑：小申

Editor: small Shen