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Archive for October, 2019

Shanxi: Electronic first transaction information of drugs will be recognized

October 8th, 2019 | by

On April 26th, Shanxi Food and Drug Administersration issued the “Implementation Opinion of promoting the transformation and upgrading of pharmaceutical enterprises (consultation paper).” The “Implementation Opinion” clarified that pharmaceutical enterprises are encouraged to implement electronic management of the first transaction information of drugs under the premise of the quality, safety, and traceability. The Drug and Food Administration recognizesd the electronic first transaction information during the certification and inspection that obey the “Good Supply Practice for Pharmaceutical Products.”

山西药监局明确检查时认可电子首营

来源:新浪医药新闻  2019.04.29

核心提示:4月26日,山西省药品监督管理局发布《关于推动药品流通企业转型升级创意发展的实施意见(征求意见稿)》(下文简称《意见稿》)。《意见稿》明确,鼓励药品经营企业开展药品经营业务时,在确保药品质量安全、可追溯的前提下实行首营品种档案电子化管理。药品监管部门在实施《药品经营质量管理规范》认证检查时对电子首营资料予以认可。

A supplementary document for procurement of drugs is released(“4+7”)

October 8th, 2019 | by

On December 27th, the State Food and Drug Administration issued the “Notification on reinforcing drug supervision during the pilot of centralized procurement and use of selected drugs.” The “Notification” stipulated that each provincial drug regulatory authority should reinforce the quality supervision of the production, circulation, and use of selected drugs and the punishment for enterprises that violatie laws and regulations. The regulation authority should also urge the selected enterprises to establish a reporting system for inventory and off-production. The “Notification” indicates that the drug distribution should be regulated through related treaties to ensure the drug supply.

国家药监局发布4+7配套文件, 确保中标药品质量安全

来源:制药站 2018.12.28

核心提示:12月27日,国家药监局发布《国家药监局关于加强药品集中采购和使用试点期间药品监管工作的通知》(以下简称《通知》)。《通知》要求,各省级药品监管部门应加大对中标药品生产、流通、使用全周期的质量监管,加大违法违规企业的处罚力度,要督促中标生产企业建立企业库存和停产报告制度。《通知》指出,应通过协议规范配送行为,以保证药品供应。

The first detailed document for “procurement of drugs(“4+7”)” is released

October 8th, 2019 | by

Recently, Dalian city issued the “Implementation of a National Organised Work plan for centralized Procurement and Use of drugs (consultation paper).” The “Paper” stipulated that public medical institutions should sign a contract with the pharmaceutical production enterprises for the procurement of drugs with defined purchasing quantities and settle the payment of drugs promptly. Medical institutions should run out the contract amount within one year under the premise of ensuring the priority use of the selected drugs. The staff in medical institutions which do not use the drugs as required will be treated seriously by the relevant provisions. The Paper also clarified that the quality and use of selected drugs should be intensively monitored.

“4+7”带量采购,头一份细则文件来了!

来源:制药网 2019.01.11

核心提示:日前,大连市发布《贯彻落实国家组织药品集中采购和使用工作方案(征求意见稿)》。意见稿要求,公立医疗机构与药品生产企业应签订带量采购合同并及时结算药款,在确保中选药品优先使用的前提下,一年内完成合同用量;不按规定使用药品的医务人员,按照相应条款严肃处理。意见稿明确,应重点监测中选药品的质量和使用情况。

The pilot program of national organized centralized procurement and use of drugs is officially released

October 8th, 2019 | by

On January 17th, the General Office of the State Council officially issued the “Notification of National Organized Pivot Program for the Centralized Procurement and Use of Drugs.” The “Notification” clarified that the purchase way for each selected drug depends on the number of its production enterprises. The “Notification” stipulated that the advance payment should not be less than 30% of the purchase amount and the total purchase quantity should account for 60%-70% of the full annual drug use of public medical institutions. The centralized procurement this time will be implemented in early 2019 with one year.

国家药品集中采购和使用试点方案正式发布

来源:制药网 2019.01.18

核心提示:1月17日,国务院办公厅正式发布《国家组织药品集中采购和使用试点方案的通知》。《通知》明确,应根据每种药品入围的生产企业数量分别采取相应的集中采购方式。《通知》要求,预付金额不得低于采购金额的30%;采购总量应占公立医疗机构年度药品总用量的60%-70%。本次集中采购将于2019年初开始实施,周期为一年。

Anhui: the procurement and use of traditional Chinese medicine products is encouraged

October 8th, 2019 | by

Recently, the Anhui General Office of the People’s Government issued the “Implementation Opinion on improving the National Essential Medicine System”. The “Implementation Opinion” proposed that medical institutions should give priority to the procurement and use of essential drugs that pass the Quality Consistency Evaluation of drugs and are affordable. Some kind of High-priced and high-dose drugs should be purchased with defined quantities. The use of traditional Chinese medicine products is encouraged to support the development of Chinese medicine.

安徽发布基药新政:鼓励采购使用中药产品

来源:医药网 2019.01.14

核心提示:日前,安徽省人民政府办公厅出台《完善国家基本药物制度的实施意见》(以下简称《实施意见》)。《实施意见》提出,医疗机构应优先采购和使用通过一致性评价、价格适宜的基本药物;应对价格高、用量大的药品实施单品种带量采购;鼓励采购使用中药产品,支持中医药事业发展。