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Schlagwort: ‘Drug Saftey’

The State Council: liberating online drug selling

April 20th, 2021 | by

On April 15th, the State Council issued the “Opinions on Further Improving the Reforms of ‘Streamline the Government, Delegate Power, and Improve the Government Services.'” According to the “Opinion”, prescription drugs that are not under State supervision are allowed to be sold online as long as the source of electronic prescriptions is valid.

国务院:网售处方药部分放开!电子处方需真实可靠!

来源:医药网  2021.04.20 

4月15日,国务院发布《关于服务“六稳”“六保”进一步做好“放管服”改革有关工作的意见》(以下简称《意见》)。《意见》提出,在确保电子处方来源真实可靠的前提下,允许网络销售除国家实行特殊管理的药品以外的处方药。

Shanxi: Establishing a Drug Tracing System

December 4th, 2020 | by

Recently, the Shanxi Provincial Medical Product Administration issued the “Working Plan on Establishing Drug Information Tracing System,” which concerns the development of a framework for a drug tracability supervision system by the end of 2020. The “Plan” stipulates that drug manufactures should build their own or use a drug information traceability system established by a third-party platform to share information with the national collaborative drug traceability platform and realise the tracing of special drugs such as narcotic drugs and psychotropic drugs and selected drugs in the provincial centralised procurement.

山西省药监局出台《药品信息化追溯体系建设工作方案》

来源:新浪新闻  2020.12.04

近日,山西省药监局出台《药品信息化追溯体系建设工作方案》,计划到2020年底将完成山西省药品追溯监管系统基础开发。《方案》要求,药品生产企业应自建或选用第三方平台建立的药品信息化追溯系统,并完成和国家药品追溯协同服务平台的数据对接,基本实现麻醉药品、精神药品等特殊药品以及集中采购中标品种的全过程追溯。

Beijing: supervising the drug distribution in pharmacy chains

November 27th, 2020 | by

Recently, the Beijing Municipal Medical Product Administration issued the “Notice on Strengthing the Administration of Drug Trading by Pharmacy Chains.” The “Notice” clarifies that administration departments should strengthen the management of prescription drugs in pharmacy chains; prescription drugs and drugs marked with red OTC can only be sold when a pharmacist is present. The “Notice” stipulates that competent pharmacies in densely populated regions can provide services such as selling unpacked medicines, 24-hour drug sales, and home delivery.

北京: 严管药店药品销售 鼓励药店拆零销售

来源医药网  2020.11.27

近日,北京市药监局发布了《关于加强药品零售企业销售药品管理的通知》(以下简称《通知》)。《通知》明确,各管理部门应加强药品零售企业处方药的销售管理;执业药师不在岗时,停止销售处方药及甲类非处方药。《通知》要求,鼓励各区域内有条件的、群众需求较多的药品零售企业开展药品拆零销售、24小时售药、送药上门等药学服务工作。

New regulations of online drug trading

November 13th, 2020 | by

On November 12th, the NMPA issued the “Measures for the Supervision and Regulation of Online Drug Trading (Consultation Paper).” The paper clarifies that drug trading enterprises can only sell drugs that are allowed to be sold; special drugs such as vaccines, anesthetics and psychotropic drugs are not allowed to be traded online. The paper also indicates that drug trading enterprises that are allowed to sell prescription drugs online should check the source of electronic prescription and the dispensing in the prescription and mark the used prescription. Moreover, drug trading enterprises should provide online medical services and employ pharmacists to guide the public to use drug rationally.

药品网售新规来了:不得销售麻醉、精神药品等

来源:医药网  2020.11.13

11月12日,国家药监局公布《药品网络销售监督管理办法(征求意见稿)》。《意见稿》明确,药品网络销售不得超出企业经营方式和药品经营范围;疫苗、麻醉药品、精神药品等特殊药品不得通过网络销售。《意见稿》指出,具备网络销售处方药条件的药品零售企业应检查电子处方来源,审核处方调剂,并对已使用的处方进行电子标记;在销售同时,应当建立在线药学服务制度,配备执业药师,指导合理用药。

Solicting opinions on drug recall

October 14th, 2020 | by

On October 13th, the NMPA issued the “Measures on Drug Recall (Consultation Paper)” to solicit opinions from public. The Consultation Paper stipulates that Markeiting Authorization Holders should establisch and improve the drug recall system, collect information on drug safety issues, and investigate and evaluate defective or potentially harmful drugs in order to recall them on time.

公开征求《药品召回管理办法(征求意见稿)》

来源:医药网  2020.10.14

10月13日,国家药监局综合司公开征求《药品召回管理办法(征求意见稿)》。《征求意见稿》要求,药品上市许可持有人应当建立并完善药品召回制度,收集药品安全的相关信息,对可能存在缺陷的药品进行调查、评估,及时召回缺陷药品。

NMPA: establishing a traceabiliy system of specially regulated drugs

October 14th, 2020 | by

On August 28th, the NMPA issued the “Notice of establishing the traceability system of special drugs.” The Notice indicates that the Marketing Authorization Holders should establish traceability systems and collect the information from the traceability process to realise the traceability of special regulated drugs, such as selected drugs, before December 31st. At the meantime, the NMPA should establish a Coordination Platform of traceability systems, which provides coding rules of drug traceability codes and services that encode the IP-Adresse of traceability systems that are established by Marketing Authorization Holders to help to realise the information sharing between the different traceability systems.

国家药监局:做好重点品种信息化追溯体系建设工作

来源医药网  2020.10.14

8月28日国家药监局发布《关于做好重点品种信息化追溯体系建设工作的公告》。《公告》指出,药品上市许可持有人应建立信息化追溯系统并收集全过程追溯信息,于2020年12月31日之前,基本实现国家药品集中采购中选品种等重点品种可追溯。同时,国家药监局应建设药品追溯协同服务平台,协同平台提供药品追溯码编码规则备案和药品上市许可持有人药品信息化追溯系统地址解析服务,辅助实现不同追溯系统互通互享。

Coding rules for chinese traditional drugs

September 27th, 2020 | by

On September 25th, the NMPA issued the “Coding Rules of Chinese Traditional Drugs Included in the Reimbursement List and Pharmaceutical Preparations of Medical Institutions.” The code of Chinese traditional drugs consists of 10 digits and four sections. The first section represents Chinese traditional drugs. The second section represents different medical standards in different cities. The third section represents drug effects. The fourth section represents the name of drug. The code of pharmaceutical preparation of medical institutions consists of 16 digits and 4 sections. The first section represents pharmaceutical preparations. The second section represents different medical institutions in different cities. The third section represents medical institutions. The fourth section represents the sequence of pharmaceutical preparations in different medical institutions.

医保药品中药饮片和医疗机构制剂统一编码规则和方法

来源医药网  2020.09.27

9月25日,国家医保局印发了《医保药品中药饮片和医疗机构制剂统一编码规则和方法》。中药饮片分为4个部分共10位。其中,第1部分是中药饮片识别码,第2部分是标准分类码,第3部分是功效分类码,第4部分是中药饮片名称码。医疗机构制剂编码分4个部分16位。其中,第1部分是医疗机构制剂识别码,第2部分是行政区划代码,第3部分是定点医疗机构顺序码,第4部分是医疗机构制剂顺序码

New stipulations on medication managment in pharmacies

July 2nd, 2020 | by

On July 1st, the National Medical Products Administration issued the “Stipulations on Management of Drug Data and Records of Drugs.” The “Stipulation” clarifies that one or more types of records methods should be adopted according to the needs of activities, which include developing, producing, trading, and using drugs, and the records process should be veritable, accurate, intact, and traceable. The records can be expressed in papery, electronic or mixed forms, and the recorded data should be managed according to stipulations.

药店药品管理又有新要求了

来源:新浪医药新闻  2020.07.02

7月1日,国家药监局发布了《药品记录与数据管理要求(试行)》(以下简称《要求》),自2020年12月1日起施行。《要求》明确,从事药品研制、生产、经营、使用活动,应当根据活动的需求,采用一种或多种记录类型,保证全过程真实、准确、完整和可追溯。记录载体可采用纸质、电子或混合等形式,并应根据要求对所记录数据进行管理。

Improving the supervision on unreasonable or illegal behaviors of drug online trading

April 26th, 2020 | by

On April 24th, the NMPA held the video conference for renovating the unreasonable or illegal behaviors of drug online trading and administrating the circulation of medicines. The conference indicates that the drug online trading services should be further regulated to realize constant supervision over the entire trading process and ensure the medication safety; use the National Monitoring System to track and detect the unreasonable or illegal behaviors of drug online trading dynamically.

 

药品网络销售违法违规行为专项整治深入推进

来源: 医药网  2020.04.26

4月24日,国家药品监督管理局药品监管司主持召开药品网络销售违法违规行为专项整治及药品流通监管工作调度视频会。会议强调,应进一步规范药品网络销售和药品网络交易服务,实现全过程、全周期监管,强化公众用药安全保障;利用国家药品网络交易监测系统对网络药品经营违法违规行为进行动态跟踪检测。

 

 

Video conference on inspecting the implementation of “one-code-for-one-drug” on selected drugs

April 23rd, 2020 | by

On April 17th, the NMPA held the video conference on inspecting the implementation of “one-code-for-one-drug” on selected drugs by centralized procurement of drugs with defined quantities. The conference stipulated that manufacturers should produce selected drugs according to the manufacturing processes that are defined by the NMPA. Besides, the Marketing Authorization Holders are encouraged to establish a mature drug  traceability system to conform to the tracing requirement of “one-code-for-one-drug.”

 

落实中选药品“一物一码”带量采集专项检查视频会召开

来源:医药网  2020.04.23

4月17日,国家药监局召开国家组织药品集中采购和使用中选药品专项检查工作调度视频会议。会议要求,企业应按照药监部门核准的生产工艺生产中选药品;督促药品上市许可人建立完善信息化追溯体系,落实中选药品“一物一码”追溯要求。