Schlagwort: ‘Drug Saftey’

Tibet: supervising retail pharmacies

June 19th, 2020 | by

On April 20th, the Medical Product Administration of Tibet Autonomous Region issued the “Plan on Drug Supervision in Tibet Autonomous Region (2020).” The “Plan” indicates that drugs will be supervised in terms of their production, wholesale, trading, and usage. The “Plan” stipulates that the drug information management system, purchase channels, storage and transport state, auditing, and expiration date of drugs should be inspected, and at the same time, the sales of prescription drugs and services that provide by licensed pharmacists in retail pharmacies will be checked as well.



来源: 医药网  2020.04.22

4月20日, 西藏自治区药监局发布了“2020年西藏自治区药品监督检查计划”。“计划”明确,要在今年4月至11月对全区药品生产、批发、经营、使用单位进行检查。“计划”要求,应重点检查药品的计算机管理系统、进货渠道、储运条件、销售票帐货款一致性、有效期,同时检查药品零售企业的处方药销售和执业药师在岗服务。

Two regulations were deliberated and enacted

June 19th, 2020 | by

On March 30th, the State Administration for Market Regulation issued the “Measures for the Administration of Drug Registration” and  “Measures for the Supervision of Pharmaceutical Productions,” which will come into effect on July 1st. The two “Measures” stipulate that drug registration and manufacturing should be strictly supervised to make sure the safety of drugs. Besides, the system of Marketing Authorization Holder (MAH) should be implemented comprehensively. Moreover, a drug safety assurance system should be established to manage the life cycle of drugs.

《药品注册管理办法》等两规章审议通过   7月1日起执行

来源:医药网  2020.03.31


Ten drug traceability standards are implemented

June 19th, 2020 | by

Recently, the NMPA issued the “Basic Dataset of Drug Traceability for Marketing Authorization Holders and Manufacturers,” “Basic Dataset of Drug Traceability for Pharmaceutical Companies,” “Basic Dataset of Drug Traceability for Medical Organizations,” “Basic Technical Requirements for Drug Traceability Data Exchange,” and “Basic Dataset of Drug Traceability for Consumer Inquiry.” Up to now, ten drug traceability standards that were issued by the NMPA have been implemented.



来源:制药网  2020.03.12


A national drug use supervision platform is launched

May 27th, 2020 | by

The National Health Commission announced that a national drug use supervision platform is launched, which can provide data to support healthcare administrations to supervise and analyse the drug use. 8840 medical institutions have registered on the platform.

国家药品使用监测平台上线运行 8000多家医院已登陆

来源:医药网 2019.12.11


97 negotiations targeted drugs will be published on the internet (National Negotiation)

April 16th, 2020 | by

On December 16th, the NHSA and the National Health Commission jointly issued the “Notification on Ensuring the Usage and Supply of Drugs that are Targeted in the National Negotiation.” The “Notification” stipulated that provincial healthcare security administrations should publish the 97 negotiations targeted drugs on their centralized procurement platform and their new reimbursement drug lists. Besides, healthcare departments should regulate the usage and supply of these drugs and instruct medical institutions to reserve and use them properly according to functions, clinical requirements, and healing effects.


来源:医药网  2019.12.18


Online drug selling is being supervised

April 3rd, 2020 | by

Recently, the National Development and Reform Commission and Ministry of Commerce jointly issued the “Negative List of Market access (2019 version),” which proposed that drug production and trading companies are not allowed to sell prescription drugs directly to the public through mail or internet trade.


来源:制药网 2019.11.23


Supervising drug use in public hospitals in Inner Mongolia

April 3rd, 2020 | by

On November 18th, the office of the Inner Mongolia Health Commission issued the “Notification on Implementing the Test and Analysis of Drug Use in Public Health Institutions.” The “Notification” stipulates that Inner Mongolia will select all the Tertiary, 50% of the Secondary, and 10% of the Primary medical insurance to analyse the drug use according to the stipulation of the National Health Commission. Therefore, the safety, effectiveness, and property rights of drug use will be comprehensively evaluated.


来源:医药网 2019.11.21


“Guideline” for “Internet+Health Care” in Shandong province released

February 13th, 2020 | by

On July 11th, the Shandong Provincial Government issued the “Notification on the Construction Plan for Promoting a Demonstration Province of ‘Internet+Health Care’ from 2019 to 2020.” The “Notification” stipulates that to achieve the real-time exchange and sharing of medical data, the construction of a “traceability system of drugs,” a “pre-warning and detecting system of medicines in short supply,” and a “prescription circulation platform” should be promoted. The “Notification” indicates that the construction of “Internet Hospitals” based on medical institutes is encouraged, and the “consulting or prescribing medicine over the internet” should be widely implemented in Shandong province from 2020.

山东“互联网+医疗健康”的路线图, 来了!

来源:医药网 2019.07.15


“List of National Intensive Monitoring Drug” is released

November 13th, 2019 | by

On July 1st, the Medical Administration Bureau of the National Health Commission issued the “Notification on printing the first List of National Intensive Monitoring Drug (Chemicals and Biological Products),” 20 drugs were selected in the “List.” The “Notification” stipulates that all provinces should form a list of provincial intensive monitoring drug on the basis of the national “List” and publish it for use by various medical institutions. All medical institutions should establish a regulatory system for monitoring drugs and strengthen the management of clinical applications of them. At the same time, the prescription management of drugs outside the “List” should also be strengthened.


来源:医药网 2019.07.02

核心提示:7月1日,国家卫健委医政医管局发布了《关于印发第一批国家重点监控合理用药药品目录(化药及生物制品)的通知》,共20个药品入选。 《通知》要求, 各省应在《目录》基础上形成省级重点监控合理用药药品目录并公布,以供各类医疗机构参考;各医疗机构要建立重点监控合理用药药品管理制度,加强目录内药品临床应用的全程管理;同时,还应加强目录外药品的处方管理。

“Drug Evaluation Report in 2018” is released

November 13th, 2019 | by

On July 1st, the National Medical Products Administration(NMPA) issued the “Drug Evaluation Report in 2018.” The “Report” shows that the Drug Evaluation Centre of the NMPA reviewed and approved 106 new drugs in 2018. Although the number of applications for registration of new drugs has increased by 47%, the evaluation time has been reduced significantly in comparison to 2017. Benefiting from the accelerated drug evaluation reforms, the number of applications for registration of innovative drugs has increased significantly in 2018, of which 85% were from domestic companies. At the same time, in order to improve the quality of generic drugs, the Drug Evaluation Centre has made every effort to promote the “Quality Consistency Evaluation for Generic Drugs,” and there were eight batches of generic drugs that are involved in comparison to 2018.


来源:中国医药报 2019.07.01