Schlagwort: ‘Government Supervision’

Fujian encourages the implementation of electronic first transaction information of drugs

July 11th, 2019 | by

On October 10th, Fujian Food and Drug Administration published “Notification on encouraging drug production and management enterprises to implement electronic first transaction information of drugs”. The “Notification” indicates that pharmaceutical enterprises and medical institutes are encouraged to use the Internet to establish a drug traceability system and an electronic exchange platform for the first transaction information. The “Notification” also stipulates that the platform should comply with the relevant national laws and regulations, and undertake the corresponding legal responsibility.


来源:中国医药报 2018.10.12


The National Essential Drugs List (2018 edition) is officially released

July 11th, 2019 | by

On October 25th, the state released the “National Essential Drugs List (2018 edition)”.The “List” will be officially implemented nationally starting November 11ths. The total number of medicine on the “List” has increased from 520 to 685. The Adjustment of the “List” is based on the coverage of the main clinical diseases, focusing on cancer, pediatrics, chronic diseases, etc. adding 187 kinds of Chinese and Western medicines.


来源:制药站 2018.10.26


The electronic drug regulation will be recommissioned

July 11th, 2019 | by

On August 24th, 2018, the State Food and Drug Administration issued “Guiding Opinions on the Construction of a Drug Information and Traceability System (consultation paper)”. The “Guiding Opinion” stipulates that licensed sellers of drugs and pharmaceutical enterprises should each establish their own traceability system. The ownership of the drug traceability data is determined by the principle “who generated, who owns”. It encourages Holders, pharmaceutical enterprises, users, industry associations, third-party service agencies, and administrative departments to implement the interconnection of drug information traceability through the drug traceability collaborative service platform.

国家药监局: 重启药品电子监管

来源:医药网 2018.08.27


Opinions of the national basic medical system would be released

June 29th, 2019 | by

On September 19th, 2018, the State Council published “Guiding opinions on the improvement of the national basic medical system.” The “Guiding opinions” stipulates the establishment of a wholesome drug use monitoring platform and monitoring network system.It persists in centralized drug procurement, implements drug classification and acquisition; encourages local areas to combine basic drug system with classified medical treatment, family doctor contracting services and chronic disease health management so as to reduce the financial burden of patients. It establishes a wholesome national shortage of drug monitoring and early warning system, by the way of a reasonable purchase price, fixed-point production and unified distribution to ensure drug supply.


来源:中国制药网 2018.09.19


Anhui establishes a Drug Quality and Security Traceability System for pharmaceutical enterprises

June 29th, 2019 | by

Recently, the Anhui Food and Drug Administration issued the “Guiding Opinions on the Construction of Drug Quality and Safety Traceability System for Pharmaceutical Enterprises in Anhui Province.” The “Guiding Opinions” clarify that pharmaceutical enterprises all over the province should establish a drug traceability system in accordance with laws and regulations. The traced information content of all links of the drug business should be true, accurate and complete, and should be saved at least for five years. For those who have not yet established a traceability system and for those traceability systems who do not operate effectively, especially when included incorrect information or incomplete information, it will be seriously investigated and dealt with following relevant laws and regulations.


来源:中国医药报 2018.08.03


Anhui: The 2018 version of the medical insurance catalog is released

June 19th, 2019 | by

Recently,  Anhui Human Resources and Social Security issued the “2018 version of Anhui Basic Medical Insurance, Work Injury Insurance and Drug List of Maternity Insurance”, which will be implemented from July, 1st, 2018. The catalog includes 1481 western medicines and 1356 Chinese patent medicines. Anhui Human Resources and Social Security indicates that Anhui Province will use the unified “Drug Catalog” database. The drugs on the catalog will be coded according to the “Social Insurance Drug Classification Code”, which will be confirmed by the provincial medical insurance administrative department .


来源:中国医药报 2018.05.29


“Enforcement regulation of drug examination and approval” is released

June 19th, 2019 | by

Recently, the National Medical Products Administration published the “Enforcement regulation to reinforce confidentiality information supervision regarding drug examination and approval”, which specifies four kinds of confidential information and thirteen circumstances of revealing confidential information. The “Enforcement regulation” asserts legal rights and interests of drug registration proposers, normalizes and reinforces the confidentiality management of examination and approval of information, in order to ensure the legality and high efficiency of the operation of drug examination and approval.


来源:中国医药报 2018.05.22


National Health Commission was officially founded.

May 4th, 2018 | by

On 27th March, the Health Commission was officially founded, which is directed by Xiaowei Ma. The official name on the website has been changed from “National Health and Family Planning Commission” to “National Health Commission”. (Source: The Beijing News)


来源:新京报 2018-03-27


Health insurance: payment on the basis of sickness categories

May 4th, 2018 | by

Recently, the Ministry of Human Resources and Social Security published the recommended sickness catalog for the payment of health insurance on the basis of sickness categories. 130 kinds of sicknesses are included in the catalog. As requested, at least 100 sicknesses should be confirmed for the new payment method from place to place. The Ministry of Human Resources and Social Security also emphasized that unreasonable medical payment increases should be controlled to make sure the personal expenditure will not increase. (Source: Beijing Youth Daily)


来源:北京青年报 2018-02-28

核心提示: 人社部近日公布了医疗保险按病种付费病种推荐目录,130种疾病被列入目录。按照要求,各地应确定不少于100个病种开展按病种付费。人社部强调,控制不合理医疗费用增长,确保群众个人费用负担不增加。


New method for supervision and management of drug online sale – supervision for online sale should be in accordance with offline sales

May 4th, 2018 | by

On 9th February, the CFDA published the supervision and management method of drug online sale and asked for opinions. The method shows that drug online sales have developed very quickly. However, the supervision laws and regulations are relatively legging behind, so that there are new problems in the supervision link. The CFDA published this method to improve the supervision and ask for opinions. It is required in the method that drug online sales should be in accordance with offline sales; responsibilities should be clarified; based on internet technology of the third-party platform, using internet to supervise internet; “ordering online and delivered offline” is encouraged. (Source: VCBEAT)

总局发布药品网络销售监督管理办法 明确线上线下一致监管原则

来源:动脉网 2018-02-11