Archive for March, 2018
The reformation of the State Council institutions: repealing CFDA and establishing the Drug Administration
The reformation scheme of the State Council institutions was published on 13.03.2018. It was mentioned in the scheme that the National Market Supervision Administration will be established as a subordinate institution of the State Council. Furthermore, concerning the particularity of drug supervision, the National Drug Supervision Administration will be independently established, which will be directed by the National Market Supervision Administration. The market supervision will be directed hierarchically. The drug supervision institutions will be set only to the provincial level. The supervision of drug distribution and drug sales will be operated by the supervision administrations at the city and country level. The CFDA will not be kept in the reformation. (Source: people.cn)
国务院机构改革: 撤销食药监总局、单设药监局
来源：人民网 2018-03-14
核心提示：国务院机构改革方案于2018年3月13日公布。方案提出，组建国家市场监督管理总局，作为国务院直属机构。其中，考虑到药品监管的特殊性，单独组建国家药品监督管理局，由国家市场监督管理总局管理。市场监管实行分级管理，药品监管机构只设到省一级，药品经营销售等行为的监管，由市县市场监管部门统一承担。并不再保留国家食品药品监督管理总局。
65 licensed pharmacists got publicized! The CFDA exposes the situation of fake subordinations for the first time
On 22nd November, the CFDA published an announcement about the inspection of fake subordinations of licensed pharmacists in pharmaceutical distributors. It is known that the FDA in Jilin and some other provinces found 65 licensed pharmacists with fake subordinations. The FDAs have registered the information of those pharmacists in the management information system of national licensed pharmacists. The provincial registration institution of licensed pharmacists will capture and de-register their certificate and make them public. (Source: 21st Century Pharmacy)
65人被公示！CFDA首次曝光执业药师“挂证”情况
来源：21世纪药店 2017-11-23
核心提示: 11月22日，国家食品药品监督管理总局网站上发布《关于药品经营企业中执业药师“挂证”行为检查情况的通告》。据悉，吉林等省(自治区)食品药品监管部门检查发现“挂证”行为的执业药师65人。相关食品药品监管部门已将上述“挂证”人员相关信息录入全国执业药师注册管理信息系统，由所在省执业药师注册机构依照相关规定收缴其注册证，并注销注册、对外公示。
10 pharmacies became pilot stations for recycling expired drugs
To safeguard the pharmaceutical market order, one should avoid that expired drugs flow into the market and endanger the medication safety. The Committee on Capital Markets Regulation Tianjin organized that the pharmaceutical drug retailers start the recycling of expired drugs. On 29th November 2017, the long-term basis recycling work of expired drugs officially started. For the first batch, 10 pharmacies became pilot stations. (Source: China Network Finance)
天津10家药店试点过期药回收
来源：中国网财经 2017-11-30
核心提示: 为保障药品市场秩序，防止过期药品流入市场，保证百姓用药安全，天津市市场监管委组织天津市药品零售企业积极开展过期药品回收工作。2017年11月29日，天津市过期药品长期回收活动正式启动，首批10个药店纳入试点。
The supervision and management regulation for drug retailing online seeks for opinions: Prescription drugs are forbidden to sell online
CFDA recently publishes the supervision and management regulation for drug retailing online (exposure draft) and asks for opinions from the public. The exposure draft emphasizes that pharmacies online should neither sell prescription drugs, nor exhibit information of them. Licensed pharmacists are also necessary for pharmacies online. These are also the latest management regulation for pharmacies online, which will further enhance the distribution environment of drug retailing online and maintain the medication safety. (Source: Souhu)
网络药品经营监督管理办法征求意见：处方药禁止网售
来源：搜狐 2017-11-17
核心提示：国家食品药品监督管理总局组织起草了《网络药品经营监督管理办法（征求意见稿）》，并向社会公开征求意见。征求意见稿强调了网上药店不能违规销售处方药、不得展示处方药信息、须配备执业医师等相关要求。这也是最新针对网上药店的管理办法，将进一步强化网络药品经营流通环境、维护用药安全。
The standard of drug data management asks for opinions
Recently, regarding the standard of drug data management, CFDA asks for opinions of the public. The exposure draft of the standard indicates that data management is one part of the system of the drug quality management, which should run through the entire data life cycle. (Source: Health News)
《药品数据管理规范》征求意见
来源：健康报 2018-01-11
核心提示：近日，国家食品药品监督管理总局再次就《药品数据管理规范》向社会公开征求意见。《规范》征求意见稿指出，数据管理是药品质量管理体系的一部分，应贯穿整个数据生命周期。