Drug Quality Control 藥品質量監督(2 / 3)

(2) Provided with the business operation premis, equipment, ware hous and enviro required f distribution.

(3) Having the quality trol units or personnel adaptable the drugs to be distributed.

(4) Establishing rules and regulations to govern the quality s to be distributed.

e crude drugs be sold at fairs in urban and rural areas, except for tho specified by the State cil. No pharmaceutical preparations dispended by medical institutions are permitted to be marketed.

根據國家食品藥品監管局(the State Food and Drug Administration,簡稱SFDA)發布的報告顯示,國家藥品不良反應監測中心(a’s National ter)2010年收到了692,904份藥品不良反應(adver drug rea,簡稱ADR)報告,報告數量相比2009年增長了8.4%。報告顯示,我國藥品安全風險主要集中在抗感染藥(anti-iis)和中藥注射劑(traditional e medie treatments)。除了藥物本身的作用,藥物濫用(abu of medication)也會引起不良反應。

Key words & Sentences

關鍵詞句全知道

The state should reinforce the supervision quality.

國家應當加強對藥品質量的監督管理。

What are the quences of taking medies without drug quality testing?

服用未經過藥品質量檢驗的藥品會產生怎樣的後果?

The unqualified medies will verely damage people’s health.

不合格的藥品會對身體健康造成嚴重損害。

The quality aspect of the medial product is indepe of its traditional u so that nation should be made with regard to the necessary physico-chemical, biological and microbiological tests.

藥品質量方麵是獨立於傳統應用的部分,關於其必要的理化的、生物的和微生物的試驗是不能缺少的。

Watg doctor and taking medie are unavoidable in our lives.

看病吃藥是人們的生活中不可避免的。

Drug quality trol is esntial for people’s lives ah.

藥品質量監管對於保證百姓生命健康是至關重要的。

CEPs are certificates issued by the EDQM (European Directorate for the Quality of Medies), to firm that a certain active substance is produced acc to the requirements of the relevant monograph of the European Pharmacopoeia or of the monograph on TSE.

CEP證書是由EDQM(歐洲藥品質量管理局)頒發的,用以證明某個活性物質是根據歐洲藥典的相關專論或TSE專論的要求來生產的。

The drug producer and distributor must strictly ply with pharmaceutical produ and quality ma standards.

藥品生產商和銷售商必須嚴格遵守藥品生產和質量管理規範。

The drugs should ply with the National Drug Standards.

藥品必須符合國家藥品標準。

Drug quality supervision is an important po of social curity system.

藥品質量監管是社會保障體係的一個重要組成部分。

The state adopts a prote system for certain traditional e medies.

國家實行中藥品種保護製度。

The drug monit is to be strengthened.

藥品監管工作有待加強。