外國人最想和你聊的時事話題：藥品質(zhì)量監(jiān)督
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What is drug quality control 什么是藥品質(zhì)量監(jiān)督
The purpose of drug quality control is to eensure drug quality, guarantee drug safety, safeguard people's health and legal rights of medication safety, with its contents of medicines management, pharmacy organization and management, management of licensed pharmacist.All institutions or individuals engaged in research, production, distribution, use and administration and supervision of drugs in the People's Republic of China shall abide by drug control law of the People's Republic of China.
The drug regulatory agency of the State Conical shall be responsible for drug regulation in their administrative areas. The drug quality control laboratories established or designed by drug regulatory agencies shall undertake the responsibility for drug testing required for conducting drug review and approval and controlling drug quality pursuant to the law.
When giving approval to the newly-established manufacturer, the drug regulatory agency shall see to it that the development programs and policies set by the State for the pharmaceutical industry shall be complied with so as to prevent duplicate construction.
Any drug manufacturer to be established shall meet the following requirements:
(1) Stuffed with legally qualified pharmaceutical and engineering professionals and the necessary technical workers.
(2) Provided with the premises, facilities and clean environment required for drug manufacturing.
(3) Having qualified management and control units and personnel capable of quality management of testing for drugs to be produced and necessary instruments and equipment.
(4) Establishing rules and regulations to govern the quality of drugs.
When manufacturers make any change in the production process that may affect the drug quality, they shall submit the change to the original authority for reviewing and approval. Active pharmaceutical ingredients and recipients for the manufacturer of pharmaceutical products shall meet the requirement for medicinal use. Drug manufacturer shall perform quality test and of their products.
A drug distributor to be established shall meet the following requirements:
(1) Stuffed with legally qualified pharmaceutical and engineering professionals.
(2) Provided with the business operation premises, equipment, ware houses and clean environment required for drug distribution.
(3) Having the quality control units or personnel adaptable the drugs to be distributed.
(4) Establishing rules and regulations to govern the quality of drugs to be distributed.
Chinese crude drugs can be sold at fairs in urban and rural areas, except for those specified by the State Council. No pharmaceutical preparations dispended by medical institutions are permitted to be marketed.
根據(jù)國家食品藥品監(jiān)管局（the State Food and Drug Administration，簡稱SFDA）發(fā)布的報告顯示，國家藥品不良反應(yīng)監(jiān)測中心（China's National Center）2010年收到了692,904份藥品不良反應(yīng)(adverse drug reaction，簡稱ADR）報告，報告數(shù)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-infection drugs）和中藥注射劑（traditional Chinese medicine treatments）。除了藥物本身的作用，藥物濫用（abuse of medication）也會引起不良反應(yīng)。
The state should reinforce the supervision of drug quality.
國家應(yīng)當加強對藥品質(zhì)量的監(jiān)督管理。
What are the consequences of taking medicines without drug quality testing?
服用未經(jīng)過藥品質(zhì)量檢驗的藥品會產(chǎn)生怎樣的后果？
The unqualified medicines will severely 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 medicinal product is independent of its traditional use so that no derogation should be made with regard to the necessary physico-chemical, biological and microbiological tests.
藥品質(zhì)量方面是獨立于傳統(tǒng)應(yīng)用的部分，關(guān)于其必要的理化的、生物的和微生物的試驗是不能缺少的。
Watching doctor and taking medicine are unavoidable in our lives.
看病吃藥是人們的生活中不可避免的。
Drug quality control is essential for people's lives and health.
藥品質(zhì)量監(jiān)管對于保證百姓生命健康是至關(guān)重要的。
CEPs are certificates issued by the EDQM (European Directorate for the Quality of Medicines), to confirm that a certain active substance is produced according 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(zhì)量管理局）頒發(fā)的，用以證明某個活性物質(zhì)是根據(jù)歐洲藥典的相關(guān)專論或TSE專論的要求來生產(chǎn)的。
The drug producer and distributor must strictly comply with pharmaceutical production and quality management standards.
藥品生產(chǎn)商和銷售商必須嚴格遵守藥品生產(chǎn)和質(zhì)量管理規(guī)范。
The drugs should comply with the National Drug Standards.
藥品必須符合國家藥品標準。
Drug quality supervision is an important component of social security system.
藥品質(zhì)量監(jiān)管是社會保障體系的一個重要組成部分。
The state adopts a protection system for certain traditional Chinese medicines.
國家實行中藥品種保護制度。
The drug monitoring is to be strengthened.
藥品監(jiān)管工作有待加強。
Furthermore, the incidents of counterfeit and low quality drugs occur from time to time, and there is an urgent need to strengthen the drug monitoring and intensify legislation and its implementation.
此外，社會上假劣藥品事件時有發(fā)生，迫切需要加強藥品監(jiān)管，加大執(zhí)法力度。
Doctor: Hi, Sam. You don't look very well. What seems to be the problem? My receptionist told me it was urgent.
醫(yī)生：嗨，山姆。你看起來好像不太舒服。怎么了？我的前臺告訴我你得了急病。
Sam: Help me, Doctor. I think I'm dying. Thanks for give me appointment so quickly.
山姆：幫幫我，醫(yī)生。我覺得我快死了，謝謝您能這么快約我。
Doctor: Let me see. I'll take temperature and blood pressure.
醫(yī)生：讓我看看你的體溫和血壓。
Sam: I've got a pounding headache, a dry throat.
山姆：我頭痛死了，喉嚨很干。
Doctor: Now let me have a look at you. I'd like to listen to your chest. Now breathe in a deep breath. That's it. Cough now again. I want to examine your throat too. Open wide say "Aaaaahh."
醫(yī)生：來，讓我瞧瞧你，聽聽你的胸腔?，F(xiàn)在深深地吸一口氣。對，就是這樣?？人砸幌?再咳一次。我還想再查查你的喉嚨。把嘴張開，說"啊--"。
Sam: Aaaaahh aaaaahh.
山姆：啊--啊--啊--啊。
Doctor: Are you getting enough sleep? Have you changed your diet lately?
醫(yī)生：你的睡眠正常嗎？你改變你的飲食了嗎？
Sam: I'm eating the same things I always eating. And I usually sleep eight hours a night.
山姆：我吃的東西一直是一樣的，而且每晚8個小時睡眠。
Doctor: When did this start? Have every felt this way before?
醫(yī)生：這種癥狀是從什么時候開始的？你以前像這樣發(fā)生過嗎？
Sam: I was exposed to the heavy rain after friend's party yesterday evening. I felt headache and sore throat after going back home.
山姆：昨天在朋友家開完派對淋了雨，回家后就覺得頭痛，喉嚨也不舒服。
Doctor: Have you ever had any medicines?
醫(yī)生：吃過藥嗎？
Sam: I bought some medicines in the drug store near home, but useless.
山姆：在離家不遠的小藥店買了點感冒藥，不過沒有什么作用。
Doctor: There are many unqualified medicine without drug quality inspection.
醫(yī)生：現(xiàn)在的很多藥都沒有經(jīng)過藥品質(zhì)量驗證，是不合格的藥。
Sam: Is there any consequences after taking these medicine?
山姆：吃了這些藥會有什么后果呢？
Sam: Useless is the better one, some of them even have severe side effects.
醫(yī)生：輕者不起作用，有的甚至還會產(chǎn)生嚴重的副作用。
Doctor: Our government should reinforce the drug quality control.
山姆：國家應(yīng)該加強藥品質(zhì)量監(jiān)管。
Doctor: It is important to go to the doctor when feel sick. The medicines prescribed by doctors are inspected by the quality standards, which are safe and effective.
醫(yī)生：生病就要及時來醫(yī)院就醫(yī)，醫(yī)院的藥品都是經(jīng)過質(zhì)量檢驗的，安全有效。
Sam: I know.
山姆：明白了。
Doctor: This is your prescription, you'll be better after some rest.
醫(yī)生：這是你的藥方，吃過藥后休息幾天就沒事了。
Sam: Thanks a lot!
山姆：謝謝醫(yī)生!
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