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药品质量是指能满足规定要求的需要的特征总和。表现在以下五个方面：1.有效性；2.安全性；3.稳定性；4.均一性；5.经济性。药品质量标准：为保证药品质量而对各种检查项目、指标、限度、范围等所做的规定，称为药品质量标准。药品质量标准是药品的纯度、成分含量、组分、生物有效性、疗效、毒副作用、热原度、无菌度、物理化学性质以及杂质的综合表现。
药品监督管理是指国家授权的行政机关，依法对药品、药事组织、药事活动、药品信息进行管理和监督；另一方面也包括司法、检察机关和药事法人和非法人组织、自然人对管理药品的行政机关和公务员的监督。
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.
根据国家食品药品监管局（the State Food and Drug Administration，简称SFDA）发布的报告显示，国家药品不良反应监测中心（China's National Center）2010年收到了692,904份药品不良反应(adverse drug reaction，简称ADR）报告，报告数量相比2009年增长了8.4%。报告显示，我国药品安全风险主要集中在抗感染药（anti-infection drugs）和中药注射剂（traditional Chinese medicine treatments）。除了药物本身的作用，药物滥用（abuse of medication）也会引起不良反应。
The state should reinforce the supervision of drug quality.
国家应当加强对药品质量的监督管理。
What are the consequences of taking medicines without drug quality testing?
服用未经过药品质量检验的药品会产生怎样的后果？
The unqualified medicines will severely damage people's health.
不合格的药品会对身体健康造成严重损害。
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.
药品质量方面是独立于传统应用的部分，关于其必要的理化的、生物的和微生物的试验是不能缺少的。
Watching doctor and taking medicine are unavoidable in our lives.
看病吃药是人们的生活中不可避免的。
Drug quality control is essential for people's lives and health.
药品质量监管对于保证百姓生命健康是至关重要的。
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证书是由EDQM（欧洲药品质量管理局）颁发的，用以证明某个活性物质是根据欧洲药典的相关专论或TSE专论的要求来生产的。
The drug producer and distributor must strictly comply with pharmaceutical production and quality management standards.
药品生产商和销售商必须严格遵守药品生产和质量管理规范。
The drugs should comply with the National Drug Standards.
药品必须符合国家药品标准。
Drug quality supervision is an important component of social security system.
药品质量监管是社会保障体系的一个重要组成部分。
The state adopts a protection system for certain traditional Chinese medicines.
国家实行中药品种保护制度。
The drug monitoring is to be strengthened.
药品监管工作有待加强。
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，社会上假劣药品事件时有发生，迫切需要加强药品监管，加大执法力度。
Doctor: Hi, Sam. You don't look very well. What seems to be the problem? My receptionist told me it was urgent.
医生：嗨，山姆。你看起来好像不太舒服。怎么了？我的前台告诉我你得了急病。
Sam: Help me, Doctor. I think I'm dying. Thanks for give me appointment so quickly.
山姆：帮帮我，医生。我觉得我快死了，谢谢您能这么快约我。
Doctor: Let me see. I'll take temperature and blood pressure.
医生：让我看看你的体温和血压。
Sam: I've got a pounding headache, a dry throat.
山姆：我头痛死了，喉咙很干。
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.”
医生：来，让我瞧瞧你，听听你的胸腔。现在深深地吸一口气。对，就是这样。咳嗽一下.再咳一次。我还想再查查你的喉咙。把嘴张开，说“啊——”。
Sam: Aaaaahh aaaaahh.
山姆：啊——啊——啊——啊。
Doctor: Are you getting enough sleep? Have you changed your diet lately?
医生：你的睡眠正常吗？你改变你的饮食了吗？
Sam: I'm eating the same things I always eating. And I usually sleep eight hours a night.
山姆：我吃的东西一直是一样的，而且每晚8个小时睡眠。
Doctor: When did this start? Have every felt this way before?
医生：这种症状是从什么时候开始的？你以前像这样发生过吗？
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：昨天在朋友家开完派对淋了雨，回家后就觉得头痛，喉咙也不舒服。
Doctor: Have you ever had any medicines?
医生：吃过药吗？
Sam: I bought some medicines in the drug store near home, but useless.
山姆：在离家不远的小药店买了点感冒药，不过没有什么作用。
Doctor: There are many unqualified medicine without drug quality inspection.
医生：现在的很多药都没有经过药品质量验证，是不合格的药。
Sam: Is there any consequences after taking these medicine?
山姆：吃了这些药会有什么后果呢？
Sam: Useless is the better one, some of them even have severe side effects.
医生：轻者不起作用，有的甚至还会产生严重的副作用。
Doctor: Our government should reinforce the drug quality control.
山姆：国家应该加强药品质量监管。
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.
医生：生病就要及时来医院就医，医院的药品都是经过质量检验的，安全有效。
Sam: I know.
山姆：明白了。
Doctor: This is your prescription, you'll be better after some rest.
医生：这是你的药方，吃过药后休息几天就没事了。
Sam: Thanks a lot!
山姆：谢谢医生!