对于已有国家标准的药品，可只检测系统适用性试验。
As for national standard drugs, system suitability shall be tested only.
申请已有国家标准的药品注册，一般不需要进行临床研究。
Generally, it is not necessary to conduct clinical study for the application for registration of drugs with existing state standards.
已有国家标准药品的申请，是指生产已经由国家药品监督管理局颁布的正式标准的药品注册申请。
Application for drugs with existing state standards shall refer to the application for registration of the drugs for which the SDA has promulgated official standards.
在内容上编排成一个简明且符合实际的16步核对表，以对选择和购买安全有效且达到国际质量标准的药品提供指导。
The content is presented as a practical and concise 16-step practical checklist to guide the selection and procurement of safe and effective medicines meeting international quality standards.
也就是：对市场上的药品进行严格管控，严格执行质量标准，以及细致开展药物警戒。
That is: strict regulatory control of medicines on the market, strict enforcement of quality standards, and diligent pharmacovigilance.
世卫组织推动使用仿制药品，反对为符合世卫组织标准的仿制产品的生产和国际贸易设置障碍。
WHO promotes generic medicines and opposes barriers to the production and international trade of generic products that meet WHO standards.
美国人很愿意就医疗器械的标准达成一个协议，然后推敲出不同的合同，用以涵盖--比如说--电子产品和药品的生产。
The Americans would happily reach one accord on standards for medical devices and them hammer out different pacts covering, say, electronic goods and drug manufacturing.
美国环境保护署(EPA)在2009年9月曾表示，它正在考虑制定104种新增化学物质在自来水中的安全标准，包括杀虫剂、日用品、消毒副产品，并首次把药品纳入考虑范围。
EPA in September said it was considering regulating 104 additional chemicals in tap water, including pesticides, commercial chemicals, disinfection byproducts, and for the first time, pharmaceuticals.
这些始于1977年的标准清单有助于我们将药品作为一个整体来关注其重点。
These model lists, which date back to 1977, help focus priorities for the pharmaceutical sector as a whole.
这些标准应用于内部系统和外部实体(比如美国食品与药品安全管理局)之间的通信。
These standards apply to communication between internal systems and external entities, such as the U.S. Food and Drug Administration.
如果提交的数据完整并可证明产品达到规定的各项标准，世卫组织的药品资格预审程序所需时间可仅为三个月。
The WHO prequalification of medicines process can take as little as three months, provided the data presented are complete and demonstrate that the product meets all required standards.
世卫组织药品资格预审规划确保采购机构供应的药品符合可接受的质量、安全性和疗效标准。
The WHO Prequalification of medicines Programme (PQP) ensures that medicines supplied by procurement agencies meet acceptable standards of quality, safety and efficacy.
我们会毫不犹豫地让掉发霉的或滋满细菌的食物，我们也应该以同样的标准对待用在我们皮肤上的洗涤剂和药品。
We wouldn't hesitate to chuck out mouldy or bacteria-ridden food and the same standards should apply to the lotions and potions and that we put on our skin.
作者在文章写得，研究的目标是要应用在多标准的决策分析模型中，重新评估英国的药品危害。
The authors write that their goal was to apply multi-criteria decision analysis modelling to re-evaluate drug harms in the U.
使儿童疾病综合管理的临床标准指导原则适应本国的需求、可获得的药品、政策，以及当地人口食用的食物和使用的语言。
Adapting the standard IMCI clinical guidelines to the country's needs, available drugs, policies, and to the local foods and language used by the population.
委员会还确定了15 个新的参比制剂，采用全球计量标准，以指导生产厂商和药品监督管理部门开展生物药品工作。
The committee also established 15 new reference preparations, which are global measurement standards that guide manufacturers and regulatory authorities on the activity of biological medicines.
对药品来说，风险要与好处对比进行权衡；而对食品而言，不管有什么样的好处，都有统一的安全标准。
With medicines, risks are weighed against their benefits; with food, there are uniform safety standards, regardless of benefits.
为防止食源性疾病的爆发，食品和药品管理局将向生产果蔬的农场设立标准，而不是去检查它们。
The FDA also will have to set standards for farms that produce fruits and vegetables, with the goal of preventing outbreaks of food-borne illness, rather than just detecting them.
美国食品与药品管理局（FDA）规定，低脂肪食品必须符合每份食品中所含脂肪不多于3克的标准。
According to FDA rules, a product advertised as "low fat" must have 3 grams or less of fat per serving.
药品资格预审规划的活动以促进药品质量、安全性和疗效的国际药物标准为基础。
PQP bases its activities on international pharmaceutical standards for medicines quality, safety and efficacy.
这种药品的费用大约为每月30美元。它使卫生部能够开展一项大规模的运动，把这种三合一药品用于标准的ART治疗。
This has allowed the Ministry of Public Health (MOPH) to roll out a large-scale campaign to provide triple-drug ART as standard care.
WHO将提供有用的建议，并为那些过于贫穷以至于连医疗管理机构(类似于美国的FDA，食品药品监督管理局)都没有的国家，建立规范的卫生标准。
The agency provides useful advice and sets technical standards for countries too poor to have proper medical regulators like America's Food and Drug Administration.
但当SFDA试着要将其药品认证程序标准化时，一些人却担心以些小一点的公司将无法生存。
But as the SFDA tries to raise standards for its drug-approval processes, some are worried that smaller companies will not be able to survive.
放行检测计划，包括一份书面标准操作规程(SOP)，其中详细说明你们将用于检测每种药品的方法以及每种检测的可接受标准。
Release testing program, including a written standard operating procedure (SOP) detailing the test methods you will use to test each product and the acceptance criteria for each test.
你们的稳定性检测计划，包括每项检测的稳定性指示性方法和可接受标准以支持你们药品标示的存贮条件和有效期。
Your stability testing program, including stability-indicating methods and acceptance criteria for each test to support the labeled storage conditions and expiry dates for your products.
你们的稳定性检测计划，包括每项检测的稳定性指示性方法和可接受标准以支持你们药品标示的存贮条件和有效期。
Your stability testing program, including stability-indicating methods and acceptance criteria for each test to support the labeled storage conditions and expiry dates for your products.
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