常用药品监管英语与缩略语doc28-医药保健(编辑修改稿)

常用药品监管英语与缩略语doc28-医药保健(编辑修改稿)内容摘要：

reviewing and approval. ，由国务院药品监督管理部门批准，发给新药证书。 When a new drug has gone through clinical trials and passed the reviewing, a New Drug Certificate shall be issued upon approval by the drug regulatory agency of the State Council. 机构必须分别执行药物非临床研 究质量管理规范、药物临床试验质量管理规范。 The institutions for nonclinical safety evaluation and study and for clinical study institutions shall respectively follow the Good Laboratory Practice for NonClinical Laboratory Studies (GLP) and Good Clinical 6 Practice (GCP). 产新药或者已有国家标准的药品的，须经国务院药品监督管理部门批准，并发给药品批准文号；但是，生产没有实施批准文号管理的中药材和中药饮片除外。 Production of a new drug or production of a drug plying with National Drug Standards shall be subject to the approval by the drug regulatory agency of the State Council, and a drug approval number shall be issued for it, with the exception of the Chinese crude drugs and the prepared slices of Chinese crude drugs in which no control by approval number is exercised. 、中药饮片品种目录由国务院药品监督管理部门会同国务院中医药管理部门制定。 The list of the Chinese crude drugs and the prepared slices of the Chinese crude drugs to be controlled by the approval number shall be piled by the drug regulatory agency of the State Council, jointly with the administrative agency for traditional Chinese medicines of the State Council. ，方可生产该药品。 A drug manufacturer is permitted to produce the drug only after an approval number has been granted to it. 71. 药品必须符合国家药品标准。 Drugs shall ply with the National Drug Standards. 《中华人民共和国药典》和药品标准为国家药品标准。 The Pharmacopoeia of the People39。 s Republic of China and the Drug Standards issued by the drug regulatory agency of the State Council shall serve as the National Drug Standards. ，负责国家药品标准的制定和修订。 The drug regulatory agency of the State Council shall anize a pharmacopoeia mission, which shall be responsible for formulating and revising the National Drug Standards. 标定国家药品标准品、对照品。 The drug control institution affiliated to the drug regulatory agency of the State Council is responsible for standardizing the National Drug Standard Substance and Reference Substance. 、药品经营企业、医疗机构必须从具有药品生产、经营资格的企业购进药品；但是，购进没有实施批准文号管理的中药材除外。 Drug manufacturers, drug distributors and medical institutions shall purchase drugs from pharmaceutical enterprises, which are qualified for production and distribution, with the exception of the Chinese crude drugs in which no control by approval number is exercised. 、精神药品、医疗用毒性药品、放射性药品，实行特殊管理。 The State exercises special control over narcotic drugs, psychotropic substances, toxic drugs for medical use and radioactive pharmaceuticals.。 The State adopts a protection system for certain traditional Chinese medicines. 度。 The State adopts a system of classified management for prescription and nonprescription drugs. ，须经国务院药品监督管理部门组织审查，经审查确认符合质量标准、安全有效的，方可批准进口，并发给进口药品注册证书。 Reviewing the drugs to be imported shall e of the jurisdiction of the drug regulatory agency of the State Council. A drug is 7 permitted to be imported only upon approval granted after confirming that it conforms to the quality, safely and efficiency through examination, and a drug importation license shall be issued.。 The State adopts a policy for drug storage for future use. 、疫情及其他突发事件时，国务院规定的部门可以紧急调用企业药品。 When major disasters, epidemic situations or other emergencies occur in the country, the department designated by the State Council may allocate drugs from the enterprises to meet the urgent need. 82. 禁止生产（包括配制）、销售假药。 Production (including dispensing) and distribution of counterfeit drugs are prohibited. ，为假药： A drug falling into the following categories is deemed as a counterfeit drug: （一）药品所含成份与国家药品标准规定的成份不符的； The ingredients in the drug are different from those specified by the National Drug Standards。 （二）以非药品冒充药品或者以他种药品冒充此种药品的。 It is not the same drug which is claimed by its name or in reality it is not a drug at all. ，按假药论处： A drug falling into the following categories shall be deemed as a counterfeit drug: （一）国务院药品监督管理部门规定禁止使用的； It’s use is prohibited by the provisions of the drug regulatory agency of the State Council。 （二）依照本法必须批准而未经批准生产、进口，或者依照本法必须检验而未经检验即销售的； It is produced or imported without approval, or marketed without being tested, as required by the Law。 （三）变质的； It is deteriorated。 （四）被污染的； It is contaminated。 （五）使用依照本法必须取得批准文号而未取得批准文号的原料药生产的； It is produced by using active pharmaceutical ingredients without approval number as required by this Law。 （六 ）所标明的适应症或者功能主治超出规定范围的。 The indications or functions indicated are beyond the specified scope. 85. 禁止生产、销售劣药。 Production and distribution of drugs of inferior quality are prohibited. ，为劣药。 A drug with content not up to the National Drug Standards is a drug of inferior quality. ，按劣药论处： A drug falling into the following categories shall be deemed as a drug of inferior quality: （一）未标明有效期或者更改有效期的； The date of expiry is not indicated or is altered。 （二）不注明或者更改生产批号的； The batch number is not indicated or is altered。 （三）超过有效期的； It is beyond the date of expiry。 （四）直接接触药品的包装材料和容器未经批准的； No approval certificate is obtained for the immediate packaging material or container。 （五）擅自添加着色剂、防腐剂、香料、矫味剂及辅料的； Colorants, preservatives, spices, flavorings, or other recipients have been added without 8 authorization。 or （六）其他不符合药品标准规定的。 Other cases where the drug standards are not plied with. 称。 已经作为药品通用名称的，该名称不得作为药品商标使用。 A drug name listed in the National Drug Standards is an adopted name in China. Such an adopted name is not permitted to be used as a trademark. 、药品经营企业和医疗机构直接接触药品的工作人员，必须每年进行健康检查。 Staff members of drug manufacturers, drug distributors and medical inst。