【文章內(nèi)容簡介】 reviewing and approval. ，由國務(wù)院藥品監(jiān)督管理部門批準(zhǔn)，發(fā)給新藥證書。 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. 機構(gòu)必須分別執(zhí)行藥物非臨床研 究質(zhì)量管理規(guī)范、藥物臨床試驗質(zhì)量管理規(guī)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). 產(chǎn)新藥或者已有國家標(biāo)準(zhǔn)的藥品的，須經(jīng)國務(wù)院藥品監(jiān)督管理部門批準(zhǔn)，并發(fā)給藥品批準(zhǔn)文號；但是，生產(chǎn)沒有實施批準(zhǔn)文號管理的中藥材和中藥飲片除外。 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. 、中藥飲片品種目錄由國務(wù)院藥品監(jiān)督管理部門會同國務(wù)院中醫(yī)藥管理部門制定。 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. ，方可生產(chǎn)該藥品。 A drug manufacturer is permitted to produce the drug only after an approval number has been granted to it. 71. 藥品必須符合國家藥品標(biāo)準(zhǔn)。 Drugs shall ply with the National Drug Standards. 《中華人民共和國藥典》和藥品標(biāo)準(zhǔn)為國家藥品標(biāo)準(zhǔn)。 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. ，負(fù)責(zé)國家藥品標(biāo)準(zhǔn)的制定和修訂。 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. 標(biāo)定國家藥品標(biāo)準(zhǔn)品、對照品。 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. 、藥品經(jīng)營企業(yè)、醫(yī)療機構(gòu)必須從具有藥品生產(chǎn)、經(jīng)營資格的企業(yè)購進(jìn)藥品；但是，購進(jìn)沒有實施批準(zhǔn)文號管理的中藥材除外。 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. 、精神藥品、醫(yī)療用毒性藥品、放射性藥品，實行特殊管理。 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. ，須經(jīng)國務(wù)院藥品監(jiān)督管理部門組織審查，經(jīng)審查確認(rèn)符合質(zhì)量標(biāo)準(zhǔn)、安全有效的，方可批準(zhǔn)進(jìn)口，并發(fā)給進(jìn)口藥品注冊證書。 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. 、疫情及其他突發(fā)事件時，國務(wù)院規(guī)定的部門可以緊急調(diào)用企業(yè)藥品。 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. 禁止生產(chǎn)（包括配制）、銷售假藥。 Production (including dispensing) and distribution of counterfeit drugs are prohibited. ，為假藥： A drug falling into the following categories is deemed as a counterfeit drug: （一）藥品所含成份與國家藥品標(biāo)準(zhǔn)規(guī)定的成份不符的； The ingredients in the drug are different from those specified by the National Drug Standards。 （二）以非藥品冒充藥品或者以他種藥品冒充此種藥品的。 It is not the same drug which is claimed by its name or in reality it is not a drug at all. ，按假藥論處： A drug falling into the following categories shall be deemed as a counterfeit drug: （一）國務(wù)院藥品監(jiān)督管理部門規(guī)定禁止使用的； It’s use is prohibited by the provisions of the drug regulatory agency of the State Council。 （二）依照本法必須批準(zhǔn)而未經(jīng)批準(zhǔn)生產(chǎn)、進(jìn)口，或者依照本法必須檢驗而未經(jīng)檢驗即銷售的； It is produced or imported without approval, or marketed without being tested, as required by the Law。 （三）變質(zhì)的； It is deteriorated。 （四）被污染的； It is contaminated。 （五）使用依照本法必須取得批準(zhǔn)文號而未取得批準(zhǔn)文號的原料藥生產(chǎn)的； It is produced by using active pharmaceutical ingredients without approval number as required by this Law。 （六 ）所標(biāo)明的適應(yīng)癥或者功能主治超出規(guī)定范圍的。 The indications or functions indicated are beyond the specified scope. 85. 禁止生產(chǎn)、銷售劣藥。 Production and distribution of drugs of inferior quality are prohibited. ，為劣藥。 A drug with content not up to the National Drug Standards is a drug of inferior quality. ，按劣藥論處： A drug falling into the following categories shall be deemed as a drug of inferior quality: （一）未標(biāo)明有效期或者更改有效期的； The date of expiry is not indicated or is altered。 （二）不注明或者更改生產(chǎn)批號的； The batch number is not indicated or is altered。 （三）超過有效期的； It is beyond the date of expiry。 （四）直接接觸藥品的包裝材料和容器未經(jīng)批準(zhǔn)的； No approval certificate is obtained for the immediate packaging material or container。 （五）擅自添加著色劑、防腐劑、香料、矯味劑及輔料的； Colorants, preservatives, spices, flavorings, or other recipients have been added without 8 authorization。 or （六）其他不符合藥品標(biāo)準(zhǔn)規(guī)定的。 Other cases where the drug standards are not plied with. 稱。已經(jīng)作為藥品通用名稱的，該名稱不得作為藥品商標(biāo)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. 、藥品經(jīng)營企業(yè)和醫(yī)療機構(gòu)直接接觸藥品的工作人員，必須每年進(jìn)行健康檢查。 Staff members of drug manufacturers, drug distributors and medical inst