【正文】 門規(guī)定禁止使用的； It’s use is prohibited by the provisions of the drug regulatory agency ofthe State Council。The State adopts a policy for drug storage for future use.、疫情及其他突發(fā)事件時，國務院規(guī)定的部門可以緊急調用企業(yè)藥品。The State exercises special control over narcotic drugs, psychotropicsubstances, toxic drugs for medical use and radioactive pharmaceuticals.。s Republic of China and the Drug Standardsissued by the drug regulatory agency of the State Council shall serve as theNational Drug Standards.，負責國家藥品標準的制定和修訂。The list of the Chinese crude drugs and the prepared slices of the Chinesecrude drugs to be controlled by the approval number shall be piled by thedrug regulatory agency of the State Council, jointly with the administrativeagency for traditional Chinese medicines of the State Council.，方可生產該藥品。A full description of a new drug research and development including themanufacturing process, quality specifications, results of pharmacologicaland toxicological study, and the related data as well as the samples shall,in accordance with the regulations of the drug regulatory agency of theState Council, be truthfully submitted to the above agency for reviewing andapproval.，由國務院藥品監(jiān)督管理部門批準，發(fā)給新藥證書。 No medical institution is permitted to dispense pharmaceutical preparationswithout the Pharmaceutical Preparation Certificate for Medical Institution.62.《醫(yī)療機構制劑許可證》應當標明有效期，到期重新審查發(fā)證。 An examination system shall be followed for storing drugs in warehouse andreleasing them from warehouse.，國務院另有規(guī)定的除外。Drug distributors shall keep a real and perfect records of purchasing andselling drugs.、劑型、規(guī)格、批號、有效期、生產廠商、購（銷）貨單位、購（銷）貨數量、購銷價格、購（銷）貨日期及國務院藥品監(jiān)督管理部門規(guī)定的其他內容。Drug distributors shall conduct business according to the Good SupplyPractice for Pharmaceutical Products (GSP) set by the drug regulatory agencyof the State Council based on this Law.《藥品經營質量管理規(guī)范》的要求進行認證；對認證合格的，發(fā)給認證證書。 A drug distributor to be established shall meet the followingrequirements:(1) staffed with legally qualified pharmaceuticalprofessionals。Any newly established drug retailer shall be subject to approval and begranted the above certificate by the local drug regulatory agency at orabove the county level.47. 藥品批發(fā)、零售企業(yè)憑《藥品經營許可證》到工商行政管理部門辦理登記注冊。 Active pharmaceutical ingredients (API) and recipients for the manufactureof pharmaceutical products shall meet the requirements for medicinal use.。藥品監(jiān)督管理部門按照規(guī)定對藥品生產企業(yè)是否符合《藥品生產質量管理規(guī)范》的要求進行認證；對認證合格的，發(fā)給認證證書。 Any drug manufacturer to be established shall meet the followingrequirements: (1) stuffed with legally qualified pharmaceutical andengineering professionals and the necessary technical workers。 The drug quality control laboratories established or designated by drugregulatory agencies shall undertake the responsibility for drug testingrequired for conducting drug review and approval and controlling drugquality pursuant to the law.，須經企業(yè)所在地省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門批準并發(fā)給《藥品生產許可證》，憑《藥品生產許可證》到工商行政管理部門辦理登記注冊。s Republic of China shall abide by drug control law of the people39。s Republic of China control over drug manufacturers control over drug distributors control over medicines in medical institutions control over drugs control over drug packaging control over drug price and advertisement inspection of drugs legal liabilitieslabels or marks of the drugscounterfeit drugsinferior drugsdrug quality control laboratorydrug manufacturersdrug distributorsmedical institutionsdrug regulatory agencydrug approval documentsadministrative sanctionscriminal liabilities Good Manufacturing Practice for Pharmaceutical Products (GMP)Good Supply Practice for Pharmaceutical Products (GSP)Drug Manufacturing CertificateDrug Supply CertificatePharmaceutical Preparation Certificate for Medical InstitutionImport Drug Licenseclinical trialNew Drug CertificateDrug Approval Number、生產、經營、使用和監(jiān)督管理的單位或者個人，必須遵守《中華人民共和國藥品管理法》 All institutions or individuals engaged in research, production,distribution, use, and administration and supervision of drugs in thePeople39。 The drug regulatory agencies of the governments of provinces, autonomousregions, and municipalities directly under the Central Government shall beresponsible for drug regulation in their administrative areas. ，承擔依法實施藥品審批和藥品質量監(jiān)督檢查所需的藥品檢驗工作。 When giving approval to the newlyestablished manufacturer, the drugregulatory agency shall see to it that the development programs and policiesset by the State for the pharmaceutical industry shall be plied with soas to prevent duplicate construction.，必須具備以下條件：（一）具有依法經過資格認定的藥學技術人員、工程技術人員及相應的技術工人；（二）具有與其藥品生產相適應的廠房、設施和衛(wèi)生環(huán)境；（三）具有能對所生產藥品進行質量管理和質量檢驗的機構、人員以及必要的儀器設備；（四）具有保證藥品質量的規(guī)章制度。 and (4) establishing rules andregulations to govern the quality of drugs.《藥品生產質量管理規(guī)范》組織生產。When drug manufacturers make any change in the production process that mayaffect the drug quality, they shall submit the change to the originalauthority for reviewing and approval.、輔料，必須符合藥用要求。 A drug manufacturer may not accept any contract production of drugs unlessit is approved by the drug regulatory agency of the State Council, or by thedrug regulatory agency of the government of a province, autonomous region,or municipality directly under the Central Government authorized by the drugregulatory agency of the State Council.，須經企業(yè)所在地省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門批準并發(fā)給《藥品經營許可證》.Any newly established drug wholesaler shall be subject to approval of thelocal drug agency of the government of the province, autonomous region ormunicipality directly under the Central Government and be granted the DrugSupply Certificate.，須經企業(yè)所在地縣級以上地方藥品監(jiān)督管理部門批準并發(fā)給《藥品經營許可證》。 The valid period and the scope of business shall be indicated in the Drug