【正文】 ments and issue a certificate to the manufacturer passing theinspection.，藥品必須按照國家藥品標(biāo)準(zhǔn)和國務(wù)院藥品監(jiān)督管理部門批準(zhǔn)的生產(chǎn)工藝進(jìn)行生產(chǎn)，生產(chǎn)記錄必須完整準(zhǔn)確。Any newly established pharmaceutical manufacturer shall be subject toapproval by the local drug regulatory agency of the government of theprovince, autonomous region or municipality directly under the CentralGovernment and be granted the Drug Manufacturing Certificate, and, with thecertificate, the manufacturer shall be registered with the administrativeagency for industry and merce.35.《藥品生產(chǎn)許可證》應(yīng)當(dāng)標(biāo)明有效期和生產(chǎn)范圍，到期重新審查發(fā)證。常 用 藥 品 監(jiān) 管 英 語 與 縮 略 語 一、監(jiān)管英語1.《中華人民共和國藥品管理法》 Drug Control Law of the People39。 The term of validation and the scope of manufacturing shall be noted in theDrug Manufacturing Certificate. For renewal of the certificate onexpiration, reviewing and approval again is required.，應(yīng)當(dāng)符合國家制定的藥品行業(yè)發(fā)展規(guī)劃和產(chǎn)業(yè)政策，防止重復(fù)建設(shè)。 With the exception of the processing of prepared slices of Chinese crudedrugs, a drug shall be produced in conformity with the National DrugStandard and with the production processes approved by the drugregulatory agency of the State Council, and the production records shall beplete and accurate. ，必須報(bào)原批準(zhǔn)部門審核批準(zhǔn)。 No one is permitted to distribute drugs without the certificate.48.《藥品經(jīng)營許可證》應(yīng)當(dāng)標(biāo)明有效期和經(jīng)營范圍，到期重新審查發(fā)證。 After receiving the drug purchased, drug distributors shall pass theestablished examination and acceptance system, and check the certificate ofdrug quality, labels and others marks。 No drugs other than the Chinese crude drugs may be sold at fairs in urbanand rural areas, but drug retailers holding the Drug Supply Certificate may,within the specified business scope, sell such drugs at the stores they setup at the fairs.，須經(jīng)所在地省、自治區(qū)、直轄市人民政府衛(wèi)生行政部門審核同意，由省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門批準(zhǔn)，發(fā)給《醫(yī)療機(jī)構(gòu)制劑許可證》。 The institutions for nonclinical safety evaluation and study and forclinical study institutions shall respectively follow the Good LaboratoryPractice for NonClinical Laboratory Studies (GLP) and Good ClinicalPractice (GCP).，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(shí)施批準(zhǔn)文號管理的中藥材和中藥飲片除外。 The drug control institution affiliated to the drug regulatory agency of theState Council is responsible for standardizing the National Drug StandardSubstance and Reference Substance.、藥品經(jīng)營企業(yè)、醫(yī)療機(jī)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(shí)施批準(zhǔn)文號管理的中藥材除外。 Production (including dispensing) and distribution of counterfeit drugs areprohibited.，為假藥： A drug falling into the following categories is deemed as a counterfeitdrug:（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 theNational Drug Standards。 The indications or functions indicated are beyond the specified scope.85. 禁止生產(chǎn)、銷售劣藥。 Other cases where the drug standards are not plied with.。 Specified marks shall be printed in the label of narcotic drugs,psychotropic substances, toxic drugs for medical use, radioactivepharmaceuticals, drugs for topical use, and nonprescription drugs.、經(jīng)營企業(yè)和醫(yī)療機(jī)構(gòu)必須執(zhí)行政府定價(jià)、政府指導(dǎo)價(jià)，不得以任何形式擅自提高價(jià)格。 names or images of government agencies,medical or pharmaceutical research institutions, academic institutions, orexperts, scholars, physicians and patients are prohibited from being used asevidence for drug advertising.。The State has established and exercised the reporting system on adverse drugreaction (ADR).《藥品生產(chǎn)許可證》、《藥品經(jīng)營許可證》或者《醫(yī)療機(jī)構(gòu)制劑許可證》生產(chǎn)藥品、經(jīng)營藥品的，依法予以取締 Without Drug Manufacturing Certificate, Drug Supply Certificate orPharmaceutical Preparation Certificate for Medical Institution, themanufacturer or distributor of drug or medical institution shall be bannedto produce or distribute drugs.111.(1)生產(chǎn)、銷售假藥的，沒收違法生產(chǎn)、銷售的藥品和違法所得，并處違法生產(chǎn)、銷售藥品貨值金額二倍以上五倍以下的罰款；Where counterfeit drugs are produced or sold, the drugs illegally producedor sold and the illegal ine shall be confiscated, and a fine not lessthan two times but not more than five times the value of the said drugsshall be collected.(2)有藥品批準(zhǔn)證明文件的予以撤銷，并責(zé)令停產(chǎn)、停業(yè)整頓；The approval documents, if any, shall be withdrawn and an order shall begiven to suspend production or business operation for rectification.(3)情節(jié)嚴(yán)重的，吊銷《藥品生產(chǎn)許可證》、《藥品經(jīng)營許可證》或者《醫(yī)療機(jī)構(gòu)制劑許可證》；構(gòu)成犯罪的，依法追究刑事責(zé)任。The State shall carry out the policy of classification administration ofmedical devices.。The instruction for use, label and package of medical devices shall plywith relevant standards or provisions in China.，標(biāo)明產(chǎn)品注冊證書編號。Medical institutions shall not reuse medical devices labeled for singleuse, and shall destroy them after use with record, according to relevantprovisions of the state.。Only testing institutions accredited by the drug regulatory agency inconjunction with the quality and technical supervision agency of the StateCouncil may conduct medical device test.，并不得從事或者參與同檢測有關(guān)的醫(yī)療器械的研制、生產(chǎn)、經(jīng)營和技術(shù)咨詢等活動(dòng)。For the manufacturing of class I medical devices, it requires that theenterprise file a record with the drug regulatory agency of provinces,autonomous regions or municipalities directly under the Central Government.、第三類醫(yī)療器械生產(chǎn)企業(yè)， 應(yīng)當(dāng)經(jīng)省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門審查批準(zhǔn)，并發(fā)給《醫(yī)療器械生產(chǎn)企業(yè)許可證》。Class I medical devices shall be inspected, approved and issued aregistration certificate by the drug regulatory agency of the government ofthe municipalities with districts.，由省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門審查批準(zhǔn)，并發(fā)給產(chǎn)品生產(chǎn)注冊證書。 If a crime is constituted, criminal liabilities shall be investigated underthe law.，是指用于預(yù)防、治療、診斷人的疾病，有目的地調(diào)節(jié)人的生理機(jī)能并規(guī)定有適應(yīng)癥或者功能主治、用法和用量的物質(zhì)，包括中藥材、中藥飲片、中成藥、化學(xué)原料藥及其制劑、抗生素、生化藥品、放射性藥品、血清、疫苗、血液制品和診斷藥品等。 When people from drug regulatory agencies conduct supervision andinspection, they shall show their identification documents, and shall keepconfidential the technical and business secrets of the persons or theinstitutions under inspection that have been informed in the course ofsupervision and inspection.，可以對藥品質(zhì)量進(jìn)行