【正文】 直轄市人民政府藥品監(jiān)督管理部門制定的中藥飲片炮制規(guī)范炮制的，不得出廠。 Drug manufacturers shall conduct production according to the GoodManufacturing Practice Products (GMP) formulated by the drug regulatoryagency of the State Council based on this Law. The drug regulatory agencyshall inspect a drug manufacturer as to its pliance with the GMPrequirements 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。(2) providedwith the premises, facilities, and clear environment required for drugmanufacturing。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。srepublic of China.。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 drug regulatory agency of the State Council shall be responsible fordrug administration and supervision nationwide. 、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門負(fù)責(zé)本行政區(qū)域內(nèi)的藥品監(jiān)督管理工作。 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)。 (3) having quality management and control units and personnelcapable of quality management of and testing for drugs to be produced andthe necessary instruments and equipment。 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 products that do not meet the National Drug Standards or that are notproduced according to the processing procedures for the prepared slices ofChinese crude drugs formulated by the drug regulatory agency of thegovernment of a province, autonomous region, or municipality directly underthe Central Government may be released.、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門批準(zhǔn)，藥品生產(chǎn)企業(yè)可以接受委托生產(chǎn)藥品。 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。(3) havingthe quality control units or personnel adaptable the drugs to bedistributed。 After receiving the drug purchased, drug distributors shall pass theestablished examination and acceptance system, and check the certificate ofdrug quality, labels and others marks。 Drug distributors shall indicate the habitat of Chinese crude drugs to besold.，采取必要的冷藏、防凍、防潮、防蟲、防鼠等措施，保證藥品質(zhì)量。 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 pharmaceutical preparations to be dispensed by the medical institutionshall be those satisfying the clinic need of the institution but notavailable on the market. It shall be subject to approval in advance by thelocal drug regulatory agency of the government of the province, autonomousregion or municipality directly under the Central Government.，不得在市場銷售。 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(hào)；但是，生產(chǎn)沒有實(shí)施批準(zhǔn)文號(hào)管理的中藥材和中藥飲片除外。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 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(hào)管理的中藥材除外。 The State adopts a system of classified management for prescription andnonprescription 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。 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。（三）變質(zhì)的； It is deteriorated。 The indications or functions indicated are beyond the specified scope.85. 禁止生產(chǎn)、銷售劣藥。（三）超過有效期的； It is beyond the date of expiry。 Other cases where the drug standards are not plied with.。 Those who suffer from infectious diseases or any other diseases that maycause drug contamination are not permitted to undertake any job in directcontact with drugs.91. 直接接觸藥品的包裝材料和容器，必須符合藥用要求，符合保障人體健康、安全的標(biāo)準(zhǔn)，并由藥品監(jiān)督管理部門在審批藥品時(shí)一并審批。 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。 Drug advertisement shall be subject to approval by the drug regulatoryagencies of the government of the province, autonomous region ormunicipality directly under the Central Government where the enterprise islocated and an approval number of drug advertisement shall he issued. No oneis permitted to release advertisement without the approval number.、藥學(xué)專業(yè)刊物上介紹，但不得在大眾傳播媒介發(fā)布廣告或者以其他方式進(jìn)行以公眾為對象的廣告宣傳。 names or images of government agencies,medical or pharmaceutical research institutions, academic institutions, orexperts, sc