【正文】 s and patients are prohibited from being used as evidence for drug advertising. 。 Drug advertisement shall be subject to approval by the drug regulatory agencies of the government of the province, autonomous region or municipality directly under the Central Government where the enterprise is located and an approval number of drug advertisement shall he issued. No one is permitted to release advertisement without the approval number. 品監(jiān)督管理部門共同指定的醫(yī)學(xué)、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(duì)象的廣告宣傳。 Specified marks shall be printed in the label of narcotic drugs, psychotropic substances, toxic drugs for medical use, radioactive pharmaceuticals, 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。 Those who suffer from infectious diseases or any other diseases that may cause drug contamination are not permitted to undertake any job in direct contact 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。 Other cases where the drug standards are not plied with. 稱。 （三）超過有效期的； It is beyond the date of expiry。 The indications or functions indicated are beyond the specified scope. 85. 禁止生產(chǎn)、銷售劣藥。 （三）變質(zhì)的； It is deteriorated。 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。 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(cè)證書。 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(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。 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 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(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。 The pharmaceutical preparations to be dispensed by the medical institution shall be those satisfying the clinic need of the institution but not available on the market. It shall be subject to approval in advance by the local drug regulatory agency of the government of the province, autonomous region or municipality directly under the Central Government. ，不得在市場(chǎng)銷售。 No drugs other than the Chinese crude drugs may be sold at fairs in urban and rural areas, but drug retailers holding the Drug Supply Certificate may, within the specified business scope, sell such drugs at the stores they set up 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》。 Drug distributors shall indicate the habitat of Chinese crude drugs to be sold. ，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。 After receiving the drug purchased, drug distributors shall pass the established examination and acceptance system, and check the certificate of drug quality, labels and others marks。(3) having the quality control units or personnel adaptable the drugs to be distributed。 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。 No products that do not meet the National Drug Standards or that are not produced according to the processing procedures for the prepared slices of Chinese crude drugs formulated by the drug regulatory agency of the government of a province, autonomous region, or municipality directly under the Central Government may be released. 督管理部門授權(quán)的省、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。 With the exception of the processing of prepared slices of Chinese crude drugs, a drug shall be produced in conformity with the National Drug Standard and with the production processes approved by the drug regulatory agency of the State Council, and the production records shall be plete and accurate. 的，必須報(bào)原批準(zhǔn)部門審核批準(zhǔn)。 (3) having quality management and control units and personnel capable of quality management of and testing for drugs to be produced and the necessary instruments and equipment。 The term of validation and the scope of manufacturing shall be noted in the Drug Manufacturing Certificate. For renewal of the certificate on expiration, 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)。 The drug regulatory agency of the State Council shall be responsible for drug 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。 1 常 用 藥 品 監(jiān) 管 英 語 與 縮 略 語 —— 浙江省藥品監(jiān)督管理局政策法規(guī)處 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。s republic of China. 品監(jiān)督管 2 理工作。 Any newly established pharmaceutical manufacturer shall be subject to approval by the local drug regulatory agency of the government of the province, autonomous region or municipality directly under the Central Government and be granted the Drug Manufacturing Certificate, and, with the certificate, the manufacturer shall be registered with the administrative agency 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。(2) provided with the premises, facilities, and clear environment required for drug manufacturing。 Drug manufacturers shall conduct production according to the Good Manufacturing Practice Products (GMP) formulated by the drug regulatory agency of the State Council based on this Law.