【正文】 　　nausea 惡心 　　vomit 嘔吐 常 用 藥 品 監(jiān) 管 英 語 與 縮 略 語s Republic of China control over drug distributors control over drugs control over drug price and advertisement legal liabilitiescounterfeit drugsdrug quality control laboratorydrug distributorsdrug regulatory agencyadministrative sanctionsGood Manufacturing Practice for Pharmaceutical Products (GMP)Drug Manufacturing CertificatePharmaceutical Preparation Certificate for Medical Institutionclinical trialDrug Approval Numbers Republic of China shall abide by drug control law of the people39。、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。，承擔(dān)依法實(shí)施藥品審批和藥品質(zhì)量監(jiān)督檢查所需的藥品檢驗(yàn)工作。，須經(jīng)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(zhǔn)并發(fā)給《藥品生產(chǎn)許可證》，憑《藥品生產(chǎn)許可證》到工商行政管理部門辦理登記注冊。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。，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)。，必須具備以下條件：（一）具有依法經(jīng)過資格認(rèn)定的藥學(xué)技術(shù)人員、工程技術(shù)人員及相應(yīng)的技術(shù)工人；（二）具有與其藥品生產(chǎn)相適應(yīng)的廠房、設(shè)施和衛(wèi)生環(huán)境；（三）具有能對所生產(chǎn)藥品進(jìn)行質(zhì)量管理和質(zhì)量檢驗(yàn)的機(jī)構(gòu)、人員以及必要的儀器設(shè)備；（四）具有保證藥品質(zhì)量的規(guī)章制度。(2) provided with the premises, facilities, and clear environment required for drug manufacturing。 and (4) establishing rules and regulations to govern the quality of drugs.藥品監(jiān)督管理部門按照規(guī)定對藥品生產(chǎn)企業(yè)是否符合《藥品生產(chǎn)質(zhì)量管理規(guī)范》的要求進(jìn)行認(rèn)證；對認(rèn)證合格的，發(fā)給認(rèn)證證書。，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。 Chinese crude drugs, a drug shall be produced in with National Drug Standard and the agency of the State Council, and the production records shall be plete and accurate. When drug manufacturers make any change in the production process that may affect the drug quality, they shall submit the change to the original authority for reviewing and approval.。、自治區(qū)、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。 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. A drug manufacturer may not accept any contract production of drugs unless it is approved by the drug regulatory agency of the State Council, or by the drug regulatory agency of the government of a province, autonomous region, or municipality directly under the Central Government authorized by the drug regulatory agency of the State Council.，須經(jīng)企業(yè)所在地縣級(jí)以上地方藥品監(jiān)督管理部門批準(zhǔn)并發(fā)給《藥品經(jīng)營許可證》。47. 藥品批發(fā)、零售企業(yè)憑《藥品經(jīng)營許可證》到工商行政管理部門辦理登記注冊?！端幤方?jīng)營許可證》的，不得經(jīng)營藥品。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。： （一）具有依法經(jīng)過資格認(rèn)定的藥學(xué)技術(shù)人員；（二）具有與所經(jīng)營藥品相適應(yīng)的營業(yè)場所、設(shè)備、倉儲(chǔ)設(shè)施、衛(wèi)生環(huán)境；（三）具有與所經(jīng)營藥品相適應(yīng)的質(zhì)量管理機(jī)構(gòu)或者人員；（四）具有保證所經(jīng)營藥品質(zhì)量的規(guī)章制度。(2) provided with the business operation premises, equipment, warehouses, and clear environment required for drug distribution。 and(4) establishing rules and regulations to govern the quality of the drugs to be distributed.Drug distributors shall conduct business according to the Good Supply Practice for Pharmaceutical Products (GSP) set by the drug regulatory agency of the State Council based on this Law. The drug regulatory agency inspect a drug distributor as to its pliance with the GSP requirements, and issue a certificate to the distributor passing the inspection. 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。，必須有真實(shí)完整的購銷記錄。、劑型、規(guī)格、批號(hào)、有效期、生產(chǎn)廠商、購（銷）貨單位、購（銷）貨數(shù)量、購銷價(jià)格、購（銷）貨日期及國務(wù)院藥品監(jiān)督管理部門規(guī)定的其他內(nèi)容。，必須標(biāo)明產(chǎn)地。，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。，國務(wù)院另有規(guī)定的除外。，但持有《藥品經(jīng)營許可證》的藥品零售企業(yè)在規(guī)定的范圍內(nèi)可以在城鄉(xiāng)集市貿(mào)易市場設(shè)點(diǎn)出售中藥材以外的藥品。，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》?！夺t(yī)療機(jī)構(gòu)制劑許可證》的醫(yī)療機(jī)構(gòu)，不得配制制劑。62.《醫(yī)療機(jī)構(gòu)制劑許可證》應(yīng)當(dāng)標(biāo)明有效期，到期重新審查發(fā)證。，應(yīng)當(dāng)是本單位臨床需要而市場上沒有供應(yīng)的品種，并須經(jīng)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(zhǔn)后方可配制。，不得在市場銷售。，必須按照國務(wù)院藥品監(jiān)督管理部門的規(guī)定如實(shí)報(bào)送研制方法、質(zhì)量指標(biāo)、藥理及毒理試驗(yàn)結(jié)果等有關(guān)資料和樣品，經(jīng)國務(wù)院藥品監(jiān)督管理部門批準(zhǔn)后，方可進(jìn)行臨床試驗(yàn)。，由國務(wù)院藥品監(jiān)督管理部門批準(zhǔn)，發(fā)給新藥證書。、藥物臨床試驗(yàn)質(zhì)量管理規(guī)范。，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。、中藥飲片品種目錄由國務(wù)院藥品監(jiān)督管理部門會(huì)同國務(wù)院中醫(yī)藥管理部門制定。，方可生產(chǎn)該藥品。71. 藥品必須符合國家藥品標(biāo)準(zhǔn)。《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)。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. The drug regulatory agency of the State Council shall organize a pharmacopoeia mission, which shall be responsible for formulating and revising the National Drug Standards. 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. 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.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. The State adopts a system of classified management for prescription and nonprescription drugs. Reviewing the drugs to be imported shall e of the jurisdiction of the drug regulatory agency of the State Council. A drug is 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. 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. Production (including dispensing) and distribution of counterfeit drugs are prohibited. （二）以非藥品冒充藥品或者以他種藥品冒充此種藥品的。，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