【正文】 nical trial conducted by an institution not yet certified for drug clinical trials may be submitted along with the application for drug 21The investigator responsible for a drug clinical trial shall, in accordance with the relevant provisions, timely report adverse events occurred in the process of the clinical trial to the State Food and Drug no adverse eventoccurs, the investigator shall collect relevant information and report to the State Food and Drug Administration 22The State Food and Drug Administration shall, in accordance with law, supervise and inspect the clinical trials of drugs for public health 6 Review, Approval and Monitoring of Drug ProductionArticle 23The applicant shall, after pletion of the drug clinical trials, submit the relevant data to the State Food and Drug Administration in accordance with the Provisions for Drug 24The State Food and Drug Administration shall, within 24 hours after receiving data submitted by the applicant, organize technical review, and at the same time notify the(food and)drug regulatory department of the province, autonomous region, or municipality directly under the Central Government where the applicant is located to conduct the onsite inspection on the drug manufacturing conditions, andorganize the sampling and testing of pilot (food and)drug regulatory department of the province, autonomous region, or municipality directly under the Central Government shall, within five days, submit the result and opinion of the onsite inspection to the State Food and Drug 25Any newlyestablished drug manufacturer or manufacturer with newlybuilt manufacturing workshops or newlyadded dosage forms for production may apply to the State Food and Drug Administration for a certificate of the Good Manufacturing Practice along with the application for drug State Food and Drug Administration shall, when conducting the drug registration review, immediately carry out an inspection on the Good Manufacturing Practice 26The drug testing institution shall, after receiving the samples of three batches taken by the(food and)drug regulatory department of the province, autonomous region, or municipality directly under the Central Government, immediately arrange the pletion of testing, the drug testing institution shall, within two days, plete the test report and submit it to the State Food and Drug 27The State Food and Drug Administration shall carry out technical review in accordance with Chapter 4 of the Procedure, and shall, within three days after the pletion of the technical review, plete the administrative examination, make a decision and inform the the State Food and Drug Administration decides to approve the drug, it shall issue the Letter of Approval for Drug Registration, and may grant an approval number for the drug at the same time if the applicant has appropriate manufacturingconditions。if it decides to disapprove the manufacturing, it shall issue a Disapproval Notice with 28Where a drug manufacturer or distributor, or a medical and healthinstitution finds any new or serious adverse drug reaction or cluster adverse reaction relating to a specially approved drug for public health emergencies, it shallimmediately report the case to the local(food and)drug regulatory department of the province, autonomous region, or municipality directly under the Central Government, the health administrative department at the provincial level and the professional institution for adverse drug reactions professional institution for adverse drug reactions monitoring shall regard drugs specially approved for public health emergencies as critically monitored products, analyze the collected case reports in accordance with the relevant provisions and timely report to the(food and)drug regulatory department of the province,autonomous region, or municipality directly under the Central Government and the State Food and Drug State Food and Drug Administration shall reinforce the reevaluation of approved drugs for public health emergencies after they are 7 Supplementary ProvisionsArticle 29The measures for special review and approval of the medical devices for public health emergencies shall be separately formulated by the State Food and Drug Administration with reference to the relevant provisions of the 30The Procedure shall go into effect as of the date of promulgation.第五篇：醫(yī)療器械生產(chǎn)企業(yè)許可證核發(fā)審批程序醫(yī)療器械生產(chǎn)企業(yè)許可證核發(fā)審批程序許可項(xiàng)目名稱：醫(yī)療器械生產(chǎn)企業(yè)許可證核發(fā)法定實(shí)施主體：江西省食品藥品監(jiān)督管理局許可依據(jù)：《醫(yī)療器械監(jiān)督管理?xiàng)l例》（中華人民共和國(guó)國(guó)務(wù)院令第276號(hào)）；《醫(yī)療器械生產(chǎn)監(jiān)督管理辦法》（國(guó)家食品藥品監(jiān)督管理局令第12號(hào)）；《醫(yī)療器械生產(chǎn)企業(yè)許可證》審批操作規(guī)范（國(guó)食藥監(jiān)械[2004]521號(hào)）；《一次性使用無菌醫(yī)療器械產(chǎn)品（注、輸器具）生產(chǎn)實(shí)施細(xì)則》（國(guó)藥監(jiān)械[2001]288號(hào)）；《一次性使用麻醉穿刺包生產(chǎn)實(shí)施細(xì)則》(國(guó)藥監(jiān)械[2002]472號(hào))；《體外診斷試劑生產(chǎn)實(shí)施細(xì)則（試行）》（國(guó)食藥監(jiān)械〔2007〕239號(hào)）。收費(fèi)標(biāo)準(zhǔn)：不收費(fèi)?？倳r(shí)限：申請(qǐng)開辦的，自受理完成之日起20個(gè)工作日（不含補(bǔ)正、公示、送達(dá)時(shí)間）受理4個(gè)工作日；技術(shù)審評(píng)10個(gè)工作日；審核2個(gè)工作日；復(fù)核2個(gè)工作日；核定2個(gè)工作日公示7天（不計(jì)入審批時(shí)限）審批2個(gè)工作日；制作行政許可決定2個(gè)工作日；送達(dá)3個(gè)工作日（不計(jì)入審批時(shí)限）。受理范圍：本行政區(qū)域內(nèi)第二、三類醫(yī)療器械生產(chǎn)企業(yè)許可審批申請(qǐng)由省局受理。許可程序一、申請(qǐng)與受理申報(bào)材料要求（申請(qǐng)材料一式一份）受理開辦企業(yè)申報(bào)材料需核對(duì)以下材料：⑴《醫(yī)療器械生產(chǎn)企業(yè)許可證》（開辦）申請(qǐng)表；⑵ 法定代表人、企業(yè)負(fù)責(zé)人的基本情況及資質(zhì)證明，包括身份證明，學(xué)歷證明，職稱證明； ⑶ 工商行政管理部門出具的企業(yè)名稱核準(zhǔn)通知書或營(yíng)業(yè)執(zhí)照原件和復(fù)印件；⑷ 生產(chǎn)場(chǎng)地證明文件，包括房產(chǎn)證明或租賃協(xié)議和被租賃方的房產(chǎn)證明的復(fù)印件，廠區(qū)總平面圖，主要生產(chǎn)車間布置圖。有潔凈要求的車間，須標(biāo)明功能間及人物流走向；⑸ 企業(yè)的生產(chǎn)、技術(shù)、質(zhì)量部門負(fù)責(zé)人簡(jiǎn)歷，學(xué)歷和職稱證書的復(fù)印件；相關(guān)專業(yè)技術(shù)人員、技術(shù)工人登記表、證書復(fù)印件，并標(biāo)明所在部門及崗位；高、中、初級(jí)技術(shù)人員的比例情況表；內(nèi)審員證書復(fù)印件；⑹ 擬生產(chǎn)產(chǎn)品范圍、品種和相關(guān)產(chǎn)品簡(jiǎn)介。產(chǎn)品簡(jiǎn)介至少包括對(duì)產(chǎn)品的結(jié)構(gòu)組成、原理、預(yù)期用途的說明及產(chǎn)品標(biāo)準(zhǔn)；⑺ 主要生產(chǎn)設(shè)備及檢驗(yàn)儀器清單；⑻ 生產(chǎn)質(zhì)量管理規(guī)范文件目錄：包括采購、驗(yàn)收、生產(chǎn)過程、產(chǎn)品檢驗(yàn)、入庫、出庫、質(zhì)量跟蹤、用戶反饋、不良事件監(jiān)測(cè)和質(zhì)量事故報(bào)告制度等文件、企業(yè)組織機(jī)構(gòu)圖；⑼ 擬生產(chǎn)產(chǎn)品的工藝流程圖，并注明主要控制項(xiàng)目和控制點(diǎn)。包括關(guān)鍵和特殊工序的設(shè)備、人員及工藝參數(shù)控制的說明；⑽ 擬生產(chǎn)無菌醫(yī)療器械(指生產(chǎn)環(huán)境有凈化級(jí)別要求的企業(yè))的，需提供潔凈室的合格檢測(cè)報(bào)告。由省級(jí)食品藥品監(jiān)督管理部門認(rèn)可的檢測(cè)機(jī)構(gòu)出具的一年內(nèi)的符合《無菌醫(yī)療器具生產(chǎn)管理規(guī)范》（YY0033）的合格檢驗(yàn)報(bào)告；⑾ 申請(qǐng)材料真實(shí)性的自我保證聲明。崗位責(zé)任人：省局行政受理服務(wù)中心受理人員崗位職責(zé)及權(quán)限：按照標(biāo)準(zhǔn)查驗(yàn)申請(qǐng)材料。對(duì)申請(qǐng)材料齊全、符合形式審查要求的，應(yīng)及時(shí)受理，填寫《受理通知書》，將《受理通知書》交與申請(qǐng)人作為受理憑證。對(duì)申請(qǐng)人提交的申請(qǐng)材料不齊全或者不符合形式審查要求的，受理人員應(yīng)當(dāng)當(dāng)場(chǎng)一次告知申請(qǐng)人補(bǔ)正有關(guān)材料，填寫《補(bǔ)正材料通知書》，注明已具備和需要補(bǔ)正的內(nèi)容。經(jīng)補(bǔ)正資料后符合形式審查要求的，應(yīng)及時(shí)受理，填寫《受理通知書》，將《受理通知書》交與申請(qǐng)人作為受理憑證；經(jīng)補(bǔ)正資料后仍不符合形式審查要求的，不予受理，填寫《不予受理通知書》并載明其理由，將《不予受理通知書》和全部申報(bào)資料一并退回申請(qǐng)人。對(duì)申請(qǐng)事項(xiàng)不屬于本部門職權(quán)范圍或該申請(qǐng)事項(xiàng)不需行政許可的，不予受理，填寫《不予受理通知書》，并告知所屬審查機(jī)關(guān)或不予受理的理由?！妒芾硗ㄖ獣?、《不予受理通知書》應(yīng)當(dāng)加蓋省局受理專用