推薦產(chǎn)品
3-(4-chlorophenyl)-4-phenyl-4,5-dihydro-1H-pyrazole 2-(chloromethyl)-3-methylpyridinehydrochloride 1-(2-bromo-4-methylphenyl)ethanone 3-chloroisoquinoline-4-carbonitrile 5,8-dichloropyrido[3,2-d]pyridazine 2-bromomalononitrile 2-(4-(bromomethyl)phenyl)benzo[d]thiazole 1-(bromomethyl)-3-methoxy-2-nitrobenzene 6-bromo-1H-[1,2,3]triazolo[4,5-b]pyridine 4-iodo-2-((trimethylsilyloxy)methyl)thiazole 6-iodoimidazo[1,2-a]pyridine-3-carbonitrile 2-(4-chlorophenyl)-2-morpholinoacetonitrile 4-chloro-7H-pyrrolo[2,3-d]pyrimidine 4-chloroisothiazole 5-bromo-6-chloro-1H-indole 7-chloro-3H-imidazo[4,5-b]pyridine ethyl3-(4-formylphenyl)propanoate 2,3-dibromobenzaldehyde 1-(5H-chromeno[2,3-b]pyridin-7-yl)ethanone 5H-chromeno[2,3-b]pyridin-5-one 3-chloroisoquinoline-4-carbaldehyde (E)-2-(3-oxoprop-1-enyl)benzaldehyde methyl4-formyl-3-nitrobenzoate 5,6-dimethoxy-2,2-dimethyl-2,3-dihydro-1H-inden-1-one 1-methylbicyclo[4.1.0]heptan-3-one 3-nitro-4-(trifluoromethoxy)benzaldehyde 2-hydroxyquinoline-6-carbaldehyde 2-nitro-3-(trifluoromethyl)benzaldehyde 1-(2-fluoro-4-methoxyphenyl)propan-2-one tert-butyl3-fluoro-4-oxopiperidine-1-carboxylate tert-butyl3-oxopropylcarbamate 2,2-dimethylcyclohexanone 9H-carbazole-3-carbaldehyde N,N-dimethyl-2-oxoacetamide 2-methylpent-4-yn-2-ol 3-tert-butyl-4-hydroxybenzonitrile 4-bromo-2-tert-butylphenol 1,3-dibutoxypropan-2-ol methyl4-hydroxyquinoline-6-carboxylate methyl3-cyano-4-hydroxybenzoate 4-chloro-6-methoxyquinolin-7-ol 3,4-dihydro-2H-benzo[b][1,4]oxazin-7-ol 2-(2-aminothiazol-5-yl)ethanolhydrochloride (R)-ethyl2-chloropropanoate (S)-4-amino-5-(4,4-dimethylcyclohexylamino)-5-oxopentanoicacid (1s,4s)-4-hydroxycyclohexanecarboxylicacid (S)-2-(tetrahydrofuran-3-yloxy)aceticacid (1S,4R)-1-methyl-4-(prop-1-en-2-yl)cyclohex-2-enol (R)-4-(hydroxymethyl)oxazolidin-2-one (S)-4-(hydroxymethyl)oxazolidin-2-one 化工資訊 國(guó)家食藥監(jiān)總局(CFDA)官員在第27屆中國(guó)醫(yī)藥產(chǎn)業(yè)發(fā)展高峰論壇上介紹近期藥品監(jiān)管工作思路時(shí)指出，下一步將標(biāo)準(zhǔn)不降、時(shí)限不改地穩(wěn)步推行新版GMP認(rèn)證的實(shí)施工作，同時(shí)正在制定方案將藥品生產(chǎn)許可證和GMP證書(shū)合二為一。
他指出，根據(jù)新版GMP要求，非無(wú)菌類(lèi)別藥品應(yīng)在2015年12月31日前達(dá)到新版GMP要求，截至目前已經(jīng)有一半的企業(yè)通過(guò)認(rèn)證。“下一步會(huì)繼續(xù)推進(jìn)，標(biāo)準(zhǔn)不降、時(shí)限不改。”
他另表示，將逐步實(shí)施藥品生產(chǎn)許可證和藥品GMP證書(shū)合二為一。“具體方案正在制定，可能會(huì)取消GMP證書(shū)，變GMP認(rèn)證檢查為日常的監(jiān)督管理，對(duì)企業(yè)開(kāi)展動(dòng)態(tài)檢查。”
此外，該人士指出，無(wú)菌注射劑的質(zhì)量認(rèn)證在年底前或逐步下放到省級(jí)單位;取消中藥材GAP認(rèn)證，CFDA會(huì)積極研究中藥材認(rèn)證的監(jiān)督管理方式;生物制品批簽發(fā)技術(shù)性較強(qiáng)，暫時(shí)仍由國(guó)藥監(jiān)總局負(fù)責(zé)。
最后，他表示，擬將綜合檢驗(yàn)、檢測(cè)、檢查三項(xiàng)方面力量展開(kāi)整合，定期召開(kāi)風(fēng)險(xiǎn)研判會(huì)議，建立風(fēng)險(xiǎn)研判會(huì)議制度。“這個(gè)計(jì)劃正在實(shí)施當(dāng)中。”
