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 8月18日，國務(wù)院發(fā)布《國務(wù)院關(guān)于改革藥品醫(yī)療器械審評審批制度的意見》，意見明確，提高藥品審批標(biāo)準(zhǔn)，將藥品分為新藥和仿制藥。將新藥由現(xiàn)行的“未曾在中國境內(nèi)上市銷售的藥品”調(diào)整為“未在中國境內(nèi)外上市銷售的藥品”。
意見明確，將藥品分為新藥和仿制藥。將新藥由現(xiàn)行的“未曾在中國境內(nèi)上市銷售的藥品”調(diào)整為“未在中國境內(nèi)外上市銷售的藥品”。根據(jù)物質(zhì)基礎(chǔ)的原創(chuàng)性和新穎性，將新藥分為創(chuàng)新藥和改良型新藥。將仿制藥由現(xiàn)行的“仿已有國家標(biāo)準(zhǔn)的藥品”調(diào)整為“仿與原研藥品質(zhì)量和療效一致的藥品”。
根據(jù)上述原則，調(diào)整藥品注冊分類。仿制藥審評審批要以原研藥品作為參比制劑，確保新批準(zhǔn)的仿制藥質(zhì)量和療效與原研藥品一致。對改革前受理的藥品注冊申請，繼續(xù)按照原規(guī)定進(jìn)行審評審批，在質(zhì)量一致性評價工作中逐步解決與原研藥品質(zhì)量和療效一致性問題；如企業(yè)自愿申請按與原研藥品質(zhì)量和療效一致的新標(biāo)準(zhǔn)審批，可以設(shè)立綠色通道，按新的藥品注冊申請收費標(biāo)準(zhǔn)收費，加快審評審批。上述改革在依照法定程序取得授權(quán)后，在化學(xué)藥品中進(jìn)行試點。
