【正文】 ........................................................................4三、2022 年退審品種及其退審原因分析 .......................................................................................5（一） 、規(guī)格設(shè)計(jì)不符合要求 ......................................................................................................51．規(guī)格低于臨床單次用量 ......................................................................................................52．規(guī)格高于臨床最大劑量或濃度 ..........................................................................................73．主藥含量大于單次肌肉注射的給藥劑量且小于單次靜脈滴注的給藥劑量 ..................94．規(guī)格不在用藥范圍內(nèi) ..........................................................................................................95．規(guī)格為非常規(guī)裝量體積 ......................................................................................................96．申報(bào)規(guī)格依據(jù)體重可派生出無數(shù)規(guī)格 ............................................................................107．現(xiàn)有規(guī)格已滿足臨床需求 ................................................................................................118．申報(bào)規(guī)格不是最低規(guī)格的整數(shù)倍 ....................................................................................129．與已上市規(guī)格含量接近而無實(shí)際臨床意義 ....................................................................1210．規(guī)格的設(shè)計(jì)不符合有關(guān)通知要求 ..................................................................................1211．其它 ..................................................................................................................................14（二） 、未在規(guī)定時(shí)限補(bǔ)來資料 ................................................................................................16（三） 、申請(qǐng)人主動(dòng)撤回注冊(cè)申請(qǐng) ............................................................................................18（四） 、處于保護(hù)期 ....................................................................................................................241．新藥保護(hù)期 ........................................................................................................................242．新藥監(jiān)測(cè)期 ........................................................................................................................253．臨床公告品種 ....................................................................................................................254．行政保護(hù)期 ........................................................................................................................255．中藥保護(hù)期 ........................................................................................................................266．國家秘密技術(shù)項(xiàng)目 ............................................................................................................27（五） 、劑型設(shè)計(jì)不合理 ............................................................................................................271．與上市劑型不一致且立題依據(jù)不充分 ............................................................................272．患者順應(yīng)性差 ....................................................................................................................273．操作過程復(fù)雜 ....................................................................................................................284．劑型存在安全隱患 ............................................................................................................285．其它 ....................................................................................................................................28（六） 、檢定不合格 ....................................................................................................................29（七） 、不同意變更有效期 ........................................................................................................301．穩(wěn)定性試驗(yàn)不完善 ............................................................................................................302．質(zhì)量標(biāo)準(zhǔn)不完善 ................................................................................................................313．穩(wěn)定性資料和質(zhì)量標(biāo)準(zhǔn)均不完善 ....................................................................................31（八） 、不同意修改說明書 ........................................................................................................31（九） 、立題依據(jù)不充分 ............................................................................................................32（十） 、原料藥不符合要求 ........................................................................................................331．生產(chǎn)所用原料藥為已有批準(zhǔn)文號(hào)的原料藥 ....................................................................33SFDA 年終專題報(bào)告－2022 年退審品種及其退審原因分析報(bào)告512．原料藥來源于疫區(qū) ............................................................................................................333．其它 ....................................................................................................................................33（十一） 、申報(bào)資料不符合要求 ................................................................................................34（十二） 、工藝不合理 ................................................................................................................34（十三） 、鹽類藥物酸根不合理 ................................................................................................35（十四） 、存在臨床安全用藥隱患 ............................................................................................35（十五） 、生物等效性試驗(yàn)出現(xiàn)不等效現(xiàn)象 ............................................................................36（十六） 、不同意申報(bào)的適應(yīng)癥 ................................................................................................36（十七） 、輔料設(shè)計(jì)不合理 ........................................................................................................37（十八） 、不同意變更商品名 ....................................................................................................37（十九） 、不同意修改注冊(cè)標(biāo)準(zhǔn) ................................................................................................37（二十） 、不同意減免臨床 ........................................................................................................38（二十一） 、 臨床使用缺乏依據(jù) .........................................................................