本文選題：藥品注冊(cè) + 審批意見(jiàn)�。� 參考：《中國(guó)藥房》2017年22期

【摘要】：目的:為藥品注冊(cè)申報(bào)提供參考。方法:收集2015年國(guó)家食品藥品監(jiān)督管理總局對(duì)廣東省申報(bào)藥品不予批準(zhǔn)的審批意見(jiàn),分析臨床試驗(yàn)和注冊(cè)生產(chǎn)兩個(gè)階段中藥品注冊(cè)申報(bào)存在的問(wèn)題,并根據(jù)相關(guān)的政策法規(guī)提出建議。結(jié)果與結(jié)論:化學(xué)藥申報(bào)臨床試驗(yàn)階段被退審的原因主要集中在已有進(jìn)口藥品注冊(cè)申請(qǐng)批準(zhǔn)或該新藥進(jìn)入監(jiān)測(cè)期;而藥學(xué)研究質(zhì)量缺陷,特別是雜質(zhì)、有關(guān)物質(zhì)研究不充分是申報(bào)臨床試驗(yàn)和申報(bào)生產(chǎn)中的主要問(wèn)題。針對(duì)臨床試驗(yàn)申報(bào),申請(qǐng)人應(yīng)適應(yīng)新的藥品注冊(cè)分類改革,加強(qiáng)原始創(chuàng)新藥物研制,生物制品開(kāi)發(fā)應(yīng)建立全面有效的生物制品評(píng)價(jià)體系,形成優(yōu)勢(shì)技術(shù)和產(chǎn)品;針對(duì)注冊(cè)生產(chǎn)申報(bào),相關(guān)部門或藥物生產(chǎn)企業(yè)應(yīng)加強(qiáng)對(duì)藥品劑型和規(guī)格設(shè)計(jì)的合理性評(píng)價(jià),仿制藥應(yīng)注重與原研藥品的一致性評(píng)價(jià)。除此之外,還可通過(guò)建立科學(xué)可行的雜質(zhì)、有關(guān)物質(zhì)研究方法,注重前瞻性生產(chǎn)工藝的放大研究等解決上述問(wèn)題。
[Abstract]:Objective: to provide reference for drug registration. Methods: to collect the opinions of the State Administration of Food and Drug Administration on the examination and approval of drug declaration in Guangdong Province in 2015, and analyze the problems existing in the two stages of clinical trial and registered production. And according to the relevant policies and regulations put forward suggestions. Results & conclusion: the reasons for the withdrawal of chemical drugs in clinical trials are mainly due to the application for registration of imported drugs or the entry of the new drug into the monitoring period, and the quality defects, especially impurities, in pharmaceutical research. Insufficient research on related substances is the main problem in clinical trials and production. According to the clinical trial application, the applicant should adapt to the new drug registration and classification reform, strengthen the original and innovative drug development, and establish a comprehensive and effective biological product evaluation system to form the superior technology and product. According to the registered production declaration, the relevant departments or drug manufacturing enterprises should strengthen the rational evaluation of drug formulation and specification design, and the generic drugs should pay attention to the consistency evaluation with the original drugs. In addition, the above problems can be solved by establishing scientific and feasible impurity, research methods of related substances, and paying attention to the study of prospective production process.
【作者單位】： 廣東省食品藥品監(jiān)督管理局審評(píng)認(rèn)證中心;
【基金】：廣東省食品藥品監(jiān)督管理局定向委托課題(No.許藥-2016-01)
【分類號(hào)】：R951

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本文編號(hào)：2054679