本文選題：藥品注冊 + 審批意見��； 參考：《中國藥房》2017年22期

【摘要】：目的:為藥品注冊申報提供參考。方法:收集2015年國家食品藥品監(jiān)督管理總局對廣東省申報藥品不予批準的審批意見,分析臨床試驗和注冊生產兩個階段中藥品注冊申報存在的問題,并根據相關的政策法規(guī)提出建議。結果與結論:化學藥申報臨床試驗階段被退審的原因主要集中在已有進口藥品注冊申請批準或該新藥進入監(jiān)測期;而藥學研究質量缺陷,特別是雜質、有關物質研究不充分是申報臨床試驗和申報生產中的主要問題。針對臨床試驗申報,申請人應適應新的藥品注冊分類改革,加強原始創(chuàng)新藥物研制,生物制品開發(fā)應建立全面有效的生物制品評價體系,形成優(yōu)勢技術和產品;針對注冊生產申報,相關部門或藥物生產企業(yè)應加強對藥品劑型和規(guī)格設計的合理性評價,仿制藥應注重與原研藥品的一致性評價。除此之外,還可通過建立科學可行的雜質、有關物質研究方法,注重前瞻性生產工藝的放大研究等解決上述問題。
[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)督管理局審評認證中心;
【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】：R951

【參考文獻】

相關期刊論文 前10條

1 姜艷春;;藥物制劑工藝開發(fā)與產業(yè)化研究[J];生物化工;2017年02期

2 趙懷全;;我國開展藥品上市許可持有人制度試點工作情況及相關政策建議[J];中國藥房;2017年04期

3 李小歡;徐昕s，

本文編號：2054679