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（續(xù)） 3. General principles The comparator product is defined as a pharmaceutical product with which the multisource product is intended to be interchangeable in clinical practice. 3、一般原則 參比制劑被定義為多源藥品試圖在臨床實踐中可互換的藥品。 As a general principle, multisource products should comply with the same standards of quality, safety and efficacy as are applicable to the corresponding comparator product. In addition, quality attributes of a multisource product should be tested against the comparator product with which it should be interchangeable. 一般原則是，多源藥品應(yīng)符合與其參比制劑相同的質(zhì)量、安全性和有效性標準。此外，多源藥品的質(zhì)量屬性應(yīng)該針對其試圖可互換的參比制劑進行測試。 The selection of the comparator pharmaceutical product is usually made at the national or regional level by the national or regional regulator... -
Annex 8 Guidance on the selection of comparator pharmaceutical products for equivalence assessment of interchangeable multisource (generic) products 1. Introduction 2. Background 3. General principles References 附件8 可互換多源藥品（仿制藥）等效性評價用參比制劑的選擇指導(dǎo)原則 1、引言 2、背景 3、一般原則 參考文獻 1. Introduction In recent years the need for the regulation and assurance of quality of medicines has continued to increase. Large numbers of multisource (generic) medicines are being produced by many different companies and in different countries; this may result in different products. On a global level there is thus a need to address not only the quality, safety and efficacy of multisource products that are exported and imported, but also their possible interchangeability. 1、引言 近年來，對藥品質(zhì)量監(jiān)管的要求不...
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新年伊始，還沒過正月，國家食品藥品監(jiān)督管理局又發(fā)布了一項公告：化學(xué)藥品注冊分類改革正式落地，開始實施了。 少不得簡單回顧歷史。 現(xiàn)在我們施行的化學(xué)藥品注冊分類是2007年頒發(fā)的《藥品注冊管理辦法》附件二，共分為6類；其中1~5類按新藥管理，6類為仿制藥；進口藥品單獨提出。 2015年11月，為落實《國務(wù)院關(guān)于改革藥品醫(yī)療器審評審批制度的意見》，是藥監(jiān)總局起草了《化學(xué)藥品注冊分類改革工作方案（征求意見稿）》，重新對化藥注冊進行分類。 2016年3月4日（又是周末啦），《化學(xué)藥品注冊分類改革工作方案》正式定稿開始實施。 現(xiàn)在，咱們就比較一下三個版本的注冊分類，看看都有哪些變化。 2007注冊管理辦法 2015征求意見 2016正式稿 分類 6類 5類 5類 大類 新藥，仿制藥，進口 創(chuàng)新藥，改良型新藥，仿制藥 創(chuàng)新藥，改良型新藥，仿制藥 5年 1 未在國內(nèi)外上市銷售的藥品 境內(nèi)外均未上市的創(chuàng)新藥 境內(nèi)外均未上市的創(chuàng)新藥 （1）通過合成或者半合成的方法制得的原料藥及其制劑； ...
