EMA：新活性物质确认考虑事项

julia朱玉姣

GMP News
27/01/2016

When can a Chemical Substance be qualified asa "New Active Substance"? The New Reflection Paper of the EMA givesInformation

一个化学物质怎样就能被作为是一个“新的活性物质”？EMA新的概念文章给出信息

Achemical structure with a therapeutic moiety for which no authorisationdossier has been submitted so far and which is - from a chemical structurepoint of view - not related to any other authorised substances is per se a"NAS" (New Active Substance). But what about aphysiologically active molecule present for example in different salts oresters? In which cases do the different derivatives of an effective substancehave the NAS status?

具有治疗部分的一个化学结构，还没有许可文档被提交时，从一个化学结构的角度来看，与其它任何被批准的物质均无关，其本质是一个“NAS（新的活性物质）”。但是，如果是一个生理活性分子，如，以不同的盐或酯形式出现呢？什么情况下一个有效物质的不同衍生物具有NAS状态？

TheEMA provides clarification to these questions in a new Reflection Paper whichwas published on 19 January this year. The document entitled  "Reflection paper on the chemical structure and propertiescriteria to be considered for the evaluation of new active substance (NAS)status of chemical substances" describes the criteria according towhich isomers, mixtures of isomers, complexes, derivatives, esters, ethers,salts and other solid forms of  physiologically active molecules can beclassified as "NAS ". If an applicant claims the NAS status of asubstance to the regulatory authority in the centralised (CP) ordecentralised procedure (MRP/DCP), the authority will first check whether theclaim is justified. Afterwards - in case of a positive decision - theusual review of the application dossier will be performed.

EMA对此问题在一份新的概念文章里进行了澄清，该文章被在本年1月19日被公布。文件题为“一个化学物质的新活性物质（NAS）状态评估时要考虑的化学结构和特性标准”，其中描述了标准，据此标准，异构体、异构体混合物、复合物、衍生物、酯、醚、盐和其它生理活性分子的固体形式都可以被分类作为“NAS”。如果一个申报人在集中审评（CP）或非集中程序（MRP/DCP）中向法规当局声称一个物质的NAS状态，当局会首先检查该声明是否经过了论证。然后---如果结果是好的结果，则需要对申报文档进行常规审核。

Theapplicant can refer to the criteria described in this Reflection Paper tosubstantiate his/ her claim of a NAS status. In general, the evidence has to bebrought for the derivative in question that it differs significantly  inproperties with regard to efficacy and /or safety from the already approvedactive substance.

申报人可以引用此概念文章中所述的标准，以支持其NAS状态。一般来说，证据必须证明所指的衍生物在特性方面、有效性和/或安全性方面与已批准的活性物质有显著差异。

Thescope of this Reflection Papers covers neither biological and biotechnologicalactive substances nor active substances to be included in radiopharmaceuticals.

本概念文章的范围包括生物制品和生物技术活性物质，以及它在辐射类，以及辐射药品所用的活性物质。

野性之吻

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chhlin1

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syhorchid

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