准备欧盟注册的asmf的公开和保密部分
临床研究
比如3.2,公开和保密都要写,那公开部分和保密部分之间是互相补充关系,还是保密部分包含所有内容,然后公开部分摘取保密的3.2文件里的需要提供给制剂客户的一些信息啊?
2022-08-23 15:52 灯下夜读     
2个回答

1)3.2在问题中我理解是3.2.S。

2)在EMA指南Guideline on Active Substance Master File Procedure中对AP和RP的内容做了个概述,如下:

The AP contains the information that the ASMF holder regards as non-confidential to the Applicant/MA holder, whereas the RP contains the information that the ASMF holder regards as confidential, see Annex 1. .........

It is emphasized that the AP is still a confidential document that cannot be submitted by anyone to third parties without the written consent of the ASMF holder. In all cases the AP should contain sufficient information to enable the Applicant/MA holder to take full responsibility for an evaluation of the suitability of the specification for the active substance to control the quality of this active substance for use in the manufacture of a specified medicinal product.
The RP may contain the remaining information, such as detailed information on the individual steps of the manufacturing method (reaction conditions, temperature, validation and evaluation data of critical steps) and the quality control during the manufacture of the active substance. 

3)另在Annex 1 中对AP和RP部分内容作了指引,根据Annex 1提供即可,如下:


a) Flow chart and short description is regarded as sufficient, if detailed information is presented in the Restricted Part. However, full validation data on the sterilisation process may be requested in the Applicant’s Part (in cases where there is no further sterilisation of the final product).
b) Detailed information.
c) As far as the information is also relevant for the Applicant/MA holder.
d) As far as the information is related to the detailed description of the manufacturing process and as far as this information is not relevant for the Applicant/MA holder.
e) In so far as the information is related to the detailed description of the manufacturing process and in so far as the ASMF holder sufficiently justifies that there is no need to control these impurities in the final active substance.
f) As far as the information is related to the detailed description of the manufacturing process, control of materials and process validation.


4)需要注意的是:

a) AP部分的内容除了保密部分也需要提供的章节,即32s2、32、45外,其他章节应是完整内容。

b) 对于AP和RP都需要提供的内容,RP部分应为完整内容,AP部分对应内容考虑到ASMP holder利益,可摘取概要内容,但相关信息应以满足制剂上市审评需求。

c) RP部分主要和制备工艺相关,通常32s32/45 RP部分是根保密需求提供,如无需,可仅为AP内容。

5)根据Annex 1提供了RP部分完整内容后,如无法把握AP对应内容详实程度,也不用过于纠结。如所提供信息不足以支持制剂上市审评需求,官方审评时会指出(以缺陷项的形式),把对应信息补充到AP部分即可,这种缺陷相对是很良性的缺陷,很好解决。

6)2.3.s同3.2.s。


以上信息供参考,希望对你有帮助。

2022-08-28 12:22 Yiran     

根据我们的经验,公开部分和保密部分是互相补充的,即公开部分是3.2.S.1、3.2.S.2.1、3.2.S.3、3.2.S.4、3.2.S.5、3.2.S.6和3.2.S.7,保密部分是3.2.S.2,这样公开部分不包含生产信息,但是包含杂质分析等内容,可以提供给制剂客户,用于制剂的相关分析。而保密部分可以直接提供给欧盟当局,用于当局对申报资料的整体评估,有问题会提出补充或修改。

2022-09-05 15:49 Lumiya