请问：世界卫生组织WHO的原料药预认证是否收费

汉中山茱萸

WHO在官方文件中说，保留为本次活动收取成本费用的权利。我想落实一下，到底有没有收过费？我公司计划申请这个认证，需要打听，谢谢诸位同仁。

kc1711422001

我也想知道 谁可以帮忙哩

汉中山茱萸

诸位同仁，急求。

wagamama

本来是完全免费的，2013年改成第一个产品不收费，具体说明如下，如需要原文PDF可以私信

First time applicants are exempt from application fees
Any manufacturer who has not previously had an application accepted for
assessment by PQP will be exempt from fees for their first application.
• A sliding scale fee structure
No application fees are charged for the first application for an EoI medicine and
reduced fees for second and third applications. Please note that this relates to
applications accepted for evaluation by PQP and not applications received by PQP.
• Reduced application fees for SRA approved products
Products that have been approved by a Stringent Regulatory Authority (SRA) will
attract a lower evaluation fee as PQP does not require, or assess, a full dossier. This
avoids duplication of regulatory effort and allows these products to be prequalified in
shorter timeframes, typically less than 4 months.
• Special circumstances
PQP will consider requests for fee waivers or reduced fees on a case-by-case basis.
For instance, a small manufacturer from a low-income nation may be able to make a
case that they should pay a reduced fee, or be exempt from fees.

beiwei5du

2013年9月1日以前是免费，后面是有相应的收费策略(资料显示18个月后会进行该收费方案的评估适用性，但是未在网络上查询到，而且文档是直接从WHO网站pre-qualification网站下载，应该没有什么变化。你可以按照该方案中的要求进行理解。
1、WHO预认证收费现阶段只针对于制剂和原料，不针对实验室；
2、第一次申请的申请人（是指通过初次筛选并进入评估才算“申请”，而不是初始递交阶段的申请），可以免除费用；
3、第一个EOI名单上的药品申请人（是指通过初次筛选并进入评估才算“申请”，而不是初始递交阶段的申请），可以免除费用，第二，三个申请人可以降低费用（具体费用见文件）；
4、对于通过SRA（具体名单可见附件）的申请人，可以降低费用；
5、其他一些特殊情况（附件中有个别提及，可参考）
6、针对于对已预认证的药品的重大变更需要进行缴费（具体重大变更的分类见http://www.who.int/prequal/info_ ... l2013_Variation.htm）；
7、费用缴纳实在进行初次筛选并被认为可以评估的阶段才进行缴费；

Stringent Drug Regulatory Authority (SRA) means a regulatory authority (in case of the European Union both EMEA and national competent authorities are included) which is (a) a member of the International Conference on Harmonization  of Technical Requirements for Registration of Pharmaceuticals for Human Use ICH (as specified on its website; or (b) an ICH Observer, being the European Free Trade Association (EFTA) as represented by SwissMedic, Health Canada and World Health Organization (WHO) (as may be updated from time to time); or (c) a regulatory authority associated with an ICH member through a legally binding mutual recognition agreement including Australia, Norway, Iceland and Liechtenstein (as may be updated from time to time).  

asia85008500

一句话，首个不收费