ECA新闻：日本和欧盟将扩展其MRA

蒲公英Ouryao · 公众号 · 医学 · 2017-07-31 00:33

正文

翻译：JULIA 来源： Julia法规翻译

26.07.2017

The MRA between Japan and EU will be extended

日本和欧盟将扩展其MRA

Besides other sections of the Economic PartnershipAgreement between the EU and Japan, the Mutual Recognition Agreement on GoodManufacturing Practice to new pharmaceutical products (MRA) will also beamended. This was communicated in a summary by the EU Commission. However the process is notfinalised yet and some parts of the agreement still need "finetuning" and final agreement. Once the agreement in principle will beconfirmed by the leaders of the EU and Japan, the respective document will beofficially published.

除了经济伙伴协议之外，EU和日本之间的新药GMP互认协议（MRA）也将进行修订。这是EU议会的一个摘要中所说的。当然，具体流程还未最终确定，协议的一些部分还需要“微调”，最终形成正式协议。一旦协议原则上由EU和日本领导确认，则相关的文件将会正式发布。

The extended scope of the MRA will include activepharmaceutical ingredients (APIs), biologics, vaccines and immunologicals. Thisis a "major achievement after numerous attempts and years ofdiscussion". It is expected that this will bring "substantialbenefits" to the pharmaceutical industries in both areas. It is planned tocomplete all the formal procedures soon to allow the entry into force.

MRA扩展后的范围将包括原料药（API）、生物制品、疫苗和免疫产品。这是“经过大量努力和多年讨论之后获得的重大成就”。该协议有望给双方制药企业带来“巨大的利益”。计划所有正式程序将很快完成并生效。