翻译：JULIA 来源：Julia法规翻译
30 April 2019
EMA/238100/2019
Committeesand Inspections
Questions & answers on the impact of Mutual Recognition Agreement between the European Union and the United States as of 30 April 2019
2019**年4月30日起欧美间互认协议影响问答**
Q1:What is in place since 1 November 2017?
A1:The provisions of the agreement relating to the mutual recognition of inspections took effect on 1 November 2017. This milestone followed the confirmation, in June 2017, by the European Commission (EU) that the US Food and Drug Administration (FDA) has the capability, capacity and procedures in place to carry out good manufacturing practice (GMP) inspections at a level equivalent to the EU and on 1 November, the confirmation by the FDA of the capability of eight Member States –Austria, Croatia, France, Italy, Malta,Spain, Sweden and United Kingdom.
FDA confirmed the capability of the following further Member States on:
– 1 March 2018: Czech Republic, Greece, Hungary and Romania
– 1 June 2018: Ireland and Lithuania
– 14 September 2018: Portugal
– 16 November 2018: Belgium, Denmark, Finland and Latvia
– 28 November 2018: Estonia;
– 7 February 2019: Poland and Slovenia;
– 29 April 2019: Bulgaria and Cyprus
问：自11月1日起有哪些已完成？
答：互认协议中与检查互认有关的条款自2017年11月1日开始实施。此里程碑是在2017年6月由EU确认美国FDA有能力、有人力和程序以等同于EU的水平执行GMP检查之后确定的。2017年11月1日，FDA已确认了8个成员国的检查能力（奥地利、克罗地亚、法国、意大利、马尔他、西班牙、瑞典和英国）。
FDA确认了更多成员国：
– 20180301：捷克、希腊、匈牙利和罗马尼亚
– 20180601：爱尔兰和立陶宛
– 20180914：葡萄牙
– 20181116：比利时、丹麦、荷兰和拉脱维亚
– 20181128：爱沙尼亚
– 20190207：波兰和斯洛文尼亚
– 20190429：保加利亚和塞浦路斯
Q2:Does this Mutual Recognition Agreement mean that from 1 November 2017 EU and US regulators will stop conducting GMP inspections in each other’s territories?
A2: As of 1 November 2017, the EU Member States will not duplicate inspections conducted by the FDA. At the same time, it is expected that the FDA will not duplicate inspections conducted by a recognised authority*
Exceptionally, both the EU and FDA reserve the right to inspect in each other’s territory at any time.
问：此互认协议是否意味着自2017年11月1日起，EU和美国的药监人员会停止对另一方领土实施GMP检查？
答：自2017年11月1日起，EU成员国将不会重复FDA已执行过的检查。同时，预期FDA也不会重复经认可的药监当局已执行过的检查。
在例外情况下，EU和FDA都保留权力在任何时间对另一方领土执行检查。
Q3:Does this Mutual Recognition Agreement mean that from 1 November 2017, EU andUS regulators can rely on each other’s GMP inspections, not only in their territories but also outside the EU and the US?
A3:Initially, the EU and the FDA will focus on inspections conducted within their respective territories. However, the EU and the FDA have the option to rely oninspection reports issued by a recognized authority for manufacturing facilities located outside their respective territories. See Article 3 (1) ofthe GMP Sectoral Annex to the MRA. Please note that this provision in the MRA to accept the outcome of inspections conducted outside the US or the EU, is not yet operational and further guidance will be published in due course.
问：此互认协议意味着自2017年11月1日起，EU和美国药监人员可以依赖于对方的GMP检查，除了本土的检查，是否还包括EU和美国以外的地区？
答：刚开始，EU和FDA将关注于在其对应的领土内所实行的检查。但是，EU和FDA也可以依赖于经过认可的药监当局对位于其对应领土以外的生产场所签发的检查报告。参见MRA的GMP部分附录第3（1）条。请注意MRA中接受在美国或EU以外执行的检查结果的条款尚未开始执行，在适当时候会发布进一步指南。
Q4:What is the difference between this agreement and the Mutual Recognition Agreement signed in 1998?
A4:The EU and the US signed the agreement on mutual recognition between the European Community and the United States of America in 1998. The agreement included a Pharmaceutical Annex providing reliance on each other’s GMP inspections. However, this was never fully implemented. The 2017 amendment tothe Sectoral Annex is building on the 1998 MRA. It benefits from the cooperation of the EU and the US in the past years through various pilot initiatives on GMP inspections.
问：此协议与1998年互认协议有何区别？
答：EU和美国于1998年由欧洲共同体与美国签署了互认协议。协议包括一份药业附录，为双方GMP检查提供了可信性。但是，该协议从来都没有全面实施过。2017年对部门附录的修正是基于1998年MRA的。它利益于EU和美国在过去数年中在GMP检查方面各种合作尝试。
Q5:What products are included in the scope of the Mutual Recognition Agreement?
A5:The indicative scope of the amended Sectoral Annex covers a broad range of human medicines, as well as biological and veterinary medicines with specific exclusions for human blood, plasma, tissues and organs as well as forveterinary immunologicals. The current operational scope of the agreement includes only human medicinal products, with the exclusion of vaccines and plasma derived products.
问：哪些产品是包括在互认协议范围内的？
答：修订后的部分附录覆盖了人药中很宽的范围，还包括有生物药品和兽药，但人血、血浆组织和组织以及兽药免疫药品除外。协议目前的执行范围仅包括人药，疫苗和血浆制品除外。
Q6:What products are currently excluded from the scope of the Mutual Recognition Agreement?
A6: Veterinary products are not immediately included in the operational scope of the agreement, but they will be considered for inclusion by no later than 15 July 2019. To this end discussions between technical experts have been initiated. Human vaccines and plasma derived products are not immediately included within the operational scope of the agreement, but their inclusion will be considered by no later than 15 July 2022.
Human blood, plasma, tissues and organs as well as veterinary immunologicals are excluded from the scope.
问：目前哪些产品是排除在互认协议范围以外的？
答：兽药产品不会立即包括在协议的运作范围内，但最迟将于2019年7月15日会考虑将其包括在其中。人用疫苗和血浆衍生物不会立即包括在协议的运作范围内，但最迟将于2022年7月15日会考虑将其包括在其中。
人血、血浆、组织和器官以及兽药免疫药品不在范围内。
Q7:Are combination products included in the scope provided they are regulated by FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) in the US and registered as a “medicinal product” in the EU?
A7: The applicable product scope is defined by the provisions of Article 4 and Appendix 3 of the Sectoral Annex. Products falling within this scope arecovered by the MRA.
问：组合产品如果在美国是受到FDA的CDER和CBER的管制，并在欧盟注册为“医疗产品”，是否包括在范围内？
答：适用产品范围是由第4条和部门附录3内的条款定义的。属于此范围的产品则包括在MRA里。
Q8:What will happen next?
A8:The number of recognized authorities will be gradually expanded with further assessment. The next milestones are 1 June 2018 for FDA to confirm capability of a further two Member States and 1 December 2018 for six more Member States.The MRA foresees that all EU Member States are assessed by latest 15 July 2019.
问：接下来会发生什么事情？
答：会有进一步评估，被认可的药监当局数量将会逐步增加。MRA预计到2019年7月15日，所有的EU成员国都将完成评估。
Q9:Where can I find an up-to-date list of recognized authorities?
A9:The EU is publishing the list of recognized authorities . This list will be regularly updated once a Member State has been found capable by the FDA.
问：我要怎么找到更新后的被认可的当局清单？
答：EU会发布被认可的药监当局清单。此清单将在FDA认可一个成员国有能力之后定期更新。
Q10:Can I stop import testing now?
A10:No, this provision will only enter into force once all EU Member States have been assessed and recognised by the FDA, i.e. by July 2019.
问：我现在能停止进口检测吗？
答：不能，此条款只有当所有EU成员国均经过FDA评估，即至2019年7月才开始执行。
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