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Julia的法规翻译
Questions & answers on theimpact of Mutual Recognition Agreement between the European Union and theUnited States as of 1 March 2018 2018年3月1日起欧美间互认协议影响问答 Q1: What is in place since 1November 2017? A1: The provisions of theagreement relating to the mutual recognition of inspections took effect on 1November 2017. This milestone followed the confirmation, in June 2017, by theEuropean Commission (EU) that the US Food and Drug Administration (FDA) has thecapability, capacity and procedures in place to carry out good manufacturingpractice (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 on 1 March 2018the capability of a further four Member States –Czech Republic, Greece,Hungary and Romania. 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（意大利、西班牙、法国、希腊、克罗地亚、英国、瑞典和奥地利）。2018年3月日，FDA确认了另4个成员国—捷克、希腊、匈牙利和罗马尼亚。 Q2: Does this MutualRecognition Agreement mean that from 1 November 2017 EU and US regulators willstop conducting GMP inspections in each other’s territories? A2: As of 1 November 2017, theEU Member States will not duplicate inspections conducted by the FDA. At thesame time, it is expected that the FDA will not duplicate inspections conductedby a recognised authority* Exceptionally, both the EU and FDA reserve theright 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 MutualRecognition Agreement mean that from 1 November 2017, EU and US regulators canrely on each other’s GMP inspections, not only in their territories but alsooutside the EU and the US? A3: Initially, the EU and theFDA will focus on inspections conducted within their respective territories.However, the EU and the FDA have the option to rely on inspection reportsissued by a recognized authority for manufacturing facilities located outsidetheir respective territories. See Article 3 (1) of the GMP Sectoral Annex tothe MRA. 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。 Q4: What is the differencebetween this agreement and the Mutual Recognition Agreement signed in 1998? A4: The EU and the US signedthe agreement on mutual recognition between the European Community and theUnited States of America in 1998. The agreement included a Pharmaceutical Annexproviding reliance on each other’s GMP inspections. However, this was neverfully implemented. The 2017 amendment to the Sectoral Annex is building on the1998 MRA. It benefits from the cooperation of the EU and the US in the pastyears 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 includedin the scope of the Mutual Recognition Agreement? A5: The scope of the amendedSectoral Annex covers a broad range of human medicines, as well as biologicaland veterinary medicines with specific exclusions for human blood, plasma,tissues and organs as well as for veterinary immunologicals. 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。 Q6: What products are currentlyexcluded from the scope of the Mutual Recognition Agreement? A6: Veterinary products arenot immediately included in the operational scope of the agreement, but theywill be considered for inclusion by no later than 15 July 2019. To this enddiscussions between technical experts have been initiated. Human vaccines andplasma derived products are not immediately included within the operationalscope of the agreement, but their inclusion will be considered by no later than15 July 2022. Human blood, plasma, tissues and organs as well asveterinary 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。 Q7: Are combination productsincluded in the scope provided they are regulated by FDA’s Center for DrugEvaluation 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 productscope is defined by the provisions of Article 4 and Appendix 3 of the SectoralAnnex. Products falling within this scope are covered 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 begradually expanded with further assessment. The next milestones are 1 June 2018for FDA to confirm capability of a further two Member States and 1 December2018 for six more Member States. The MRA foresees that all EU Member States areassessed 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 recognizedauthorities? A9: The EU is publishing thelist of recognized authorities[1].This list will be regularly updated once a Member State has been found capable bythe 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 testingnow? A10: No, this provision willonly enter into force once all EU Member States have been assessed andrecognised 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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发表于 2018-3-3 12:30:34
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oes this Mutual Recognition Agreement mean that from 1 November 2017 EU and US regulators will stop conducting GMP inspections in each other’s territories?