GMP News
21/12/2016
End of TTIP? What about the MRA with FDA?
TTIP将终结？与FDA的MRA要何去何从？
A possible agreement between the European Medicines Agency EMA and the US Food and Drug Administration FDA on mutual recognition of drug facility inspections is part of the Transatlantic Trade and Investment Partnership (TTIP). The idea was to have the agreement signed already in January 2017.
This was noted in a report of the EU Commission: "The state-of-play and the organisation of the evaluation of the US and the EU GMP inspectorates were discussed. In light of the progress achieved, the conclusion of a mutual recognition agreement of Good Manufacturing Practices (GMPs) inspections, by January 2017, is under consideration."
EMA和美国FDA之间可能达成的药厂检查互认协议本是TTIP的一部分，本来是要在2017年签订的。在EU委员会的报告中已经提到了这点“双方讨论了进展情况，以及美国和欧盟GMP检查的评估组织。根据已取得的进展，GMP检查互认协议可以在2017年1月达成。”
But currently, with the election of Donald Trump as the next president of the USA, TTIP will have a rather low chance for implementation. The rejection of free trade agreements was a central message during Trumps' election campaign. The conversations about TTIP have currently entered a kind of rest phase.
但是现在由于特朗普当选为美国下届总统，TTIP实施的可能性变得很小。特朗普竞选演讲中所传达的核心信息是拒绝自由贸易协议，因此目前关于TTIP的对话已进入类似休眠阶段。
Nevertheless the MRA was also discussed at the 84th GMP/GDP Inspectors Working Group with Interested Parties at the European Medicines Agency (EMA) on 23 November 2016. Like every year, the European QP Association was also invited to attend this meeting. At the last meeting, EQPA was represented by Dr Afshin Hosseiny, who is also Co-Chairman of the ECA Executive Board. During the meeting it was pointed that EU is still aiming to sign off the agreement, although there was some concern that the new administration may decide to change it or cancel altogether. If signed, there will be a transition period for the implementation. US FDA still wants to satisfy itself on each member state. "It is not clear how this is going to be achieved, but import testing will be part of the negotiations." Dr Hosseiny says. This could possibly mean that not all member states are approved at the same time, which is not really going to fit with the EU philosophy. It is worth to mention that the agreement will not include import testing; so any imported product from USA has to be retested in EU before release. "It is a goal to include import testing, but it is not clear when that can be implemented".
尽管如此，在EMA于2016年11月23日第84次GMP/GDP检查员工作组中还是与利益相关方讨论了MRA。与往年一样，欧洲QP协会也受到邀请出席了该次会议。在上次会议中EQPA的代表是Dr Afshin Hosseiny，他同时也是ECA董事会的副主席。在会议期间，有人指出EU仍期望签署协议，尽管会担忧新一届政府可能会改变协议或者是全部取消。如果签署，则会有一个实施过渡时期。美国FDA仍想要满足其各州的要求。“现在还不清楚要如何达成，但进口检测将会是谈判的一部分”， Dr Hosseiny说。这样可能意味着美国并不是所有州都会在同一时间得到批准，而这并不真正符合EU的宗旨。值得一提的是协议不会包括进口检测，因此所有从美国进口的药品在放行前都必须在EU重新检测。“在协议中也放入进口检测是目标之一，但还不清楚何时才能实施”。
It is important to mention in this context that there has been an "Agreement on Mutual Recognition between the European Community and the United States of America" signed on 4.2.1999, with a chapter 6 on "Pharmaceutical Good Manufacturing Practices (GMPs)". This MRA included a three-year transition period in which the US FDA wanted to satisfy itself on each Member State's inspection practice. After performing several mutual inspections, the FDA made proposal to have the MRA limited to only some Member States. This was not acceptable for the EU. So the MRA never became effective.
在此情况下还要提到的很重要的一点是在199年4月2日也曾签署过一份《欧共体与美国互认协议》，其中第6章是“药品GMP”。该MRA包括有一个3年的过渡期，在过渡期，美国FDA想要满足其各州的检查规范需求。在实施了几次互认检查之后，FDA建议将MRA限制在少数几个州。而EU不能接受此条件，因此MRA就一直没有生效。
And what does FDA think? In a
presentation given by Janet Woodcock (Director CDER) at the FDA/CMS Summit on 14 December in Washington, she said that "Negotiating, with Global Operations Office, a Mutual Reliance Agreement with Europe on facility GMP inspections" is still on the programme.
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