USA and EU adopt MutualRecognition Agreement - Does it mean the End of FDA Inspections in Europe?

美国和欧盟采纳互认协议----这意味着FDA不会再去欧洲检查吗？

On 2nd March 2017, the US FDA and the EU (EMA)informed that they concluded a so-called MRA (Mutual Recognition Agreement).Such agreements are intended to mutually recognize GMP inspection systems. As aconsequence, the GMP Compliance of a site is reviewed by the respectiveinspection authority. Afterwards, the FDA can use EU inspection results andvice-versa. FDA inspections in the EU or EU inspections in the USA should beonly performed in exceptional cases.

2017年3月2日，美国FDA和EU（EMA）发布通知称他们达成了所谓的MRA（互认协议）。此类协议的目的是互相认可对方的GMP检查体系。有此协议后，一个场所的GMP符合性只由相对应的检查机构进行审核就可以了。之后，FDA可以使用EU检查结果，反之亦然。FDA在EU的检查和EU在美国的检查只会是在例外的情形下进行。

The EU has already concluded MRAs withother countries like Australia, Canada, Japan, Switzerland and NewZealand. The MRA with the USA has already been under discussion since thenineties. In 1998, a contract was made but never put into practice, though,because of the two very different legal systems. The question of communicatingdetailed inspection results has been a recurring subject of discussions.Moreover, the FDA had doubts about the consistent quality of inspections inEurope. Equivalent systems had been recognised for some countries but it hadalso been noticed that some EU countries couldn't show an inspection systemcomparable to that of the FDA. Yet, the EU has consistently made clear that theagreement could only be concluded with the EU and not with individual EU memberstates.

EU已经与其它一些国家达成互认协议，如澳大利亚、加拿大、日本、瑞士和新西兰。与美国的MRA从上世纪就开始讨论了。1998年，签署了一份合同，但从来都没有实践过，因为很显然他们的立法体系是完全不同的。详细的检查结果的沟通问题反复出现在讨论中。更有甚者，FDA曾经质疑欧洲的检查质量的恒定性。有些欧洲国家的系统已被认可具有等同性，但有些EU国家的检查体系仍无法与FDA相提并论。EU已经表达的非常清楚，如果要达成协议，必须是与EU达成而不能是与单个欧盟成员国。

In the context of negotiations over the last years,progress has been made with regard to those points. Since 2014, cooperation hasbeen intensified. Thereby, a Joint Audit Programme has been established. Sofar, the FDA has participated as an observer in 13 audits performed among EUcountries. During the first audit of this kind, inspectors from England andNorway audited the Swedish GMP inspectorate under FDA supervision.

在过去多年谈判中，这方面不断取得成就。自2014年以来，双方加强了合作，因此，有了联合审计程序。截止目前，FDA已经参加了13次对EU国家的审计。在第一次此类审计中，来自英格兰和挪威的检查人员在FDA监管下审计了瑞士的GMP检查组织。

It will be interesting to see how the procedural rulesare concretely applied in case of suspension of recognition of an authority -e.g. when the FDA refuses to recognise the inspection authority of an EUcountry and vice-versa. Article 13 specifies that. According to it, "EachParty has the right to suspend recognition of a recognized authority of theother Party. This right shall be exercised in an objective and reasoned mannerand communicated in writing to the other Party and the recognized authority."[...] Furthermore: "Upon the suspension of an authority previously listedas a recognized authority, a Party is no longer obligated to accept officialGMPs documents of the suspended authority."

如果看到对某个国家药监机构的认可被拒绝，不知道要如何实施具体的程序，这应该是很有意思的。例如，如果FDA拒绝认可某个EU国家的检查机构，或者反过来。第13条中说，据此“任何一方有权拒绝认同另一方已被认可的机构。此权利的执行应客观合理，主张方应以书面方式通知另一方和涉事机构”。【……】另外“一方拒绝认可某个原来列入被认可机构清单的机构之后，拒绝方不再有义务接受被拒绝方正式的GMP文件。”

The agreement which has been made shall cover bothmedicinal products and APIs. Human blood, human plasma, human tissues andorgans, and veterinary immunologicals are excluded from the scope of theagreement. The new agreement should come into force on 1st November 2017.Until then, the FDA wants to review the authorities of further EU countries.Similarly, the EU wants to check the regulatory authorities in the different USFederal States.

协议内容覆盖了药品和原料药。人血、人类血浆、人类组织和器官和兽药免疫产品不在协议范围内。新协议将于2017年11月1日生效。彼时，FDA将审核更多的EU国家。同样，EU也将检查美国各州的法规机构。

Please alsoe read the EU/EMA's press release aswell as the FDA's news release.

更多信息，也请参见EU/EMA信息发布以及FDA新闻发布。