The Brexit1transition period is due to conclude on December 31, 2020 when the United Kingdom (UK) will become a third country to the European Union (EU). Drug manufacturers and contract test laboratories should be proactive in understanding the potential regulatory considerations relating to commercial drug product release testing and Brexit.
This article provides a brief overview of the EU-U.S. Mutual Recognition Agreement (MRA) and discusses considerations for implementing viable alternatives for testing to support EU, U.K. and U.S. drug product releases when Brexit moves ahead.
Recognizing areas to reduce the burden of regulatory inspection
在过去，药物制造设施 - 即使是遵守历史悠久的人 - 通常被欧盟当局和美国食品和药物管理局检查，有时在同一年内检查。Recognizing that these replicated efforts use resources that could be reallocated toward drug manufacturing facilities with higher public health risks, the EU and FDA agreed to rely on each other’s inspection reports (following a program of joint inspections) and encourage greater international harmonization of compliance standards while still protecting consumer safety.
该决定在过去两年中正式化在相互认可协议（MRA）中，该协议被定义为两个或多个国家之间的协议，以承认其他国家的具体进程或程序（see the FDA FAQs）。MRA包括用于人类使用，中间体和活性药物成分的营销成品药品和生物产品，但目前排除了一些产品，如疫苗和先进治疗药品（ATMPS）。
The MRA between the EU and US allows the FDA and EU inspectorates to use inspection reports and other related information obtained during drug manufacturing facility inspections to determine if a facility is manufacturing high quality drugs. These inspections can be conducted by an EU inspectorate or by the FDA; both entities still reserve the right to inspect each other at any time and in any country.
The benefits of a Mutual Recognition Agreement in terms of Brexit
Currently, with the EU-US MRA in place, EU authorities can rely on FDA inspections of U.S. facilities – and vice versa – and waive retesting of US products upon importation into the EU, provided that Qualified Persons verify controls have been carried out in the US The UK follows EU Good Manufacturing Practice (GMP) regulations, and, in the current pre-Brexit state, also operates under the U.S.-EU MRA.
营销授权持有人将能够继续依靠英国进行的QC测试，其中Covance在Harrogate，York和Huntingdon中有网站。We believe that during this potential transition period it is likely that a similar MRA will be formed between the EU and U.K. Both parties have followed the same GMP regulations over the last 40+ years and have strong ethical motivations to continue the freedom of movement of medicines.
In the unlikely scenario of a delayed agreement between the U.K. and EU post-Brexit, Covance has set up a mitigation strategy where the U.S.-based Covance site in Greenfield, Indiana can take on product release testing for the EU market operating under the current EU-U.S. MRA. The Greenfield site has a strong history of successful GMP regulatory inspections with no 483s or major/critical findings reported since 2011. This includes the MHRA (U.K.) in March 2017; FDA (U.S.) – Jan 2016; FDA (U.S.) – Nov 2013; and Health Canada – May 2012.
在面对未知的同时定位平滑过渡
具有全球产品发布的赞助商需要一个合作伙伴，可以提供对全球许多设施的访问，并提供有关如何最佳符合全球法规的指导。我们的CMC队在Covance领域相信，我们的全球发布策略将有助于降低任何与Brexit周围的不确定性相关的药物与药物相关延误的风险。为未知做准备，并确保您的程序和流程最适合平滑过渡。
1Brexit is shorthand for “British exit” – the United Kingdom’s vote in a June 23, 2016, referendum to leave the European Union.
