The European Medicines Agency (EMA) spent most of 2017 trying to navigate how to deal with the UK’s move out of the EU, the agency’s own move to Amsterdam (with an eye toward being operational by 30 March 2019), and the subsequent loss of UK expertise, among other work described in a report on 2017 released Wednesday.
Christa Wirthumer-Hoche, chair of EMA’s management board, explained some of the shifts that have occurred since the Brexit announcement, writing in the report’s forward that national institution investments in capacity and capabilities, as well as the two EMA working groups on operational preparedness, will help to ensure “the network will be able to compensate for the UK’s work and expertise and continue to protect the health of patients and animals in the EU.”
The strain of Brexit on EMA, with preparations for relocation and the operational changes, also meant some of the agency’s ongoing activities had to be put on hold.
EMA Executive Director Guido Rasi wrote: “We have had to re-prioritise some work, and cut down or delay some activities. For example, reducing the number of trainings and audits, meetings and conferences with key stakeholders and partners, and delaying some much-needed upgrades to our own IT infrastructure. Clearly, this is not something that we can sustain in the long term because it would eventually impact the quality and efficiency of our activities.”
But EMA is also quick to stress that 2017 was not just about Brexit. The year also saw the board finalize its three-year data-gathering initiative, needed by the European Commission to support a redraft of the legislation governing the fees charged by EMA, and launch a new and improved version of its EudraVigilance system to strengthen the safety monitoring of medicines and make the reporting process more efficient.
And last September, EMA held its first-ever public meeting to increase engagement with the public.
Last June, the European Commission confirmed that the US Food and Drug Administration has the capability, capacity and procedures in place to carry out GMP inspections at a level equivalent to the EU.
FDA then confirmed the capabilities
of eight EU member states (Austria, Croatia, France, Italy, Malta, Spain, Sweden and UK), and EMA said the remaining EU inspectorates will continue to be assessed until 15 July 2019.
In 2017, EMA agreed with Japanese regulators to establish a fellowship program based on its fellowship model with FDA. And EMA also hosted a meeting with Japan’s PMDA and FDA to discuss regulatory approaches for the evaluation of antibacterial agents.
And based on the success of its two-day awareness session last autumn, with 60 regulators from non-EU, African, Asian and American countries and several international non-governmental organizations, EMA said it will organize further sessions.
EMA adopted a total of 81 eligibility recommendations in 2017 in its PRIority MEdicines (PRIME) scheme, 20% more than in 2016, to provide early and enhanced support to medicines that can potentially address patients’ unmet medical needs.
EMA and HTA bodies work together to provide medicine developers with simultaneous feedback on development plans with the aim of ensuring that the data requirements for both parties are met.
Requests for joint scientific and protocol assistance with HTAs and EMA also rose by 26% in 2017, and with the launch of a new platform for parallel consultation in July 2017, EMA noted that of the 29 requests for parallel advice on evidence generation in 2017, seven were submitted via this new tool.
But unlike in the US, the number of applications for orphan designations in 2017 actually fell from 2016 highs. The agency said it received 260 applications for orphan designation in 2017 (vs. 329 in 2016), and granted a designation to 144 applications (vs. 220 in 2016).