Foreword
by Christa Wirthumer-Hoche
Chair of EMA Management Board
It is my pleasure to introduce EMA’s annual report for 2019. I would like to congratulate EMA on its relocation from London to Amsterdam. This was a huge administrative, logistical and managerial challenge, made even more complicated by the need to move twice within the space of one year. It was only thanks to its impressive business continuity planning that the Agency was able to continue all core activities related to the evaluation, maintenance and supervision of medicines which continued throughout this period.
At the end of 2019, the Agency was in as good a shape as it could have been following its move. However, the Board remains concerned about the longer-term prospects for the Agency’s full recovery if the ongoing resource constraints cannot be addressed. The challenges of the move and the associated staff losses had made it necessary to put some activities on hold as 2019 began. EMA was only able to reinstate some of these activities. Important areas of the Agency’s work, such as working parties and guideline development, remained largely suspended throughout the year, creating a significant impact on the European medicines regulatory network overall.
On top of this, the discovery of nitrosamine impurities in some medicines put further strain on the Agency. The Board praises EMA for its public-health-driven handling of the issue and for its part in developing and coordinating a strong EU-wide response to the possible presence of these carcinogenic substances in medicines. Managing this issue will continue to be an increasingly resource-demanding topic in the years to come.
Another area that absorbed a significant number of EMA resources was the implementation of new pieces of legislation. In particular, the New Veterinary Regulation has put a lot of time pressure not only on EMA staff but also on experts and the network as whole. Although this has been managed very well by EMA, which provided scientific and technical recommendations to the Commission to support them with implementation of the Regulation, it remains an area of concern that the Board will continue to monitor.
Despite the challenges, 2019 was also a year in which progress was made in important areas.
To prepare for the UK’s withdrawal from the European Union (EU), the EU27 Member States and EMA redistributed the UK’s portfolio of over 370 centrally authorised medicines to other EU Member States, plus Iceland and Norway. By 1 July 2019, I was glad to see that the new rapporteurs and co-rapporteurs were fully responsible for these medicines.
EMA and the network neared completion of the Regulatory Science Strategy to 2025, the plan for advancing engagement with regulatory science over the next few years. The Agency organised two further workshops with stakeholders which offered an excellent platform to move discussions forward. Once adopted by the Board in 2020, this strategy will form the backbone of the work of the Agency and network in the coming years.
The Regulatory Science Strategy will then feed into the development of the next joint EU network strategy, which will guide the work carried out by EMA and the national agencies. This covers important topics for the network, medicines, supply chain challenges, data analytics and artificial intelligence. It is important that we have one overarching strategy with the Heads of Medicines Agencies (HMA) over the whole EU network to help address these complex topics.
The EU network training centre continued to play a key role in making sure that the right expertise is available across the network. We now have more experts from national agencies than ever who are registered with the learning management system and moving forward. It will be important to continue the development of curricula on real-world data sources and to develop modules in big data and for telematics projects.
During 2019, there was much discussion in the Board concerning the Clinical Trials Information System, which is necessary for the new Clinical Trials Regulation to come into force. This is one of the most complex and ambitious IT developments ever undertaken by EMA, which needs to integrate systems and processes in place in all Member States into one virtual workspace that works for all. We have set up a governance structure to closely monitor progress. The system has yet to be finalised but we are on the right track now and I look forward to the start of the audit in December 2020.
On a personal note, it was a great honour to be re-elected as chair of the Board in March. I thank you for your trust and look forward to leading the Board for a further three years.
And, finally, on behalf of the Board, my heartfelt thanks goes to colleagues across the network, to the Commission and to EMA staff for all the work achieved during what was a challenging year.
March 2020