Introduction

Preparing the pharmaceutical sector for the UK’s withdrawal from the EU continued to consume significant resources from EMA and the European medicines regulatory network. Assuring the continuity of the supply of medicines to patients in the EU became the focus of our work. Together with the European Commission and the Member States, we gave guidance and actively encouraged companies marketing human and veterinary medicines in the EU to prepare their development and manufacturing arrangements for Brexit. Our proactive approach paid off: the risk of shortages for centrally approved medicines in case of a no-deal Brexit was very low at the end of 2019. The preparations will continue in 2020 until the end of the transition period.

However, these achievements came at a cost for the Agency. Most of the activities we had to postpone and suspend in 2018 in anticipation of the physical move remained on hold in 2019. These included guideline development, engagement in international activities, the majority of working party meetings and the Agency’s landmark policy on the proactive publication of clinical data. We were also faced with new activities that absorbed significant resources, including implementation of major pieces of legislation – for veterinary medicines, medical devices and data protection. In addition, the detection of nitrosamine impurities in some medicines presented a new challenge that required prompt, transparent and coordinated action by EMA and the national competent authorities.

Thus, we were only able to reinstate a few activities in the second half of 2019. These mainly concerned projects to improve efficiency, such as enhancing those IT systems supporting the medicines evaluation process and the digitalisation of administrative processes.

Despite all the challenges of 2019, I am proud that EMA remained firmly focused on its public health mission. Altogether, EMA recommended the authorisation of 66 new medicines for human use, some of them presenting scientific advances that can make a real difference to people’s lives, such as a new gene therapy for the treatment of beta-thalassaemia and the first Ebola vaccine. EMA continued to closely monitor the safety of medicines on the market and take action when needed. A good example of this is that, in 2019, the product information for 405 centrally authorised medicines was updated on the basis of new safety data.

EMA also recommended 15 new veterinary medicines for marketing authorisation, including five new active substances and four vaccines. The fight against antimicrobial resistance (AMR) remained a priority in this area. 

We made progress across the EU in handling shortages of medicines. A new information-sharing system for EU regulators, piloted in 2019, supports the prevention and management of shortages and shows yet again how much we can gain in the EU through cooperation and mutual reliance.

Another important network initiative concerned developing key principles for the development and use of electronic product information (ePI) for human medicines in the EU. By seizing the opportunities of digitalisation, we can increase citizens’ access to information on medicines.

Given the importance we place on early dialogue with medicines developers to generate high-quality data for scientific assessment, I was pleased that the European Ombudsman publicly recognised the value and need for scientific advice in her conclusions of an enquiry into our pre-submission activities. The progress EMA made in better explaining the rationale and process behind its work in the early phases of medicines development has certainly helped to shift the debate.

With all the challenges we are facing, getting fit for the future became a top priority in 2019. We progressed our strategy for advancing regulatory science to 2025 in dynamic discussions with our stakeholders through a public consultation and two workshops. This will allow us to finalise a strategy that can deliver high value in both the human and veterinary sectors and improve the way we regulate medicines in the EU. One of the areas where innovative approaches are needed is big data: here, the recommendations made by the Big Data Task Force pave the way towards creating a broader evidence base for regulatory decisionmaking coming from big data.

Being ready for the future whilst making best use of available resources also led us to rethink EMA’s internal organisation. The more agile organisation we hope to achieve through the “future-proofing” exercise that started in 2019 should help EMA strengthen its ability, together with our partners in the network, to innovate and perform new activities.

I approach 2020 with the hope that we can now finally close the chapter of our relocation and focus on the future. This will be my last year at the helm of EMA, an organisation that has been my privilege to lead, and it is my ambition to leave it fully prepared to embrace the scientific and technological advances ahead for better human and animal health.

Before I present this year’s annual report, I would like to thank all those who have been part of our journey and who contribute to EMA’s work: the members of its scientific committees, the working parties and scientific advisory groups, the Management Board and the national experts, our stakeholders and, of course, EMA’s staff. 

March 2020