Introduction
by Emer Cooke
EMA Executive Director
As the Executive Director of EMA, I look back on 2022 with a sense of pride and satisfaction in how we tackled new phases of the pandemic, negotiated a new health crisis and expanded on our mission.
Although we saw some return to more routine activities, largely thanks to the speed of scientific progress and the roll-out of effective vaccination campaigns across the EU, the COVID-19 virus continued to force us to pivot, innovate and adapt.
In 2022, new variants of concern emerged requiring appropriate counter measures by Member States to protect the health of citizens. We invested additional efforts into being an authoritative, reliable source of information for EU citizens and our experts continued to work around the clock to ensure the review of the safety and effectiveness of much-needed vaccines and therapeutics.
As a result, we have many more options to prevent serious hospitalisation and death now than we did in 2021. By the end of the year, we had a total of seven COVID-19 vaccines authorised for use in the EU. Two of these, the mRNA vaccines, were further developed and tailored to specific strains of the SARS-CoV-2 virus. This gave Member States the flexibility they needed to adapt when it came to launching their own vaccination campaigns.
In March, we started to operate under our extended mandate, which was shaped by the extensive role we had played through this health crisis. This mandate gives us added responsibilities in the area of crisis co-ordination and response. As well as formalising some of our ad hoc procedures, it gives us new tools to respond effectively to future public health crises and tackle medicine shortages.
The first real test of our extended mandate came in mid-2022 through the mpox (monkeypox) public health emergency. This crisis put our new responsibilities to the test. EMA played a central role in co-ordinating actions and providing scientific recommendations on critical medicines and vaccines as well as putting measures in place to avoid shortages.
Our extended mandate also set the framework for the establishment of DARWIN EU – a federated model for collecting real-world evidence from across the EU on diseases, populations and the uses and performance of medicines and vaccines right through their lifecycle. Potentially, this is a sea change for medicines regulation, feeding into a future European health data space.
Despite the ongoing focus on crises, our regulatory approvals continued with 89 human medicines recommended for approval by the Committee for human medicines. This included the first authorised product worldwide for the prevention of respiratory syncytial virus (RSV) disease in newborns and infants, as well as six advanced therapy medicines, notably the first gene therapy for severe and moderately severe haemophilia B. Under the EU Medicines for all (EU-M4All) procedure, EMA evaluated a new vaccine against dengue and two diabetes treatments that address important public health issues outside the EU. In the veterinary area, we recommended 10 new medicines for approval, including the first DNA vaccine for dogs.
Just as important has been the progress made in the implementation of two new major pieces of legislation, bringing profound changes to the way clinical trials are regulated and veterinary medicines are supervised in the EU.
In January, the Clinical Trials Regulation and the Clinical Trials Information System, or CTIS, came into force setting the building blocks to reinvigorate and facilitate clinical research in the EU. This is a major change, a move from entirely national approaches to a system with a single EU submission, coordinated assessment between the Member States and high levels of transparency never seen before for clinical trials.
The Veterinary Medicines Products Regulation, which came into force in January, also helps to foster product innovation as well as facilitating wider access to information about medicines for animals, better monitoring of suspected side effects, and new measures to limit the development of antimicrobial resistance. As part of the intense implementation efforts, EMA successfully launched the Veterinary Medicines information website at the beginning of the year.
The last three years have brought untold change and put new pressure on our healthcare systems. One of the key things we have learned during this crisis is how to quickly adapt to a dynamic new world.
As we look ahead, EMA will continue to develop, adapt and streamline our regulatory processes while maintaining the highest standards for quality, safety and efficacy of medicines. We will further strengthen scientific collaboration between regulators, governments, industry and patients and step up our communication to EU citizens. And along with all of the incredible EMA staff and experts from the national authorities in our committees and working parties, I look forward to continuing the important work we do with our partners and stakeholders to further promote public and animal health in the EU.