Foreword
by Christa Wirthumer-Hoche
Chair of EMA Management Board
(March 2016 – March 2022)
I am delighted to introduce EMA’s annual report for 2021 which highlights the Agency’s important contributions to public health during the second year of the COVID-19 pandemic.
As chair of the EMA Management Board, I am particularly proud of the unparalleled coordination between EMA, the Member States and the European Commission that formed the basis for the joined-up response to the ongoing public health crisis. At the same time, the European medicines regulatory network's business continuity plan ensured that we, as a network, were also able to deal efficiently with the core regulatory activities needed to protect public and animal health.
EMA and the national experts worked tirelessly to fast-track the evaluation of COVID-19 vaccines and therapeutics that the European Union (EU) needed so urgently to fight the pandemic. This meant an unprecedented workload for EMA and the national competent authorities. The Management Board called for an increase in resources to ensure that rapporteur teams continued to be available to conduct assessments within the shortest possible timeframes.
COVID-19 was not the only topic that kept us occupied in 2021. The Agency, together with Member States and the European Commission, prepared for the implementation of two important pieces of new legislation that entered into force at the beginning of 2022: the Clinical Trials Regulation (CTR) and the Veterinary Medicinal Products Regulation.
The Clinical Trials Information System (CTIS), enabling the centralised application and management of clinical trial data in the EU, was developed by EMA with the support of the European medicines regulatory network and became a regular item on the agenda of the Management Board. During an extraordinary meeting in April, we discussed the outcomes of the independent audit of the new system and were able to set the go-live date of the system for 31 January 2022. CTIS will become the single entry point for sponsors and regulators for the submission and assessment of clinical trial applications. Its searchable database for healthcare professionals, patients and the general public will significantly increase transparency on clinical trials in Europe.
The new Regulation for Veterinary Medicinal Products, which became applicable on 28 January 2022, required the creation of a series of databases at EU level, and EMA led on their development and implementation. The Veterinary Regulation will stimulate innovation and increase the availability of and access to safe and high-quality veterinary medicines while also strengthening the EU’s fight against antimicrobial resistance.
I also would like to highlight the progress made in harnessing the power of data analytics to support medicine regulation. First, the Big Data Steering Group delivered a strategy setting out principles to guide the definition, adoption and implementation of data standards for the European medicines regulatory network. Second, the Data Analysis and Real World Interrogation Network (DARWIN EU) took shape as a coordination centre that will provide evidence on the use, safety and effectiveness of medicines for human use, including vaccines, from real-world healthcare databases across the EU.
Finally, I would like to express my gratitude on behalf of the Board to colleagues across the network, to the European experts, the Commission and to EMA staff for all their hard work during the year. For me, it has been a great honour to lead the Board over the last six years, which have been the most challenging times the network ever encountered. The pandemic has not yet ended and we will have to continue to work closely together to further improve our response to this crisis and to ensure that we have efficient tools available to deal with any future public health emergencies.