EMA Publishes 2022 Annual Report on Human and Veterinary Medicines Evaluation and Monitoring Activities in the European Union

The European Medicines Agency (EMA) has published its 2022 annual reportdocument that provides an overview of the Agency’s activities to protect and promote public and animal health in the European Union (EU).

The report outlines the highlights regarding the evaluation and monitoring of human and veterinary medicines: the EMA recommended ten veterinary and 89 human medicines for marketing authorisation. In addition, on January 28, 2022, the Regulation of Veterinary Medicinesbringing important changes in the regulation of medicines for animals.

Emer Cooke, executive director of the EMA, points out that this regulation “helps encourage product innovationin addition to facilitating wider access to information on animal medicines, better monitoring of suspected side effects and new measures to limit the development of antimicrobial resistance.”

EMA performance

Ongoing and emerging public health emergencies continued to be a key focus area of ​​the EMA and its partners within the European medicines regulatory network in 2022. According to the scientific evaluations of the Agency, new vaccines and treatment options were added to the EU’s arsenal in the fight against COVID-19.

Cooke points out the Agency’s performance “with pride and satisfaction” for how the new phases of the pandemic have been addressed. “Despite the continued focus on crises, our regulatory approvals continued with 89 human drugs recommended for approval by the Committee for Human Medicines”, highlights Cooke, who also points out that this fact included the first product authorized worldwide for the prevention of heart disease. respiratory syncytial virus (RSV) in newborns and infants, as well as six advanced therapy drugs, including the first gene therapy for moderate and severe hemophilia B.

When an outbreak of monkeypox posed an additional public health challenge, the tools to deal with crises established in the context of the Agency’s extended mandate, ensuring a coordinated EU response.

The report, which includes an overview of the EMA’s recommendations on vaccines and treatments for COVID-19 and for the monkey poxalso shows how the EMA continued to address animal and public health needs beyond the ongoing public health emergencies.

EMA achievements

The EMA annual report also draws attention to the Agency’s other important achievements, high-impact activities and challenges in 2022. These include the implementation of the Regulation of Clinical Trialswhich came into force in January 2022, as well as the releases of Clinical Trials Information System (CTIS) and the initiative Accelerating Clinical Trials in the EU (ACT EU).

“Under the EU Medicines for All (EU-M4All) procedure, the EMA evaluated a new dengue vaccine and two treatments for diabetes that address important public health problems outside the EU”, emphasizes Cooke, adding that just as important has been the progress made in the implementation of the new laws mentioned above that have led to “profound changes in the way in which the clinical trials and veterinary medicines are supervised in the EU”.

“The EMA evaluated a new vaccine against dengue and two treatments for diabetes in 2022”

Emer Cooke.

The last three years, as analyzed by the executive director of the EMA, have brought “incalculable changes” and have put “new pressure” on health care systems. “One of the keys that we have learned during this crisis is how adapt quickly to a new and dynamic world,” says Cooke.

Looking ahead, in Cooke’s words, the EMA will continue to develop, adapt and simplify regulatory processes while “maintaining the highest standards of quality, safety and efficacy of medicines”.

“We will further strengthen scientific collaboration between regulators, governments, industry and patients and intensify our communication with EU citizens”, he concludes.

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