EMA Executive Director Sends Message of Promoting Stronger Public Presence for Safety, Efficacy of Medicines

Emer Cooke, the executive director of the European Medicines Agency (EMA), shared her optimism for the new year ahead, considering the multiple changes and challenges that the COVID-19 pandemic has brought since it started.

Cooke highlighted how seven COVID-19 vaccines and four vaccines tailored to the specific strains of the SARS-CoV-2 virus were authorized for use in the European Union since the start of the pandemic, bringing the population to a much better place than previous years.

“Thanks to the rapid pace of scientific progress, and to EMA’s and the regulatory network’s ability to adapt during these times of crisis, we are able to experience some return to normality again,” Cooke said in a press release. “The knowledge we gained with COVID-19 also helped us mount a rapid response to mpox (monkeypox), declared a public health emergency by the World Health Organization (WHO) in the middle of the year.”

Additionally, 89 human medicines have been recommended for approval by the EMA, and the organization also analyzed a new vaccine against dengue and two diabetes treatments that address important public health issues outside the EU.

Cooke recognized EMA’s efforts and successes during the pandemic, with an extended mandate that helped formalize their existing procedures and provided new tools to respond effectively to future public health crises, tackled medicine shortages, and improve the monitoring of medical devices and their authorization procedures.

She also mentioned the Clinical Trials Regulation and the Clinical Trials Information System (CTIS) launching at the same time to help energize the clinical research area of the EU.

“It is a major change management initiative, a move from an entirely national system 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,” Cooke said in a press release. “We are working hard to deliver the next CTIS milestone: the mandatory use of the system as of 31 January 2023.”

Cooke concluded that she hopes to continue supporting a work environment that prevents burnout and promotes the wellbeing of all staff members. This can range from listening directly to staff feedback, personal challenges, and struggles that help apply the best approaches.

Source: European Medicines Agency