The report described the continuous approval of vaccines in view of the 2020 attack, Kovid -19, strengthening cyber -capacities and expansion of the agency’s mandate.
why it matters
In 2021, the European Commission, Parliament and the Council gave more and more equipment to the EMA, which to support it innovation and respond to emergency situations, an acknowledgment of the agency’s important role in dealing with the epidemic, reply to the emergency Was able to give.
EMA approved five remedies and four new vaccines against Covid-19. It also passes the regulation on medical devices – compared to planned a year later – and take steps towards developing an information network designed to generate data about health patterns in the continent, which, which is taken, which which Data analysis and real world inquiries are called Network (Darwin EU). ,
But 2021 was a challenging year for Europe’s medical regulator. A lesson–ignited exercise on the reaction of Covid-19, said EMA needs to improve the collection and coordination of health data and increase data analytics so that public belief in vaccines and other drugs between other conclusions Could
The introduction of the report states, “Due to its important role in the global response to epidemic, EMA found itself in public and media attention during 2021.”
On record
Beyond his response to the epidemic, Digital Development was central in agency activities. It established a laboratory for Digital Innovation, The Digitalib, how to find out how AI, machine learning and robotics can improve internal functioning. Darwin EU is a major initiative, aimed at exploiting the power of data in the decision making of EMA and underlines the efforts of other European Union such as European health data space. In 2021, the EMA created the advisory board of the Darwin EU and took other steps towards developing the project.
The outgoing chairman of the EMA of the Management Board Christa Writer-Hoshe said that Darwin EU was an example of exploiting the power of data analytics to support the drug regulation. “
Take them
The agency experienced some challenges of digital changes in a cyber-halle in December 2020, causing emails leaked and personal data was accessed. According to the report, an inquiry was initiated quickly in collaboration with the European Union Computer Emergency Response Team (CERT-EU) and Europol’s Dutch police. “Criminal infiltration was successfully contained in the EMA’s IT system. The agency and the European medicine regulatory networks remained completely functional, and the timelines related to the evaluation and approval of Covid-19 vaccines and treatments were not affected. ,
Further, the EMA needs to take steps to ensure that beyond Kovid -19, it is “fit to deal with scientific and technical challenges.”
This will include Cook celebrated, future unknown and emerging health threats.
