EMA management board report: COVID coping, CTIS updates and more

Regulatory NewsRegulatory News | 21 June 2021 |  By 

The management board of the European Medicines Agency (EMA) gave a generally positive assessment of the agency’s work through the COVID-19 pandemic, according to recently released highlights of the board’s June meeting.
The board has begun the process of conducting a formal reflection on lessons learned from the pandemic, with a more detailed discussion expected when the board reconvenes in October.
EMA’s board also reviewed the agency’s 2020 annual report published earlier in June. “The Board noted that although 2020 had been another challenging year for EMA due to the COVID-19 pandemic, the Agency had managed to maintain the high quality and continuity of its core operations whilst also completing the relocation to its permanent headquarters in Amsterdam,” noted the board’s announcement.
In non-pandemic matters, the board applauded EMA’s contributions to global efforts against antimicrobial resistance and new publications related to regulatory science and network strategies. Also noted were EMA’s concerns regarding staffing levels “in light of its continuously increasing workload” and the potential expansion of EMA’s role. (RELATED: Brexit, COVID-19 headline EMA’s 2020 annual report, Regulatory Focus 14 June 2021)
Another area of progress identified by the board was preparation for the “go-live” of the Clinical Trial Information System (CTIS). The EC decision on the CTIS should be published by the end of July, keeping the project on track for a go-live date of 31 January 2022. “It is now vitally important that stakeholder organizations, clinical trial sponsors and authorities, prepare their staff and processes to work with CTIS to make use of the strengths that the system and the legislation will bring to their activities,” wrote the board. (RELATED: EU clinical trial portal and database declared functional, Regulatory Focus 21 April 2021)

A more agile system to support EMA network IT systems is in the works, and the EMA board heard a presentation detailing how telematics governance will be updated. The board endorsed a pilot of the new support system, which will kick off this summer, beginning a transition that is expected to continue through 2022.
The cybersecurity breach of EMA’s vaccines data was also reviewed at the June board meeting. Though that intrusion was contained, EMA is now reviewing its information security strategy, ”with the aim of putting into place a three-year improvement road map in line with best practices for similar organizations.”
Veterinary medicines fees were also revised and will be updated early in 2022.
EMA management board


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