Brexit: EMA prioritises Activities

Recommendation

27/28 October 2021

GMP for Medical Devices - EU versus USA - Live Online

The European Medicines Agency EMA expects some uncertainty and higher workload because of the United Kingdom's withdrawal from the European Union (Brexit). To preserve the Agency's "ability to protect public and animal health", EMA has defined three categories to prioritise activities in a business continuity plan:

• Category 1: Activities which need to be continued to avoid production and distribution risks and a "detrimental effect on the health and well-being of citizens".
• Category 2: Activities which need to be maintained as long as possible to maintain the development of new medicines.
• Category 3: Activities which can be put on hold.

Examples:

Category 1 activities:

• Assessment and safety monitoring of medicines
• Maintaining the infrastructure of the European regulatory system for medicines
• Coordination of actions to protect the safety of patients
• Inspections/ maintenance of critical IT applications used by all Member States

Category 2 activities:

• Proactive publication of clinical data
• Initiatives aimed at promoting availability of medicines
• Fight against antimicrobial resistance
• Interactions with Health Technology Assessment (HTA) bodies

Category 3 activities:

• Development of the European Medicines Web Portal (a new publicly-available online information source on all medicines marketed in the EU)
• Contribution to the e-submission project
• Development of a transparency roadmap
• Participation in the benchmarking of medicines regulatory authorities in the EU
• Participation in external meetings or conferences
• Organisation of EMA meetings and workshops.

Despite the a business continuity plan, EMA is aware that "unexpected higher, faster or more permanent loss of staff as a consequence of the Agency's relocation may lead to a situation in which EMA's operations can no longer be maintained."

Please also see the press release "EMA prepares for Brexit" as well as the activities in the business contiuity plan.