On Tuesday, the EMA has published its Regulatory Science Strategy to 2025. The strategy provides a plan for advancing regulatory science over the next five years, covering both human and veterinary medicines.
The five key goals of the strategy include: catalysing the integration of science and technology in medicines development; driving collaborative evidence generation – improving the scientific quality of evaluations; advancing patient-centred access to medicines in partnership with healthcare systems; addressing emerging health threats and availability/therapeutic challenges; and enabling and leveraging research and innovation in regulatory science.
Update: the voting sheet is now available.
The Committee was consulted from 26-27 March 2020 on temporary measures to contain risks to human, animal and plant health and animal welfare during certain serious disruptions of Member States’ control systems due to Coronavirus disease (COVID-19).
Data on the presence of residues of veterinary medicines and contaminants in animals and animal-derived food show high rates of compliance with recommended safety levels in the European Union, according to EFSA’s latest report. The report summarises monitoring data collected in 2018.
EMA has implemented a new system to issue electronic certificates for human and veterinary medicines. As of today, the Agency will no longer provide printed certificates but only electronically signed and authenticated certificates to maintain EMA’s ability to provide these documents during the COVID-19 pandemic.
In the last ten years, 22 new veterinary medicines for minor uses and minor species (MUMS) have been authorised through the centralised procedure by EMA. This is largely the result of the MUMS/limited market policy for the classification of veterinary medicines established by the Agency in 2009.