Regulation of veterinary medicinal products in the 21st century - PowerPoint PPT Presentation

Regulation of veterinary medicinal products in the 21st century – Addressing challenges and opportunities across the European Regulatory Framework EMA’s Regulatory Science Response Veterinary Stakeholders Workshop Presented by Ivo Claassen on 6 December 2018 Head of Veterinary Medicines Division, EMA An agency of the European Union

Why now? To monitor and sign-post emerging and future trends in science and technology To identify key priorities where new or enhanced engagement is essential to the continued success of the Agency’s mission To prioritise use of resources and external collaborations to strategically advance regulatory science To shape and influence the vision for the EU Medicines Agencies Network (EMRN) Strategy 2020–25 1 EMA’s Regulatory Science Response

How does EMA define Regulatory Science? Regulatory science is defined as a range of scientific disciplines that are applied to the quality, safety and efficacy assessment of ( veterinary ) medicinal products and that inform regulatory decision-making throughout the lifecycle of a medicine. It encompasses basic and applied ( veterinary ) medicinal science and social sciences, and contributes to the development of regulatory standards and tools. 2 EMA’s Regulatory Science Response

The role of regulatory science at EMA? View 1 View 2 Regulatory B/ R assessment science Scientific advice Scientific advice Guidances Guidances B/ R assessment Regulatory science 3 EMA’s Regulatory Science Response

Vision—EMA Regulatory Science to 2025 “ To foster scientific excellence in the regulation of veterinary medicines for the benefit of animal and public health while facilitating and promoting innovation and access to novel medicinal products. ” 4 EMA’s Regulatory Science Response

Industry Academia interview interview WP output output Baseline Chairs mapping mapping report interview output output mapping Vet practitioners SciCoBo review output SCG review output Regulatory Science to 2025 5 EMA’s Regulatory Science Response

Strategic goal 1 To catalyse the integration of science and technology in drug development. Strategic goal 2 To drive collaborative evidence generation to improve the scientific quality of evaluations. Strategic goal 3 To address emerging health threats and availability/ therapeutic challenges. Strategic goal 4 To enable and leverage research and innovation in regulatory science. 6 EMA’s Regulatory Science Response

EMA Regulatory Science to 2025 - Timeline Decem ber 2 0 1 8 Q4 2 0 1 8 June 2 0 1 9 Q4 2 0 1 9 Q1 2 0 2 0 Stakeholders’ Consolidation Critical feed Q4 2018-Q2 2019 workshops workshops into EMRN and Strategy to Public consultation Human & publication 2025 Vet Legislation follows science, not the other way round: embracing innovation ambition beyond implementation of NVR? 7 EMA’s Regulatory Science Response

David Murphy, Nancy de Briyne, Christian Siebert, Chair of CVMP FVE DG Santé Jean-Pierre Orand, Alexander Böttner, HMA Management AnimalhealthEurope Group 8