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Innovation in animal health under Regulation (EU) 2019/6: Review and recommendations
Klaus Hellmann1, Helen Jukes1, Matthias Hofer2
1Klifovet GmbH, Munich, Germany.
The EU Veterinary Medicinal Products Regulation (VMPR) impacts animal health innovation, presenting challenges and proposing adaptations for VMPs. Strategic actions are needed to foster novel therapies and sustainability in limited markets.
Area of Science:
- Veterinary Medicine
- Regulatory Science
- Animal Health Innovation
Background:
- The EU Veterinary Medicinal Products Regulation (EU) 2019/6 aims to harmonize veterinary medicinal products across the EU.
- Innovation in animal health is crucial for public health, animal welfare, and sustainable agriculture.
- Stakeholders face significant hurdles in developing and registering new veterinary medicinal products.
Purpose of the Study:
- To evaluate the impact of the EU VMPR on innovation within the animal health sector.
- To identify regulatory, scientific, and commercial challenges affecting VMP development.
- To propose strategic actions for fostering innovation in veterinary medicine.
Main Methods:
- Synthesis of outcomes from an interdisciplinary conference.
- Analysis of expert presentations and panel discussions.
- Review of current regulatory, scientific, and commercial landscapes.
Main Results:
- The EU VMPR presents multifaceted challenges to innovation in animal health.
- Limited markets, novel therapies, and sustainability concerns are key areas of impact.
- Adaptations in regulation and procedures are necessary to support VMP development.
Conclusions:
- The current regulatory framework requires adjustments to effectively support innovation in veterinary medicinal products.
- Strategic interventions are essential to overcome challenges and promote the availability of novel VMPs.
- Fostering innovation is critical for advancing animal health and addressing future needs.
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