Navigating rocky animal health regulatory terrain
Plotting a path through veterinary regulations can be fraught with challenges.
To succeed, companies must overcome:
Intricate complexity
Companies with their sights set on market release must contend with many regulatory and guidance documents. Whether dealing with the United States Food and Drug Administration’s Centre for Veterinary Medicine (FDA CVM), the European Medicines Agency Veterinary Medicines Directorate (EMA VMD), or the European Food Safety Authority (EFSA), ensuring compliance with the applicable regulations can be a resource-intensive task, even for the most well-equipped organisations.
Changing requirements
Animal health and food & feed regulations constantly change. To ensure compliance and avoid costly delays, companies must be able to foresee and understand the impact of regulatory updates, which demands deep knowledge and extensive time.
Geographical differences
Regulations and legislations vary in nuanced ways between Europe (EU) and the United States (USA), and the Rest of the World (RoW). Failing to take account of these hard-to-spot regulatory discrepancies can easily derail New Animal Drug Applications (NADA) and Veterinary Medicinal Product Marketing Authorisation (VMP MA) applications, drastically increasing programme costs and delaying all important market entry.
