🚀 The veterinary regulatory landscape is evolving: is your strategy ready for 2026?
🐾 I have just synthesized the critical highlights from the EMA veterinary medicines info day 2026, where over 900 experts gathered to map out the future of our industry. I was particularly struck by the convergence of technological innovation and ethical evolution.
At Sarasvet, we believe that navigating these changes is exactly where science meets conscience. For our partners and SMEs in the animal health sector, here are the 4 major shifts you need to track:
The Biotech Act: accelerating innovation 🧬 The proposed Biotech Act is a game-changer. By streamlining GMO requirements and removing parallel assessments, the EU aims to cut administrative burdens. This means a faster path to market for recombinant vaccines and biotherapeutics.
The 3Rs: from theory to regulatory reality 🔬 A key highlight was the industry perspective shared by @Jyoti Soni-Gupta, president of the AVC. The goal is to reduce ambiguity for developers by fostering a broader acceptance of New Approach Methodologies (NAMs), such as AI-driven models and organ-on-chip technology, in study designs.
Pharmacovigilance: the "gold standard" 🛡️ Retrospective reporting is shifting toward active surveillance. Signal Management is now the official gold standard. With the ongoing revision of the VGVP module, companies must adopt a proactive, data-driven approach to benefit-risk balance.
Ethical science and virtual controls 🌱 The EMA is prioritizing ethical efficiency. The implementation of NAMs—including virtual control groups—is no longer futuristic; it is becoming a standard for transforming regulatory testing into a more ethical process.
💡 Take-home message: The future of animal health is not just about scientific breakthroughs; it is about regulatory agility. Embracing tools like the Innovation Task Force (ITF) early in development and collaborating through expert networks like the AVC will be key to navigating this new era.
Let’s lead the way in creating a positive impact across the veterinary industry. 🌍
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