Observatory for digital health technologies in Europe
The European Commission ’s new report, 'Observatory for Digital Health Technologies in Europe' emphasises the transformative impact of digital health technologies across the EU.
Policy
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NAMs and the European Biotech Act: A Strategic Opportunity for In Silico Medicine
A recent event at the European Parliament brought renewed attention to the growing role of NAMs highlighting the forthcoming European Biotech Act as a major opportunity to accelerate the transition toward non-animal science while strengthening Europe’s global competitiveness.
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EMA launches pilot for model-informed drug development scientific advice
The European Medicines Agency (EMA) has introduced a dedicated pilot procedure for scientific advice and protocol assistance on model-informed drug development (MIDD) — a significant step forward for the in silico community and a clear regulatory signal that quantitative modelling evidence is coming of age.
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VPH at RAPS EURO CONVERGENCE 2026 – Navigating the future of regulation
Our scientific officer, Janaki Raman, joined the global regulatory affairs community in Lisbon for RAPS Euro Convergence 2026 — and in silico medicine was firmly on the agenda.
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Incorporating Patient Preference Information Across Product Life Cycle
The U.S. Food and Drug Administration (FDA) has released updated guidance aimed at strengthening how patient perspectives are incorporated into medical device decision-making throughout the total product life cycle.
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EU Public Consultations Relevant to Our Community
Three important European consultations are currently open for feedback. These initiatives represent key opportunities to help shape policy and regulatory frameworks impacting research, innovation, and healthcare across Europe.
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FDA hits first milestone in plan to phase out animal testing
The U.S. Food and Drug Administration (FDA) has reported the successful achievement of its first-year objectives aimed at reducing animal testing in drug development, representing a notable milestone for the in silico medicine community.
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Launch of ISO-IEC JWG 14 to Advance In Silico Standards for Medical Devices
On 03 February 2026, following the successful approval of the new work item in 2025, the newly established ISO-IEC Joint Working Group 14 (JWG 14) has officially commenced its activities.
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EMA advances 3Rs in regulatory testing
The agency’s 3Rs Working Party published its biennial report for 2023–2024, highlighting progress in promoting alternatives to animal testing while safeguarding scientific quality and animal welfare.
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FDA Releases Key Guidance Updates
The U.S. Food and Drug Administration (FDA) has recently published several guidance documents and policy updates that clarify and modernize regulatory expectations across digital health, medical devices, real-world evidence, and clinical trial design.
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EU MDCG Publishes Key 2025 Guidance on Breakthrough Devices and Post-Market Surveillance
The European Union’s Medical Device Coordination Group (MDCG) has issued two important guidance documents in late 2025, providing clarity and support for stakeholders navigating the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) frameworks.
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Guiding Principles of Good AI Practice in Drug Development
The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have jointly established new AI principles in drug development to reduce regulatory divergence.
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