A Guide to Early Access: Navigating Named Patient Sales, Compassionate Use & EAMS What happens when a promising medicine is approved in one country (like the US) but not yet in the UK or EU? For patients with high unmet needs, waiting is not always an option. This is where ‘early access’ pathways come in….
Orphan Drug Designation: A Strategic Guide to the EU & UK Pathways For companies developing treatments for rare diseases, Orphan Drug Designation (ODD) is one of the most powerful strategic assets available. It’s not just a label; it’s a critical tool that unlocks significant financial and regulatory incentives. However, following Brexit, navigating the ODD landscape…
PRIME vs. ILAP: Comparing the EMA and MHRA’s Expedited Pathways For pharma and biotech companies, speed to market is critical. Both the European Medicines Agency (EMA) and the UK’s MHRA offer powerful expedited pathways to support the development and review of promising new medicines. These schemes (PRIME from the EMA and ILAP from the MHRA)…
MHRA Post-Brexit: 3 Key Challenges for Pharma in 2026 The UK’s post-Brexit regulatory landscape is no longer a future concept—it’s a present-day reality. As we approach 2026, the full implications of the UK’s standalone regulatory framework are becoming clearer, and companies must be prepared. The separation from the EMA has introduced new pathways, but also…