API Documentation: Navigating the ASMF (formerly DMF) in EU/UK Submissions The Active Pharmaceutical Ingredient (API) is the heart of any medicinal product. Providing its quality documentation is mandatory, but for API manufacturers, protecting the proprietary ‘know-how’ (intellectual property) is paramount. This is where the Active Substance Master File (ASMF) comes in. Formerly known as the…
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)…
A Practical Guide to SAHPRA Submissions in South Africa As the most developed economy in Southern Africa, South Africa is a critical market for pharmaceutical and biotech companies. The regulatory body, the South African Health Products Regulatory Authority (SAHPRA), has undergone significant transformation, moving away from the old MCC framework to a more modern, efficient…
A Practical Guide to NAFDAC Submissions in Nigeria Nigeria, with its large population and growing healthcare sector, is a key strategic market for many pharmaceutical and biotech companies. However, navigating the regulatory landscape, managed by the National Agency for Food and Drug Administration and Control (NAFDAC), requires deep local knowledge. The process has its own…
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…
Navigating the EMA’s New PRIME Guidance: What’s Changed? The EMA’s PRIME (PRIority MEdicines) scheme is one of the most valuable accelerated pathways in Europe, offering enhanced support for medicines that target an unmet medical need. Recently, the EMA released new guidance and updates to the scheme. While the core benefits remain, the changes refine the…