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The latest European and UK regulatory intelligence. We bring you new and interesting approvals; fast-to-market applications, orphan designations; paediatric applications and therapy area-specific news.
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How will the revised pharmaceutical legislation change orphan-designated medicines for rare diseases?
Comparing EU, UK and US Regulatory Approaches to Orphan Drugs
EMA, MHRA, and FDA: A Comparative Guide to Orphan Drug Regulations and how they affect medicine developers.
The EMA’s new fees: What does the new fee regulation mean for medicine developers?
The fees payable to the EMA will follow the current legal framework until December 31st, 2024. Then, as of January…