EMA Pre-authorisation guidance (Human Regulatory)

July 19, 2022

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July 8, 2022

Orphan Drug Designations in the U.S. and EU

What is an Orphan Drug Designation? The Orphan Drug Designation (ODD) program in both the United States (U.S.) and European Union (E.U.) qualifies sponsors to receive potential incentives to develop...

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July 20, 2022

5 Benefits of Receiving EU PRIME Designation for Medicine Developers

What it is, why it matters, how you can apply and how we can help. What is the PRIME Scheme? You might be forgiven if you don’t know what the PRIority MEdicines (PRIME) scheme is; but if you are in...

April 26, 2022

Facilitating global access to diabetes treatments for non-EU patients Share

April 22, 2022 EMA’s human medicines committee (CHMP) has given a recommendation for two diabetes mellitus treatments, Actrapid and Insulatard, for use outside the European Union (EU). EMA is...