Bringing medicine back to life?

The European Medicines Agency (EMA) scientific advice procedure is designed to enhance communication between sponsors and regulators, streamlining the development of high-quality medicinal products. Preparing a clear and well-structured briefing document is key to obtaining meaningful feedback. This document includes the product’s development program, precise questions for advice, and evidence-backed applicant position statements that consider alternative approaches and proactively address potential concerns.

Drug development is a long, expensive, and risky process. It takes an average of 10-15 years and requires a multi billion investment to bring a new drug from the laboratory to patients.

Orfenix welcomes a recently published report of the Medicines Patent Pool, in partnership with Boston Consulting Group, shows how voluntary licensing brings both improved access to medicines, in particular in low and middle-income countries and economic benefits to the companies doing the out-licensing.