EMA Lays Out Medical Innovation Strategy

The European Medicines Agency has laid out a strategy to enhance medical innovation over the next five years by adding special regulatory incentives for high-priority diseases.

As active ingredients and clinical trial work continues to ramp up in developing countries, the EMA says it will work with global partners to address challenges posed by complex supply chains, including data integrity.

The document finalizes draft guidance unveiled in March that garnered 380 comments, urging the EMA to better define the concept of unmet medical need and increase emphasis on biosimilars and generic drugs.

The full strategy can be read at www.fdanews.com/12-21-15-EMA2020Strategy.pdf.