EMA Releases 2016 Highlights

Article

The agency published an overview of marketing authorizations made in 2016.

On Jan. 17, 2017, the European Medicines Agency (EMA) published an overview of the market authorizations and the safety monitoring recommendations the agency made in 2016. EMA recommended 81 drugs for market authorization in 2016, which included 27 new active substances.

Some notable highlights from the report include 16 orphan drug designations in 2016. These drugs treat patients with hematology disorders, cancer, hepatology disorders, immunological problems, and metabolism disorders. There were also accelerated assessments made for authorization of treatments for unmet needs including different forms of cancer and chronic hepatitis C infections.

Source: EMA

Recent Videos
Miguel Forte from ISCT and Kiji Therapeutics talks about the potential impact of a changing European political landscape.
Miguel Forte from ISCT and Kiji Therapeutics provides his insights into the changing political landscape in the US as well as legislative and regulatory adjustments
Miguel Forte from ISCT and Kiji Therapeutics chats about expectations for 2025 and the future technology agenda for industry.
Sheryl Johnson from Orbia Fluor & Energy Materials chats about gender diversity, how women are helping to advance innovation, sustainability challenges, and progress in the field of inhaled drugs.
Mike Baird from Schlafender Hase gives his predictions for how AI and ML may find use in the industry moving forwards and provides some predictions about M&A and the changing US government administration.
Mike Baird from Schlafender Haser discusses industry trends from 2024 and those expected to have an impact in 2025 from the perspective of a software developer.
Preeya Beczek from Beczek.COM gives her thoughts on the areas to watch with the new US administration and how Europe might be finalizing preparations for previous legislative changes