Increase in EU drug approvals

EMA Highlights by Gary Finnegan – The number of new medicines approved in the European Union is rising year-on-year, according to the European Medicines Agency (EMA).

In its annual report, the regulator said its Committee for Medicinal Products for Human Use (CHMP) recommended 81 medicines for human use for marketing authorisation in 2013, compared with 57 in 2012.

The number of medicines containing a new active substance has continuously increased for the past three years. The number of generics is stable compared with 2012 but has been generally decreasing over the last few years, according to the report.

Two new advanced-therapy medicinal products (ATMPs) were recommended for approval in 2013, bringing to four the total number of ATMPs recommended for approval by the agency since the legislation on advanced therapies became operational.

The number of recommendations for approval of medicines for rare diseases is steadily increasing with eleven orphan medicines recommended in 2013 compared with eight in 2012 and four in 2011.

2013 also saw the first two positive opinions for marketing authorisations of biosimilar monoclonal antibodies.

The annual report also highlights a number of other changes that have had a profound impact on the Agency and the way it operates. These include the EMA’s commitment to give access to clinical trial data submitted to the Agency as part of a marketing authorisation application, and the stronger interaction with health-technology assessment bodies to facilitate patients’ access to medicines.