CHMP Recommended Marketing Authorization for 81 Medicines in 2013

Euro Agency Publishes Annual Report

A total of 81 medicines for human use were recommended for marketing authorization by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), compared with 57 in 2012, according to EMA’s 2013 annual report.

The number of medicines containing a new active substance has continuously increased for the past three years, while the number of generics is stable compared with 2012 but generally decreasing over the last few years, noted 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 CHMP since the legislation on advanced therapies was introduced.

The number of recommendations for approval of medicines intended for the treatment of rare diseases is steadily growing, with 11 orphan medicines recommended in 2013 compared with eight in 2012 and four in 2011. Last year also saw the first two positive opinions for marketing authorizations of biosimilar monoclonal antibodies, successfully applying the biosimilar concept to such structurally complex substances, the authors wrote.

Among the key projects highlighted in the document are the plans to publish and give access to clinical trial data submitted to the agency as part of a marketing authorization application, the stronger interaction with health-technology assessment bodies to facilitate patients’ access to medicines, the agency’s pharmacovigilance activities, and the reorganization of the EMA and the implementation of new legislation.

The full report can be found here.