EMA publishes 2013 annual report
In 2013, the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended 81 medicines for human use for marketing authorisation, compared with 57 in 2012.
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.
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 became operational.
The number of recommendations for approval of medicines intended for the treatment of 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, successfully applying the biosimilar concept to such structurally complex substances.
In the veterinary area, the Committee for Medicinal Products for Veterinary Use (CVMP) started the evaluation of a record number of 23 marketing-authorisation applications for new veterinary medicines, almost twice the volume of 2012. More than two thirds of applications are for new immunologicals. The CVMP issued twelve positive opinions for new veterinary medicines, including the first vaccine against foot-and-mouth disease for authorisation at European Union (EU) level.
The annual report also highlights some of the main projects, initiatives and achievements in 2013 that had and still have a profound impact on the Agency and the way it operates. These include the EMA’s commitment to publish and give access to clinical trial data submitted to the Agency as part of a marketing authorisation application, the stronger interaction with health-technology assessment bodies to facilitate patients’ access to medicines, the reorganisation of the EMA and the implementation of new legislation. The document reports in particular on the range of pharmacovigilance activities that have been embedded into the core business of the Agency as part of the implementation of the EU pharmacovigilance legislation.