The European Medicines Agency (EMA) has recently published the annual report 2014focused mainly on drug evaluation, research support and the development of new innovative medicines. Among the main data that emerge from the report it is emphasized that, last year, the Agency recommended themarketing authorization for 82 new drugs for human use. Furthermore, the EMA stated that, compared to 2013, the number of requests for orphan designation increased by 63%, while requests for scientific advice for medicines for human use increased by 16%.
The annual report also highlights some of the major projects the Agency carried out in 2014 with the aim of introducing a greater transparency and to facilitate patients' access to the best medicines, such as the adoption of the EMA policy on the publication of clinical data, the launch of a pilot project on adaptive pathways, the involvement of patients in discussions on the benefits and risks of medicines evaluated by the Committee for Medicinal Products for Human Use (CHMP); and finally, the implementation of several new legislation.
The EMA has also published a relationship on the findings of the detailed analysis of applications for marketing authorization for new medicines submitted to the Agency from 2008 to 2012. The report shows that scientific advice provided by EMA in the early stages of drug development, starting from the design of the clinical trial, increases success rates and reduces the overall time and scope of objections found during the evaluation of the submitted dossiers.
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he report demonstrates how the scientific advice that EMA, through its Scientific Advice Working Group (SAWP), provides to companies during the development of a drug represents an important aid for the planning of scientifically valid and capable studies to generate adequate data for the benefit-risk assessment by EMA's Committee for Medicinal Products for Human Use (CHMP). In fact, pharmaceutical companies that modified their clinical development plans in accordance with EMA recommendations were more likely to obtain marketing authorization for their medicines.
The EMA reiterates that the advice provided by the SAWP, given that it offers theopportunity to start a scientific dialogue with pharmaceutical companies on all aspects of the development of a medicinal product, including the design of the clinical trial, should be requested by the companies themselves sufficiently in advance to guarantee the implementation of any changes.
For more information on the news, consult the website Orphanet.
