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Stephanie Sutton was an assistant editor at Pharmaceutical Technology Europe.
An evaluation conducted by Ernst & Young assessing the effectiveness and efficiency of the European Medicines Agency has largely praised the agency; however, a number of strategic and operational recommendations for further improvements have also been made.
An evaluation conducted by Ernst & Young assessing the effectiveness and efficiency of the European Medicines Agency has largely praised the agency; however, a number of strategic and operational recommendations for further improvements have also been made. In particular, the evaluation highlighted the fact that the main committees are "overwhelmed" with work and that consistency between the agency's 35 entities/committees was a "constant challenge".
For the most part, the
of the evaluation painted a positive picture of the agency. "The present evaluation confirms the operational effectiveness of the system as a whole, which is recognised by all internal and external stakeholders," said the report. "It provides with complete, clear and highly valued opinions within regulatory tight deadlines and allows the contribution of the best available experts in Europe, while ensuring the impartiality of assessments."
However, the report also added: "the whole system is progressively attaining its maximum capacity", explaining that the main opinion-making committees, Committee for Medicinal Products for Human Use (CHMP) and Committee for Veterinary Medicinal Products (CVMP), have tremendous workloads and that their agendas can hardly be extended. Consistency between the agency's 35 entities/committees was also identified as a "constant challenge", but there may be ways in which this can be overcome. For instance, the report highlighted concerns in paediatric regulation with regards to potential inconsistencies between the Paediatric Committee (PDCO) and CHMP, but these could be overcome if PDCO were to evolve towards a Pre-committee model, which would reinforce the consistency of the whole system.
To overcome issues relating to work overload, the report suggests that two dedicated committees could be created to deal with referrals and generics. "In addition, working parties organization should also be reviewed; some may be removed, others may be created according to their relevance with regards to the evolution of the scientific research and European medicines agency internal organization."
Another key finding from the report is that the effective distribution of centrally authorised products is an important weakness of the system because many of these products are only available in a limited number of member states particularly when it comes to veterinary products.
Medicines' distribution falls out of the scope of the European Medicines Agency much to the regret of many stakeholders. The report says: "This issue highlights an important challenge for the European authorization system in the coming years: not only regarding the follow up of distribution as a first step, but also through actions or incentives for broader distribution of authorized products in member states, thus contributing to optimize the impact of this system on the European public health."
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