Between 13 and 16 December, the Italian Medicines Agency was evaluated as part of the fifth cycle of the benchmarking program of the European regulatory agencies (BEMA - Benchmarking of the European Medicines Agencies).

This evaluation represents the opportunity to identify the strengths and any potential for improvement: the Agencies are encouraged to put in place good practices to enable a better functioning of the European regulatory system. The assessment is based on the systems and processes implemented by the individual Agencies against a set of agreed indicators in the following areas: management systems, assessment of applications for the marketing authorisation of medicinal products, pharmacovigilance and drug safety activities and inspection activities. The BEMA aims to contribute to the development of a global medicines regulatory system based on a network of Agencies that operate according to the standards of good practices.

In this context, the strengths of AIFA were highlighted and confirmed in relation to the areas covered by the performance indicators, i.e. the high quality and technical-scientific competence, contributions to the international network, inspection activities and relations with stakeholders, also with reference to the recent COVID-19 pandemic crisis.

The Agency has obtained a very positive evaluation, higher than that of the previous BEMA (2014), testifying to the profuse commitment to guarantee increasingly efficient processes capable of meeting the growing responsibilities to which Regulators have been called in recent years with regard to public health protection.