International Relations

AIFA intends to strengthen its International relations in order to allow Italy to take on an influential and prestigious role within the EU.

This will be achieved through two objectives:

Improve the performance of Italy as a RMS in the Mutual Recognition and Decentralised authorisation procedures.
Provide an increasingly substantial scientific contribution as rapporteur-country in the Centralised authorisation procedures with a focus on innovative drugs and orphan drugs.

AIFA supports the development of regulatory activities of the candidate countries and of the new countries joining the EU. Specifically, AIFA coordinates the active participation of its representatives to the European Medicines Agency (EMA) regarding the assessment process of the most innovative pharmaceutical products to be put on the Community market. For this reason, coordination of the experts who interact in the International fora is fundamental. They participate as members of Working Groups or as national representatives in the European Committees where Italy is a permanent member:

CHMP-Committee for Medicinal Products for Human Use
COMP-Committee for Orphan Medicinal Products
HMPC-Committee on Herbal Medicinal Products; CAT-Committee on Advanced Therapies.

AIFA actively follows and attends the international bodies’ work, such as EDQM (European Directorate for the Quality of Medicines) and the PIC/s (Pharmaceutical Inspection Co-ordination Scheme). AIFA takes part in the activities of the HMA (Heads of Medicines Agencies) which manages the non-centralised activities on drugs in the European regulatory system through its numerous initiatives and its working groups. The experts who attend the above mentioned Groups and Committees are not only staff of the Agency but also authoritative representatives of research centres, hospitals, academia, learned societies.

Internationally, the Agency seeks bilateral collaboration with organisations and agencies in strategically relevant areas.

Finally, the Agency also promotes knowledge by internal dissemination of experience achieved within European and International fora, with a view to stimulate new interactions between the various external partners of AIFA (University, Industry, Scientific Community) and promoting cultural and operational exchange in Italy and abroad.

Contacts