AIFA plays an assertive role in the regulatory sector of medicines for human use both in Europe and outside Europe.

In Europe, the Agency dynamically contributes to the scientific evaluation activities performed at the European Medicines Agency (EMA) through its scientific committees and related working groups; AIFA participates in the meetings of the working groups of the other EU institutions and takes an active part in the Network of the Heads of Medicines Agencies (HMA). With a view to carry out its activities within the EMA, the Agency makes use of both carefully selected internal experts and distinguished representatives of research centers, hospitals, academia and learned societies.

AIFA participates with its own staff in training projects promoted by the European Commission and by other regulatory agencies of the European Union. Moreover, representatives of the Agency actively contribute to the meetings of the Committees and Working Groups of the European Commission, the EU Council and the Council of Europe dealing with pharmaceuticals.

AIFA also cooperates with the European Network Training Center (EU NTC) for training and updating activities on important scientific and regulatory aspects, for the benefit of all European Regulatory Agencies.

Globally, AIFA actively participates in the work of important international organisations, including the World Health Organisation (WHO), the International Conference for Harmonisation (ICH), the Pharmaceutical Inspection Co-operation Scheme (PIC/S) and the International Coalition of Medicines Regulatory Agencies (ICMRA).

Collaborative relationships with both EU and non-EU countries are regulated by specific bilateral agreements. Furthermore AIFA, in collaboration with the Ministry of Health, participates in the initiatives promoted by the Ministry of Foreign Affairs aimed at stipulating agreements with third countries.

EMRN and Global Regulatory Cooperation

The European Medicines Regulatory Network (EMRN) embraces and actively supports cooperation with regulatory authorities in third countries. This collaboration aims to strengthen global regulatory systems, promote mutual reliance, and enhance public health worldwide.

For direct contact with other National Competent Authorities (NCAs) within the EMRN, please refer to the NCA Contact List on the HMA website, available here.