INFARMED hosted for 2 days another HMA meeting that gathers the heads of the medicine’s national agencies of the EU member-states. The meeting was organized under the scope of the Portuguese Presidency of the Council of the EU and was focused on the update of current issues, the assessment of implementation of new legislation and get first-hand information on innovative initiatives set on improving European healthcare.
The participants debated, throughout last Tuesday and Wednesday, the new tenure of EMA, the implementation of the Pharmaceutical Strategy for Europe and the negotiation of the regulatory proposal about Health-Technology Assessment (HTA).
The network also dedicated special attention to a set of projects focused on the development of new and innovative technological tools, such as the Central Electronic Submission Portal (CESP), the ePI (Electronic Product Information) and the Darwin EU.
Within the current issues discussed, the fight against COVID-19 was paramount, focusing on the measures taken by the EC. The initiatives resulting from Brexit were also on the table as well as the dissolution of taskforce created to that effect. The meeting also evaluated the changes forced by the new legislation on the Vet area.
The Heads of Medicines Agencies (HMA) is a network of the heads of the National Competent Authorities (NCA) whose organisations are responsible for the regulation of medicinal products for human and veterinary use in the European Economic Area. The HMA co-operates with the European Medicines Agency (EMA) and the European Commission in the operation of the European medicines regulatory network and it is a unique model for cooperation and worksharing on statutory as well as voluntary regulatory activities.
INFARMED is responsible for the coordination of 20 meetings of the various Committees and Working Groups.