The Italian Medicines Agency (AIFA) has announced that, as of 22 July 2015, it makes available on its website the Public Assessment Reports (PARs) of medicinal products authorised in Italy through the national procedure.
For the medicines authorised from 2015 onwards, AIFA will publish the full PARs together with a summary understandable to a lay person. While for the medicines authorised before 2015, AIFA will only publish a summary of the PARs. All PARs will be published after redacting all commercially confidential information.
Importantly, together with the PAR of a generic product AIFA will publish a summary of the PAR of the reference product. If the latter is centrally approved or approved through the mutual recognition/decentralised procedure, AIFA’s website will include a link to the website of the European Medicines Agency and the Reference Member State, respectively.
AIFA also publishes, since a few years, the PARs of the products for which it acts as the Reference Member State, but not those of products for which it is a Concerned Member State.
This initiative intends to introduce more transparency in the regulatory assessment of medicinal products, in line with similar policies introduced at EU level by the European Medicines Agency.