The Italian Medicines Agency has published a revision of its ‘Regulation and clinical use of haptens for patch test’, with important updates to the two sections featured in the document.

The first section provides a brief overview of the various activities undertaken by the Agency to regulate the sector with reference to haptens for patch tests. The second section contains new series developed by the Technical Table.

In addition to the revision of the already-published Paediatric Basic Series and the Cosmetics Supplementary Series, Appendix 2 of this new edition includes new supplementary series developed so far: Dental, Orthopaedic, Hairdressing, Lip, Eyelids, and (Meth)Acrylate Supplementary Series. 
Appendix 3 contains the list of haptens for the diagnosis of ACD to topical medicines.

The updated series take into account, for the first time, not only the updates of the reference literature, but also the regulatory process underway at the Agency, and are shared by all the reference scientific societies, represented in the AIFA Technical Table on the clinical use of haptens for patch tests, established in 2022.

The work of reviewing and updating the Series represents only one stage of the path outlined by the Agency and which sees Italy among the first European countries to work on the systematic regulation of the allergen sector and to propose specific legislative and regulatory solutions, which may be of valid support in achieving a harmonised approach at European level.