The Italian Medicines Agency publishes the first document on Regulation and clinical use of haptens for patch testing. The document is divided into two sections, the first one describes the regulation approach of AIFA and the second one shows the revision work of the baseline and additional series carried out by the AIFA Working Group on clinical use of haptens. In the Appendix the revised series are published.

The Agency has outlined a regulation path developed on several areas of intervention, taking into account a constant dialogue with all stakeholders (scientific societies, patient associations, manufacturing companies, European regulatory authorities, Italian Ministry of Health), to identify solutions capable of responding to clinical needs of operators and patients and to legislative and regulatory requests.

The identified approach is based on a transversal strategy to multiple areas of action, in response to different critical issues and needs in the use of the patch testing and has been organised into the following topics.

1.    Authorization on an exceptional and temporary basis of needed haptens in the absence of alternatives authorized by law or with MA (marketing authorisation) (AIFA decision 1334/2021, updated by AIFA decision 98/2022)
2.    Establishment of the AIFA Working Group for the clinical use of haptens for patch testing with the following objectives: i) draft of a shared national Guideline on the clinical use of haptens for patch testing; ii) produce useful evidence for identifying an ad hoc regulatory tool for the clinical use of rare haptens without MA; iii) provide scientific support to the regulatory activities of the Agency.
3.    Draft a quality assurance document for the patch testing extemporaneous preparation
4.    Identification of a classification model for haptens
5.    Draft a guideline on the evaluation criteria of MA dossiers
6.    Active participation in European groups operating in the field of allergen medicines
7.    Identification of ad hoc legislative provisions

The document includes the updated Baseline Series for Adults and Pediatric population and the Additional Cosmetic Series drafted by the AIFA Working Group on haptens. This document will be updated constantly.