Insights

AIFA has released Version 4.0 of its Q&A document on EU Regulation 536/2014, providing essential operational clarifications for conducting clinical trials in Italy. Below is a summary of the main updates that stakeholders should take into consideration:

🔹 Language requirements – Part I

The protocol synopsis should preferably be submitted in English, while the layperson synopsis must be provided in Italian to ensure accessibility for trial participants.

🔹 Informed consent in bilingual regions

For clinical sites located in regions where bilingualism is protected by law, informed consent forms must be submitted in both official languages, along with a certified translation. If not available during submission, ethics committees may issue a conditional approval pending later submission as a non-substantial modification.

🔹 Site suitability requirements

National provisions on site suitability remain unchanged. A written declaration by the site director must confirm the adequacy of infrastructure, equipment, human resources, and expertise, as required by Annex I of the Regulation.

🔹 Advertising and recruitment material

Sponsors may publish recruitment materials via any channel, but all content must be uploaded to CTIS and formally authorized. Information must be consistent with the EU database and must not have promotional intent.

🔹 Labelling of authorized medicinal products

Medicines with valid marketing authorization may be exempt from additional labelling unless required by the protocol (e.g. for blinding or safety reasons). This applies whether the medicine is provided by the sponsor or procured by the trial site.

🔹 Home delivery of investigational medicinal products

When re-labelled and/or repackaged by a hospital pharmacy, investigational products may be delivered directly to patients by the investigator for home use. In such cases, qualified site staff must ensure the patient is adequately trained in handling and storing the medication.

These clarifications strengthen the alignment between EU and national frameworks, supporting a more efficient and compliant approach to clinical trial management in Italy.

RPN will provide any further update and is available to provide full support for Clinical Studies activities.