European Pharmaceutical Reform: Key Changes Introduced by the Pharma Package
On 28 September 2026, the Council of the European Union approved the new Pharma Package, marking an important milestone in…
Focus
ISO 9001:2026 – How to prepare for the change?
On September 16, 2026, the new edition of ISO 9001 was published.This is not a complete rewrite of the standard,…
e-IFU: it is not simply an IFU converted into a PDF
The evolution of the European regulatory framework is opening up new opportunities for the use of electronic Instructions for Use…
Adaptation of the Central Database to the European Regulatory Framework
The Decree of 16 June 2026 was published in the Official Gazette, updating the operating procedures of the Central Database…
EUDAMED: The Next Deadline Is Fast Approaching. Are Manufacturers Truly Ready?
Starting from 28 May 2026, the Actor, UDI/Devices, Notified Bodies & Certificates, and Market Surveillance modules became mandatory. For many…
PPWR – What changes for companies and how to prepare
On 12 August 2026, one of the first operational deadlines of Regulation (EU) 2025/40 (PPWR) will come into force. For…
From Complaint to Reporting: The New Operational Workflow of the Italian Ministry of Health
With Circular No. 59712 of 21 July 2026, the Italian Ministry of Health introduced a new digital system for managing…
Published the 22nd AIFA National Report 2025 on Clinical Trials of Medicinal Products in Italy
The 22nd AIFA National Report 2025 on Clinical Trials of Medicinal Products in Italy provides an updated snapshot of the…
Implantable devices and class III devices: Delegated Regulation (EU) 2026/1451
With the publication of Delegated Regulation (EU) 2026/1451, the European Commission expands the list of implantable devices and class III…
National HTA Medical Device Program (PNHTA‑MD) 2026–2028
Technological innovation must advance hand in hand with sustainability and clinical validation. This Focus examines the National HTA Programme for…