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GMP Pharmaceutical

The importance of GMP audits for Human and Vet drug manufacturing

The verification of the compliance with the regulations in force, in particular with the Good Manufacturing Practice (GMP), Eudralex vol.4,...

Drug Shortages

Managing shortages between regulatory obligations and patients’ protection

The market shortage of medicinal products is now a global issue, that is continuously discussed by regulatory authorities and trade...

Self-medication drugs, new AIFA guidelines for no prescription drugs and OTCs

A new decree of the Italian Medicine Agency is in the process of being published in the Official Journal, laying...

Italian Classification of Medical Devices: new CID adopted

On 13 February 2026, Decree 29 December 2025 was published in the Official Journal of the Italian Republic, including the...

pharmaceutical-packaging-design-regulatory

Why Healthcare Product Graphics can’t disregard Regulatory Requirements

In the world of health and wellness, a graphic error is not only an aesthetic issue: it’s a legal and...

GMP Veterinary

New GMP for veterinary medicinal products

The European Commission recently published the implementing regulations for the good manufacturing practice (GMP) for veterinary medicinal products and active...

Conventions, Congresses and Meetings Authorisation System: Procedure Updated

New technical functions are operative in the Conventions, Congresses and Meetings Authorisation System as of 19 January. This update has...

EUDAMED: First 4 modules

EUDAMED: First 4 modules become operative. Obligations as of May 2026

EUDAMED, the unique database of medical devices, introduced by the European Commission, is slowly finding its final form, thus leading...

MHRA New Guidance

MHRA Publishes New Guidance Introducing Annual Device Registration Fee

Just a few days ago, the Medicines & Healthcare products Regulatory Agency (MHRA) published a new guidance document titled “Preparing...

Ema database Update

EMA database update: novelties for XEVMPD and PMS, expiry dates and support for MA holders

The European Medicine Agency (EMA) has introduced some important novelties for the management of drug regulatory data, starting the switch...