PILOT PROGRAM EMA-FDA PARALLEL SCIENTIFIC ADVICE FOR HYBRID/COMPLEX GENERIC PRODUCTS

The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) have established a pilot program, starting from…

READ

COMMUNICATION AND ADVERTISING FOR OTC AND SOP MEDICINAL PRODUCTS IN ITALY

Communication and advertising activities for OTC and SOP medicinal products addressed to the public are subject to specific rules, with…

READ

CONVERTING CENTRALLY AUTHORISED PRODUCTS (CAPS) TO UK MARKETING AUTHORISATIONS (MAS)

After Brexit became effective on 1st January 2021, all existing EU product MAs obtained through Centralized procedure (CAP) have been…

READ

SWISS AUTHORISED REPRESENTATIVE – INFORMATION FOR DISTRIBUTORS AND IMPORTERS: AN UPDATED GUIDANCE DOCUMENT FROM SWISS MEDTECH

Following the entry into force of the EU Regulation 2017/745 on medical devices in May 2021 and following the failure…

READ

IMPD GUIDELINE UPDATE

Since clinical trials are often designed as multi-centre studies, potentially involving different Member States, on March 2006 the European Medicines…

READ

FDA GUIDANCE ON BISPECIFIC ANTIBODY DEVELOPMENT

Bispecific antibodies (bsAbs) are genetically engineered, recombinant antibodies having two distinct binding domains capable of binding two different antigens or…

READ

AIR PURIFIERS AND AIR DECONTAMINATORS: ARE THEY MEDICAL DEVICES OR NOT?

In the context of the COVID-19 pandemic, great attention is given to the sanitation measures of people and environments. People…

READ

FDA GUIDANCE ADDRESSES PATIENT OUTCOMES IN CANCER CLINICAL TRIALS

Involvement of patients is becoming a fundamental principle throughout drug development and during regulatory advice and assessment. Patients have been…

READ

NEW AIFA PRICING AND REIMBURSEMENT E-DOSSIER PORTAL GOES LIVE

A new electronic interface for the preparation of Pricing and Reimbursement e-Dossiers has been developed by AIFA and has become available since 31st May…

READ

5% PAYBACK – LATEST NEWS

In Italy, with a few exceptions, the public price (VAT included) of medicines reimbursed by the NHS is subject to…

READ