PHARMACOVIGILANCE – MANAGEMENT OF REPORTS OF LACK OF EFFICACY IN THE NATIONAL PHARMACOVIGILANCE NETWORK

The Italian Medicines Agency (AIFA), in line with what is reported in the Guideline on good pharmacovigilance practices (GVP) Module…

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SCIENTIFIC RECOMMENDATIONS ON CLASSIFICATION OF ADVANCED THERAPY MEDICINAL PRODUCTS

Advanced therapy medicinal products (ATMPs) consist of products that contain recombinant nucleic acids or engineered cells and/or tissues representing a…

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EU REGULATION 2017/745 AND SWITZERLAND

May 26th, 2021 has been the official day for the entry into force of the new regulation of medical devices…

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CONFIDENTIALITY ARRANGEMENT BETWEEN EU AND BRAZILIAN REGULATORY AUTHORITIES

The European Medicines Agency (EMA) and the European Commission’s Directorate-General for Health and Food Safety (DG SANTE) signed a confidentiality…

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ADVERTISING OF MEDICINES TO HEALTHCARE PROFESSIONALS AND TO GENERAL PUBLIC IN ITALY

According to the Legislative Decree 219/06, it is possible to develop promotional material for Healthcare Professionals (HCPs) and for general…

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ONCOLOGY NETWORKS ACTIVE IN 17 REGIONS IN ITALY

At the end of 2020, 20/21 Italian Regions, activated a Cancer Registry and 17/21 formalized a governing body of the…

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REIMBURSED EARLY ACCESS TO UNAUTHORISED MEDICINAL PRODUCTS OR THERAPEUTIC INDICATIONS IN ITALY: UPDATES ON THE PROCEDURE AS PER LAW 648/96

In Italy, law 648/96 allows NHS funding for the use of unauthorized medicinal products or for off-label indications of authorized…

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MEDICAL DEVICES – THE ITALIAN MOH MEDICAL DEVICE DATABASE WITH THE MDR ENTRY INTO FORCE

The Regulation EU 2017/745 (MDR) will enter into force in one month and with it the European database EUDAMED will…

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BREXIT: HOW DOES THIS PHENOMENON AFFECT MARKETING AUTHORIZATIONS IN ITALY?

It is now well-known that, following the Withdrawal Agreement between the United Kingdom and the European Union, the United Kingdom…

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DRUG DEVELOPMENT OPTIMIZATION USING MODELLING METHODOLOGY

Modeling and simulation are a proven scientific approach used to inform crucial drug development decisions. Specifically, scientists from the FDA…

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