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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MARKET ACCESS – NEW GUIDELINES ON PRICING AND REIMBURSEMENT DOSSIERS OF MEDICINAL PRODUCTS
With Resolution no. 1372/2020, published on its institutional website on 30/12/2020, AIFA has adopted the consolidated version of the new…
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