CLINICAL TRIALS – UPDATE OF SUBMISSION PROCEDURE AND AUTHORIZATION FORMS
The Italian Medicines Agency (AIFA) has published an update concerning the documentation for the submission of Phase I, II, III…
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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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