THE NEW EUROPEAN PORTAL FOR CLINICAL TRIAL SUBMISSION (CLINICAL TRIAL INFORMATION SYSTEM – CTIS)

As of 31st January, 2022, the Clinical Trials Information System (CTIS) has gone live and thus the Clinical Trials Regulation…

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EMA PRIME SCHEME: 5 YEAR REVIEW (2015-2021)

On 3rd March 2022 the European Medicines Agency (EMA) released the 5-years report for its PRIME (PRIority MEdicines) scheme, that…

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NEW AIFA P&R E-DOSSIER PLATFORM – STATE OF THE ART

Following the provisions of the Ministerial Decree of 2 August 2019 “Criteria and methods by which the Italian Medicines Agency…

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MEDICAL DEVICE CLASSIFICATION – FOCUS ON MEDICAL DEVICE SOFTWARE (MDSW)

The Regulation 2017/745 (MDR) introduced several news for software classified as Medical Devices (Medical Device Software, MDSW).Classification Rule 11 and…

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ADVERTISING OF MEDICAL DEVICES FOR GENERAL PUBLIC

The Competent Authority for the evaluation of the advertising concerning medical devices in Italy is the Ministry of Health (MoH)….

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CLINICAL TRIALS – TRANSITIONAL OPERATING PROCEDURE FOR CLINICAL TRIALS IN ITALY ACCORDING TO REGULATION (EU) NO. 536/2014

With the activation of the CTIS on January 31st 2022, Clinical Trials Regulation (EU) no. 536/2014 has officially entered into…

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SCIENTIFIC ADVICE ON MEDICINE REPURPOSING

The European Medicines Agency (EMA) and National Competent Authorities (NCA) are working on a pilot project to offer scientific advice…

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THE EPI PROJECT

In March 2017, the European Commission (EC) published its report on current shortcomings in the summary of product characteristics (SmPC)…

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EMA LAUNCHES THE REGULATORY SCIENCE RESEARCH NEEDS INITIATIVE

In December 2021, the European Medicines Agency (EMA) published a list of regulatory science topics that require further research efforts…

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CLINICAL TRIALS – REGULATION (EU) 536/2014

The clinical trials evaluation system in Europe will face a radical change starting from January 31st, 2022, with the full…

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