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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IRISH LANGUAGE DEROGATION ENDING ON 1ST JANUARY 2022 AND NEXT STEPS FOR IRISH MARKETING AUTHORIZATION HOLDERS

Following the European Commission report published in June 2021, it was confirmed that no capacity problems are foreseen for translations…

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SPONSORSHIP OF CONGRESSES AND EVENTS

When a pharmaceutical Company (Italian Affiliate or MAH) intends to sponsor a meeting or a congress attended by Italian Healthcare…

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UPDATES FROM THE ITALIAN MOH ON EU REGULATION 2017/745

The EU Regulation 2017/745 on medical devices (MDR) came into force in May 2021 but there are still several points…

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THE ITALIAN DRUG TRACEABILITY SYSTEM

The traceability project put in place by the Italian MoH is an instrument to uniquely identify every single package of…

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