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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NEW AIFA DISPOSITIONS ABOUT THE TIMING FOR THE SUBMISSION OF VARIATIONS TO IMPLEMENT PRAC RECOMMENDATIONS
AIFA recently published a new press release with some clarifications on the timing for the submission of variations to implement PRAC…
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CLINICAL TRIALS – ENTRY INTO FORCE OF REGULATION (EU) 536/2014 AND CLINICAL TRIALS INFORMATION SYSTEM
The European Commission has confirmed that the entry into force of the Clinical Trials Regulation (EU) No 536/2014 and the…
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ADVANCED THERAPY MEDICINAL PRODUCTS IN ITALY
ATMP (Advanced Therapy Medicinal Products) are medicines for human use that are based on genes, tissues or cells and offer…
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RPIS IN PIPS AND WAIVERS
The use of the research product identifier (RPI) is used to make EMA processes more efficient by creating a single…
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