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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PILOT PROGRAM EMA-FDA PARALLEL SCIENTIFIC ADVICE FOR HYBRID/COMPLEX GENERIC PRODUCTS
The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) have established a pilot program, starting from…
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COMMUNICATION AND ADVERTISING FOR OTC AND SOP MEDICINAL PRODUCTS IN ITALY
Communication and advertising activities for OTC and SOP medicinal products addressed to the public are subject to specific rules, with…
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CONVERTING CENTRALLY AUTHORISED PRODUCTS (CAPS) TO UK MARKETING AUTHORISATIONS (MAS)
After Brexit became effective on 1st January 2021, all existing EU product MAs obtained through Centralized procedure (CAP) have been…
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SWISS AUTHORISED REPRESENTATIVE – INFORMATION FOR DISTRIBUTORS AND IMPORTERS: AN UPDATED GUIDANCE DOCUMENT FROM SWISS MEDTECH
Following the entry into force of the EU Regulation 2017/745 on medical devices in May 2021 and following the failure…
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IMPD GUIDELINE UPDATE
Since clinical trials are often designed as multi-centre studies, potentially involving different Member States, on March 2006 the European Medicines…
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FDA GUIDANCE ON BISPECIFIC ANTIBODY DEVELOPMENT
Bispecific antibodies (bsAbs) are genetically engineered, recombinant antibodies having two distinct binding domains capable of binding two different antigens or…
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