REGISTRY OF OBSERVATIONAL STUDIES (RSO) IN ITALY
Starting from January 31st, 2023 the Registry of Observational Studies (RSO) will be activated on the AIFA Portal. The RSO…
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INSTITUTIONAL PROMOTION BEFORE THE MARKETING AUTHORISATION (MA) IN ITALY – CENTRALIZED REGISTRATIONS
If a medicinal product is not yet authorized in Italy, it is not possible to do promotional activities except for…
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RETURN TO INTERNATIONAL GMP INSPECTIONS BY MHRA
Since March 2020, MHRA Inspectorate has not conducted on-site inspections unless they were linked to the UK Government’s COVID-19 response…
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ADVANCED THERAPY MEDICINAL PRODUCT (ATMP) CLASSIFICATION
The European Medicines Agency (EMA) gives companies the opportunity to request the ATMP classification with the aim to confirm whether…
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EMA DRAFTS RECOMMENDATIONS ON IDENTIFYING SUITABLE RWD SOURCES FOR STUDIES
Real world data (RWD) describe the experience of patients through data collected in surveys, registries, and more recently from sensors…
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EVALUATION OF A CLINICAL TRIAL APPLICATION IN ITALY ACCORDING TO REGULATION (EU) NO. 536/2014
According to the Regulation (EU) no. 536/2014, the evaluation of a clinical trial application in CTIS includes three main steps:…
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USABILITY ASSESSMENT OF MEDICAL DEVICES AND IN VITRO DIAGNOSTIC DEVICES
The Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR) require the demonstration of compliance with the General Safety and Performance Requirements (GSPRs)…
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TRANSPARENCY IN HEALTHCARE: SUNSHINE ACT
The Sunshine Act (Law 62 of May 31st, 2022 published in the Italian Official Journal on June 11th, 2022), concerns…
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MEDICAL DEVICE CLASSIFICATION – FOCUS ON SUBSTANCE BASED MEDICAL DEVICE
The Regulation (EU) 745/2017 requires stricter classification rules for substance-based medical devices together with timely pharmaco-toxicological evaluation of components. Classification Rule…
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SOUTH AFRICA: MARKETING AUTHORIZATION RENEWAL’S GUIDELINE IMPLEMENTATION
The size of the South Africa’s pharmaceutical market has a value of more than $4 billion (2021 data). A substantial…
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