THE AIFA’S INNOVATIVENESS APPRAISAL FOR MEDICINES
A standardized procedure to evaluate the innovativeness of medicines has been implemented by the Italian Medicines Agency since 2017 (AIFA…
READ
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…
READ
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…
READ
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…
READ
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…
READ
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…
READ
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:…
READ
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)…
READ
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…
READ
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…
READ