THE NEW HTA REGULATION: WHAT IMPLICATIONS FOR PHARMACEUTICAL COMPANIES?

The Regulation (EU) 2021/2282 of the European Parliament and the Council of the European Union on health technology assessment became…

READ

REORGANIZATION OF THE ETHICS COMMITTEES IN ITALY

The four decrees on the reorganization of the Ethics Committees, which are a further step towards the full implementation in…

READ

THE REGULATION (EU) NO. 536/2014 IS NOW MANDATORY FOR NEW CLINICAL TRIAL APPLICATIONS

Starting from January 31st, 2023 the new clinical trial applications have to be submitted only through the Clinical Trial Information…

READ

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