ASMF: NEWS ON ASMF SUBMISSION REQUIREMENTS IN ITALY
AIFA has recently published the updated procedures to be followed for the initial submission of an Active Substance Master File…
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SALES REPRESENTATIVES: REGIONAL REQUIREMENTS FOR PROMOTION TO HCPS
In accordance with Legislative Decree 219/2006, medical sales representatives are the only professional profiles that are allowed to promote medicinal…
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STEPWISE PIP: EMA SUPPORT FOR THE AUTHORISATION OF INNOVATIVE MEDICINES
The Paediatric Investigation Plan (PIP), introduced by Regulation (EC) No 1901/2006, is a research and development programme aimed at ensuring…
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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…
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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…
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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…
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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…
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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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