CHINESE NPMA ANNOUNCEMENT ON IMPLEMENTING THE APPLICATION WITH ELECTRONIC COMMON TECHNICAL DOCUMENTS
As of 29 December 2021, the marketing authorization of chemicals with Registration Categories 1 and 5.1, therapeutic biological products with…
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MINISTERIAL DECREE OF NOVEMBER 30TH, 2021 CONCERNING NO-PROFIT CLINICAL TRIALS OF MEDICINES AND OBSERVATIONAL STUDIES
As of March 6th, 2022, with the entry into force of the Ministerial Decree of November 30th, 2021, concerning the…
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THE NEW EUROPEAN PORTAL FOR CLINICAL TRIAL SUBMISSION (CLINICAL TRIAL INFORMATION SYSTEM – CTIS)
As of 31st January, 2022, the Clinical Trials Information System (CTIS) has gone live and thus the Clinical Trials Regulation…
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EMA PRIME SCHEME: 5 YEAR REVIEW (2015-2021)
On 3rd March 2022 the European Medicines Agency (EMA) released the 5-years report for its PRIME (PRIority MEdicines) scheme, that…
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NEW AIFA P&R E-DOSSIER PLATFORM – STATE OF THE ART
Following the provisions of the Ministerial Decree of 2 August 2019 “Criteria and methods by which the Italian Medicines Agency…
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MEDICAL DEVICE CLASSIFICATION – FOCUS ON MEDICAL DEVICE SOFTWARE (MDSW)
The Regulation 2017/745 (MDR) introduced several news for software classified as Medical Devices (Medical Device Software, MDSW).Classification Rule 11 and…
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ADVERTISING OF MEDICAL DEVICES FOR GENERAL PUBLIC
The Competent Authority for the evaluation of the advertising concerning medical devices in Italy is the Ministry of Health (MoH)….
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CLINICAL TRIALS – TRANSITIONAL OPERATING PROCEDURE FOR CLINICAL TRIALS IN ITALY ACCORDING TO REGULATION (EU) NO. 536/2014
With the activation of the CTIS on January 31st 2022, Clinical Trials Regulation (EU) no. 536/2014 has officially entered into…
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SCIENTIFIC ADVICE ON MEDICINE REPURPOSING
The European Medicines Agency (EMA) and National Competent Authorities (NCA) are working on a pilot project to offer scientific advice…
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THE EPI PROJECT
In March 2017, the European Commission (EC) published its report on current shortcomings in the summary of product characteristics (SmPC)…
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