ADVERTISING OF OTC/SOP MEDICINAL PRODUCTS FOR GENERAL PUBLIC ON SOCIAL MEDIA

The responsible Authority for the evaluation of the advertising concerning OTC/SOP medicinal products on social medial in Italy is the…

READ

MDCG 2022 – 5 GUIDANCE ON BORDERLINE BETWEEN MEDICAL DEVICES AND MEDICINAL PRODUCTS UNDER REGULATION (EU) 2017/745 ON MEDICAL DEVICES

The Medical Device Coordination Group (MDCG) recently published the Guidance on borderline between medical devices and medicinal products under Regulation…

READ

RULES AND PROCEDURES TO ACCESS THE AIFA NATIONAL FUND FOR ORPHAN DRUGS

Law 326/2003 provided for the establishment of a national fund at AIFA for the use of “orphan drugs and for…

READ

PHARMACOECONOMIC AND BUDGET IMPACT ANALYSES SUBMITTED TO AIFA – REPORT 2021

In accordance with the new AIFA Guidelines entered into force on 30 December 2020, the Applicant has to submit pharmacoeconomic…

READ

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…

READ

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…

READ

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…

READ

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…

READ

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…

READ

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…

READ