PUBLICATION OF THE UPDATED AGREEMENT TEMPLATE BY THE NATIONAL COORDINATION CENTER OF ETHICS COMMITTEES FOR CLINICAL TRIALS ON MEDICINES FOR HUMAN USE AND ON MEDICAL DEVICES

The National Coordination Center of Ethics Committees for clinical trials on medicines for human use and on medical devices has…

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SUNSET CLAUSE IN ITALY: CURRENT REGULATION AND EXEMPTION REQUEST

According to the Legislative Decree 219/2006 (art.38), any Marketing Authorisation of National/MRP/DCP medicinal products ceases to be valid: In case…

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PERSON RESPONSIBLE FOR REGULATORY COMPLIANCE FOR MEDICAL DEVICES

The presence of at least a Person Responsible for Regulatory Compliance (PRRC) is one of the new regulatory obligations introduced…

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RARE DISEASES AND ORPHAN DRUGS IN ITALY

On 27th November 2021, a new piece of legislation on rare diseases was published in the Italian Official Journal (Law…

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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…

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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…

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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…

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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…

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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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