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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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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