CALL FOR COMPANIES TO REGISTER THEIR INDUSTRY SINGLE POINT OF CONTACT (I-SPOC) ON SUPPLY AND AVAILABILITY
As laid down in Regulation (EU) 2022/123, the European Medicines Agency (EMA) has a primary role in monitoring and mitigating…
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MEDICAL DEVICES – REGULATION (EU) 2017/745
Slightly more than a year after the Regulation 2017/745 (MDR) came into force, many medical device manufacturers are still struggling…
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PHARMACEUTICAL COMPANIES RELATIONSHIP WITH EXPERT PATIENTS – FARMINDUSTRIA REGULATIONS
Pharmaceutical companies frequently cooperate with patient associations by involving their representatives as speakers in events and meetings. Relationships between pharmaceutical…
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CLINICAL EVALUATION OF MEDICAL DEVICE SOFTWARE
The Regulation 2017/745 (MDR) requires that the demonstration of compliance with the General Safety and Performance Requirements for the medical…
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EUDAMED – REGISTRATION OF LEGACY DEVICES
“Legacy devices” are medical devices, covered by a valid Medical Device Directive certificate (Declaration of Conformity for class I medical…
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DIGITAL APPLICATION DATASET INTEGRATION (DADI) NETWORK PROJECT
The Digital Application Dataset Integration (DADI) is a Network Project led by the EMA to transform and optimise regulatory procedure…
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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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