DIGITALIZATION OF THE P&R APPLICATION TO AIFA: THE E-DOSSIER
According to the AIFA Determination n. 1372 of 30 December 2020, companies that intend to negotiate the price for pharmaceuticals…
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5 YEARS EXPERIENCE WITH PRIME – EMA REPORT
Similar to FDA’s Breakthrough Therapy designation, through the PRIME (PRIorityMEdicines) scheme, the European Agency (EMA) offers early and proactive support to medicine developers…
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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…
READSUNSET 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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