SOUTH AFRICA: MARKETING AUTHORIZATION RENEWAL’S GUIDELINE IMPLEMENTATION
The size of the South Africa’s pharmaceutical market has a value of more than $4 billion (2021 data). A substantial…
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PHARMACOVIGILANCE IN ITALY – THE NEW NATIONAL PHARMACOVIGILANCE NETWORK
The National Pharmacovigilance Network (RNF), that is the system by which reports of suspected adverse drug reactions (ADRs) are collected,…
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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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