TRANSPARENCY IN HEALTHCARE: SUNSHINE ACT

The Sunshine Act (Law 62 of May 31st, 2022 published in the Italian Official Journal on June 11th, 2022), concerns…

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MEDICAL DEVICE CLASSIFICATION – FOCUS ON SUBSTANCE BASED MEDICAL DEVICE

The Regulation (EU) 745/2017 requires stricter classification rules for substance-based medical devices together with timely pharmaco-toxicological evaluation of components. Classification Rule…

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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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