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…
READ
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…
READ
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…
READ
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,…
READ
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…
READ
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…
READ
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…
READ
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…
READ
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…
READ
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…
READ
