ADVANCED THERAPY MEDICINAL PRODUCT (ATMP) CLASSIFICATION

The European Medicines Agency (EMA) gives companies the opportunity to request the ATMP classification with the aim to confirm whether…

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EMA DRAFTS RECOMMENDATIONS ON IDENTIFYING SUITABLE RWD SOURCES FOR STUDIES

Real world data (RWD) describe the experience of patients through data collected in surveys, registries, and more recently from sensors…

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CLINICAL TRIALS – EVALUATION OF A CLINICAL TRIAL APPLICATION IN ITALY ACCORDING TO REGULATION (EU) NO. 536/2014

According to the Regulation (EU) no. 536/2014, the evaluation of a clinical trial application in CTIS includes three main steps:…

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USABILITY ASSESSMENT OF MEDICAL DEVICES AND IN VITRO DIAGNOSTIC DEVICES

The Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR) require the demonstration of compliance with the General Safety and Performance Requirements (GSPRs)…

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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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