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  • Feature ArticlesFeature Articles

    Italy Reimbursement Profile

    This profile summarizes the reimbursement process in Italy, presents key stakeholders and highlights what should be considered early in the development process. Obtaining regulatory approval for medicines is the first major hurdle of most pharmaceutical and biotechnology companies looking to launch their products worldwide. However, obtaining market access once products are approved by regulatory agencies (e.g., AIFA) is a separate and crucial process without which pat...
  • Regulatory NewsRegulatory News

    Italian Medicines Agency Cites Brazilian Drugmaker for GMP Violations

    The Italian Medicines Agency (AIFA) has banned the supply of certain drugs made by Antibioticos do Brasil (ABL) following an inspection of the company's San Paulo, Brazil facility in December. In total, AIFA cites the company for four critical and seven major deficiencies, including inadequate maintenance and cleaning; poor levels of training and awareness of good manufacturing practices (GMP); and insufficient environmental monitoring. As a result of the findings, AIFA...
  • European Regulatory Roundup: Italy Fines Aspen $5.7M for Increasing Cancer Drug Prices by 1,500% (20 October 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Norwegian Government-Funded Study Supports Switching Patients to Remicade Biosimilar A trial funded by the Norwegian government has generated data to support switching from Johnson & Johnson’s Remicade to a biosimilar. Overall, participants with rheumatoid arthritis, Crohn’s disease and other conditions who switched to the biosimilar had comparable outcomes to patients ...
  • Regulatory NewsRegulatory News

    Italian Medicines Agency Finds Major Deficiencies at Radiopharmaceutical Manufacturer

    The Italian Medicines Agency (AIFA) released a non-compliance report on Wednesday for the Rome-based radiopharmaceutical manufacturer Iason Italia with deficiencies linked to quality issues. AIFA says that based on its inspection from 8 October, Iason does not comply with good manufacturing practice (GMP) requirements. This is the third GMP non-compliance report posted to one part of EudraGMDP – the European database of pharmaceutical manufacturing violations -- in rece...
  • Italian Regulators Call for Clinical Data to be Disaggregated by Gender

    • 05 February 2013
    The Italian national regulatory agency, AIFA, has called upon pharmaceutical companies to include gender-disaggregated data in the submission of regulatory documents, including marketing approval applications, so as to highlight any differences. The agency explained that preclinical and clinical research provided by the pharmaceutical industry to regulatory agencies often does not show efficacy and safety data by gender.  AIFA noted that analysis of the female po...
  • Italian, Swiss, Spanish Regulators Ban Sale of Novartis Flu Vaccines

    • 26 October 2012
    Two influenza vaccines manufactured by Novartis, a Swiss pharmaceutical company, have seen their marketing privileges temporarily revoked in at least three European countries this week as regulators expressed concerns regarding contamination and possible adverse side effects. The vaccines-Agrippal and Flaud-were first banned by the Italian Health Ministry after the Italian Pharmaceutical Agency (AIFA) said it was aware of the, "Presence of a protein aggregation phenome...