Observational studies: From the November 30, 2021 Decree to the new document of the National Coordination Center for Ethics Committees
Pharmacological observational studies concern drugs prescribed according to an authorized therapeutic indication and based on normal clinical practice.
Clinical trials Regulation: AIFA endorsed a proposal for the temporary administration of trials pursuant to the CTR, pending the publication and full implementation of the ministerial decrees on the reorganization of ethics committees and single tariff
The Consolidated Act on Rare Diseases is finally approved
After three years, Italy has finally adopted its first law on rare diseases. On November 3, 2021, the Italian Senate unanimously approved the Consolidated Act on Rare Diseases, or “Testo Unico sulle malattie rare”.
Artificial Intelligence and Machine Learning in Clinical Trials: Regulatory attempts by European and national authorities
In the last few years, use of Artificial Intelligence and Machine Learning systems in the performance of Clinical Trials has increased.
Italian Competition Authority investigates orphan drug manufacturer (Leadiant) for excessive pricing
In October 2019, the Italian Competition Authority launched an investigation into abuse of dominance pursuant to Article 102 TFEU against the Leadiant group in connection with the marketing in Italy of the “orphan” drug Chenodeoxycholic Acid Leadiant, used to treat an ultra-rare disease.
Online sales of counterfeit medicines: AIFA recommendations and actions to combat the issue
On April 9, 2021, the Italian Medicines Agency, or Agenzia Italiana del Farmaco (the “AIFA” or the “Agency”) published a Nota informativa notice containing details regarding risks stemming from online purchases of medicines.