EMA: aggiornamento Q&A pre-authorization Guidance per farmaci orfani

EMA ha rilasciato una nuova versione delle linee guida relative alle Q&A in fase pre-autorizzativa per i farmaci orfani, le tempistiche di valutazioni ed ispezioni. Qui di seguito sono riportati i quesiti aggiornati:

• 3.2.2 What aspects should I consider if my medicinal product has been designated as an orphan medicinal product at the time of submission of my application?
• 3.2.4 What aspects should I consider at time of submission of my application for marketing authorisation if there are orphan medicinal products designated or authorised for a condition related to my proposed therapeutic indication?
• 3.2.5 What aspects should I consider if my medicinal product is considered similar to an orphan medicinal product?
• 5.1.1 How long does it take for my application to be evaluated?
• 5.1.11 Can EMA assessment or inspection documents be shared with third parties?
• 5.2.1 When can I expect a pre-authorisation GMP inspection and how are the conducted?
• 5.2.2 When can I expect a pre-approval GCP inspection and how are they conducted?

La versione completa è disponibile qui: https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/pre-authorisation-guidance