Regulatory update, AIFA essential documents

November 2015 – The Italian Medicines Agency (AIFA) has released a list of essential documents that the Applicant must submit with the original dossier when applying for a Marketing Authorization for a bioequivalence (BE), or bioavailability trial.

The whole document is available on the Agency web site.

English version

Italian version

The document clarifies a previous version of the requirements, released in May 2014, also upon discussion with the GCP working group of GIQAR, (Italian Group of Quality Assurance in Research) in which CROss Alliance™ Quality Assurance Manager was directly involved.

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