Disclosure of grounds of European withdrawn and refused applications: a step forward on regulatory transparency


  • The opinions expressed in this article are the personal views of the authors and may not be understood or quoted as being made on behalf of or reflecting the position of the Italian Medicines Agency or the Dutch Medicines Evaluation Board.


Dr Francesco Trotta PhD, Pharmacovigilance Unit, Italian Medicines Agency (AIFA), Via del Tritone, 181, Rome 00187, Italy.

Tel.: +39 (0) 6 5978 4363

Fax: +39 (0) 6 5978 4142.

E-mail: f.trotta@aifa.gov.it

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