The guide for applicants and Marketing Authorization Holders (MAH) involved in GMP and GCP inspections coordinated by the EMA as well as the IRIS guide have been updated.Good Manufacturing Practices (GMP) are the principles and gu

This new guideline, currently under public consultation, defines the elements of the pregnancy prevention programme and specifies when such a programme or other risk minimisation measures are necessary to prevent the adverse conse

Every year, the European Medicines Agency (EMA) adjusts its fees on 1 April, in line with the European Union (EU) inflation rate for the previous year.On 1 April 2018 general, non-pharmacovigilance fees payable to E