Europe – EMA waives certain GMP inspection fees during COVID-19

The European Medicines Agency (EMA) this week announced it is waiving fees for on-site good manufacturing practice (GMP) inspections of drugmakers and blood establishments that have undergone remote inspections during the coronavirus disease (COVID-19) pandemic under certain circumstances.

Specifically, EMA says it will fully waive fees for sites that undergo remote inspections where GMP compliance cannot be confirmed and the inspection must be rescheduled “due to the limitations of a distant assessment.” The policy entered into force on 12 May and will remain in place “during the period where access to sites for inspections were restricted due to COVID-19.”…