EMA to waive certain GMP inspection fees during COVID-19 pandemic

The European Medicines Agency (EMA) has announced it will waive fees for on-site good manufacturing practice (GMP) inspections of drug developers and blood establishments that have undergone remote inspections during pandemic, under certain circumstances.

This policy is in alignment with guidelines previously released by EMA and other EU authorities explaining their regulatory expectations amid the pandemic that allow for distant assessments by national competent authorities (NCA).

Fees will be fully waived 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.”

NCAs undertaking the distant assessments will be fully remunerated if they provide a comprehensive inspection report and a subsequent independent report for the on-site inspection at an appropriate time.

The policy also notes that marketing authorisation holders will automatically have the fee waived for qualifying inspections and a separate fee waiver request will not be necessary.

The policy commenced on 12 May and will continue to remain as long as access to sites for inspections is restricted due to COVID-19.

Find out more here.