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EU: EMA waives certain GMP inspection fees during COVID-19

2020/05/18  RAPS

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.”

The decision comes after EMA and other EU authorities released guidelines explaining their regulatory expectations amid the pandemic that allowed for distant assessments by national competent authorities.

EMA says that marketing authorization holders will automatically have the fee waived for qualifying inspections and that no separate fee waiver request is necessary.

National competent authorities conducting the distant assessments will be fully remunerated, “If the national competent authority provides a comprehensive inspection report for the distant assessment and a subsequent independent report for the in-site inspection.”

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