EMA Waives GMP Inspection Fees During COVID-19

The European Medicines Agency (EMA) is waiving fees for on-site GMP inspections of drug makers and blood establishments that have undergone remote inspections during COVID-19.

Plasma Master Files inspections are also in the scope of this initiative and will follow the same principle, if applicable.

The 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 was enacted on May 12, 2020 and will remain effective during the COVID-19 pandemic where access to sites for inspections were restricted as a result of the virus.

During the initiative, any request for inspection covered by this decision will be assigned the applicable reduced fee. No separate request for fee reduction by the applicant or Marketing Authorization Holder is required during this period.

Source: European Medicines Agency

Leave a Reply

Your email address will not be published. Required fields are marked *