The EMA has collated its biosimilars advice into one document to tell firms when to expect a GMP inspection and other events.
In the document the European Medicines Agency (EMA) answers 43 questions about the process for approving biosimilars. Several of these cover biosimilar GMPs (good manufacturing practice) and inspection requirements in Europe.
“The level of GMP supervision and the GMP standards applied to similar biological medicinal products are the same as for any other medicinal product”, the EMA wrote in its biosimilars advice document .
As with other centralised applications, developers of biosimilars face EMA inspections to verify GMP compliance or to check specific manufacturing and control activities linked to assessment of a filing.
The EMA does GMP compliance inspections when a facility, normally located outside the European Economic Area (EEA), has gone more than three years without a regulatory visit. In cases when this visit is needed the EMA wants an early warning inspection request to avoid unnecessary delays.
Early warning of assessment-related inspections is harder as until the report is available the EMA is unable to decide if a visit is needed. To compensate the EMA fast-tracks the process and usually does the inspection within three months of the request.
Fees for inspections of biosimilars production plants are the same as for other products. At the start of April the EMA increased the charge to €20,100 (€26,400) in line with inflation of three per cent.