The European Medicines Agency (EMA) granted the qualification of “Small and Medium-Sized Enterprises” (SME) to Microviable Therapeutics.
The European Medicines Agency (EMA) provides incentives and support for micro, small and medium-sized enterprises (SMEs) that are developing medicines for human or veterinary use, in order to promote innovation and the development of new medicines.
The incentives offered by the SME Regulation apply to the human and veterinary sectors, and include:
Regulatory assistance, scientific advice and other incentives include: fee incentives, organisation of info days and training sessions for SMEs, regulatory updates, assistance with translations, information required for the granting of an EU marketing authorisation, inclusion in the public SME register, guidance on clinical data publication, etc.
