"Participating in this scheme might be the decisive factor between keeping EU development in concert with your development in other countries or not.
As an example, EMA does not always concur with what FDA require.
Consequently, seeking advice from both agencies becomes crucial in order to ensure that your development strategies in both regions are discussed and agreed upon.
This optimises the potential of your product for approval or investment purposes."
https://www.transcrip-group.com/resources/the-importance-of-sme-status-and-how-it-can-help-unlock-success-in-eu-medicine-development/
"Especially, fee reductions can be significant incentives for SMEs. For example: for a multidisciplinary EMA scientific advice procedure, SMEs pay a fee of around 8,000 euros instead of 80,000 euros for non-SMEs. To benefit from any fee incentives, the SME status has to be assigned by EMA’s SME Office before a regulatory submission. Therefore, it is recommended to consider registration as an SME early during the development."
https://www.mf-biotech.com/insights/ema-small-businesses-sme-incentives
Ann: PharmAust Granted SME Status by European Medicines Agency, page-6
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