Regulatory Changes

Pharmaceutical companies wishing to participate in the pilot must submit the same documentation to all involved national authorities, thus standardizing the submission process.

Regulatory Intelligence teams must monitor updates regarding the ongoing CHMP evaluation and potential implications for existing marketing authorizations.

Stakeholders should assess the proposed changes to the fee structure and provide feedback by September 25, 2026. This includes understanding the implications of the new fee levels and service standards on their compliance efforts.