Pre-submission Advice & Support for Innovative Medicines
Key Changes
- MHRA offers a pre-submission service for innovative medicines.
- Service is described as available before applying for medicines Marketing Authorisations.
- Service is described in relation to clinical variations for innovative medicines.
Affected Roles
Teams developing innovative medicinesProspective Marketing Authorisation applicants
Action Required
Review suggestion only - original source must be reviewed before compliance decisions; consider reviewing the MHRA guidance to assess whether pre-submission advice may be relevant to planned submissions.