Minor process changes introduced
We will be introducing two minor process changes in January 2020.
Paediatric licence extensions:
From January 2020, abbreviated submissions for paediatric licence extensions will no longer be requested. We will update ADTCs when paediatric licence extensions are granted and highlight advice for the corresponding indication in adults, however no SMC advice statement will be issued.
ADTCs may make formulary decisions on paediatric licence extensions for medicines that were previously accepted for use (or restricted use) in adults.
Fast-track resubmission process:
From January 2020, resubmissions made within three months of the original SMC decision may proceed via a fast-track process if the only change is a new or improved Patient Access Scheme (PAS). This will allow the resubmission to proceed directly to the SMC committee with an overall assessment timeline of up to 14 weeks.