Prescription medicines collection

If an ingredient name is not on the approved list, you can submit a proposal for it to be included

Guidance for sponsors and applicants preparing applications and requests involving steps in the manufacture of medicines regulated as prescription medicines

Electronic data interchange for ICSR submission using the E2B R2 format

Guidance on colourings in medicines for topical and oral use

Checklist to assist in a priority review designation application

This is a step-by-step guide for agents and sponsors who wish to apply for Priority review, Provisional determination or Orphan drug designation of a prescription medicine.

Pre-submission meeting forms

The NeeS specification is an interim arrangement as applicants plan the move to full eCTD

Update to the six clinical evaluation streams and the functions each unit provides