They revised checklists for post-approval minor variations (MIV-1 and MIV-2) with:
- Re-categorisation from MIV-2 Notification to MIV-2 Do-And-Tell (for Drug Substance, Drug Product, and Excipients)
- New checklists under MIV-2 Do-And-Tell and MIV-1
- Other changes, such as extending the scope of the product labelling change under Do-And-Tell, for example.
They extended the audit assessment pathway to biologics, including biosimilars.
And finally, they added other updates on biosimilar product applications, minor/ editorial amendments to appendices, and editorial updates to guidance documents.
