Singapore HSA Updated the Guidance on Therapeutic Product Registration

Medication tablets
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.
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