TGA Approach to Predetermined Change Control Plans

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Closes 5 Jun 2026

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1. Did the guidance clearly explain how PCCPs work across different regulatory pathways?
(Required)
2. Did the guidance clearly explain what a PCCP can and cannot cover?
(Required)
3. Did the guidance clearly explain the relationship between PCCPs and variations, for example when a variation would be needed if a PCCP has been approved?
(Required)
4. Are there any material issues or content gaps in the guidance?
(Required)
5. Was the language and terminology appropriate and easy to understand?
(Required)
6. Do you have any suggestions for improvement?