# Latest

**URL:** https://fusionpharma.discourse.group/latest.md

[Latest](https://fusionpharma.discourse.group/latest.md) · [Categories](https://fusionpharma.discourse.group/categories.md) · [Tags](https://fusionpharma.discourse.group/tags.md)

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## [Welcome to Fusion Pharma Limited!](https://fusionpharma.discourse.group/t/welcome-to-fusion-pharma-limited/5)

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**Author:** [@system](https://fusionpharma.discourse.group/u/system)\
**Replies:** 0\
**Last updated:** [27 July 2026 10:43 UTC](https://fusionpharma.discourse.group/t/welcome-to-fusion-pharma-limited/5 "2026-07-27T10:43:12Z")

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We are so glad you joined us. Here are some things you can do to get started: Introduce yourself by adding your picture and information about yourself and your interests to your profile. What is one thing you’d like to…

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## [MHRA Product Information Quality Unit (PIQU) webinar 21/10/2026](https://fusionpharma.discourse.group/t/mhra-product-information-quality-unit-piqu-webinar-21-10-2026/147)

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**Author:** [@Aidan\_Fusion](https://fusionpharma.discourse.group/u/Aidan_Fusion)\
**Replies:** 0\
**Last updated:** [22 October 2026 08:41 UTC](https://fusionpharma.discourse.group/t/mhra-product-information-quality-unit-piqu-webinar-21-10-2026/147 "2026-10-22T08:41:16Z")

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On 21 October, the MHRA ran a webinar to discuss recent changes to labelling guidance. This webinar then also covered some worked examples of mock-ups that were both ready for approval and those that would be rejected in…

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## [Test post - is this medicine OK to licence?](https://fusionpharma.discourse.group/t/test-post-is-this-medicine-ok-to-licence/145)

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**Author:** [@AidanR3](https://fusionpharma.discourse.group/u/AidanR3)\
**Replies:** 0\
**Last updated:** [19 October 2026 12:31 UTC](https://fusionpharma.discourse.group/t/test-post-is-this-medicine-ok-to-licence/145 "2026-10-19T12:31:18Z")

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Test postTest postTest postTest postTe :grinning\_face: st post

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## [What should a submission-readiness review cover before a new MAA is filed?](https://fusionpharma.discourse.group/t/what-should-a-submission-readiness-review-cover-before-a-new-maa-is-filed/141)

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**Author:** [@NewUser](https://fusionpharma.discourse.group/u/NewUser)\
**Replies:** 1\
**Last updated:** [19 October 2026 12:28 UTC](https://fusionpharma.discourse.group/t/what-should-a-submission-readiness-review-cover-before-a-new-maa-is-filed/141 "2026-10-19T12:28:02Z")

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This has come up while planning the next regulatory step, and it may affect both timing and the evidence package. What should a submission-readiness review cover before a new MAA is filed? What would you confirm before f…

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## [Does Project Orbis replace the need for a country-specific regulatory strategy?](https://fusionpharma.discourse.group/t/does-project-orbis-replace-the-need-for-a-country-specific-regulatory-strategy/144)

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**Author:** [@NewUser](https://fusionpharma.discourse.group/u/NewUser)\
**Replies:** 0\
**Last updated:** [14 October 2026 14:11 UTC](https://fusionpharma.discourse.group/t/does-project-orbis-replace-the-need-for-a-country-specific-regulatory-strategy/144 "2026-10-14T14:11:32Z")

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I am interested in how others would structure the assessment before a decision is taken. Does Project Orbis replace the need for a country-specific regulatory strategy? Which checks make the greatest difference to a robu…

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## [When should we start preparing a marketing authorisation renewal?](https://fusionpharma.discourse.group/t/when-should-we-start-preparing-a-marketing-authorisation-renewal/143)

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**Author:** [@NewUser](https://fusionpharma.discourse.group/u/NewUser)\
**Replies:** 0\
**Last updated:** [14 October 2026 14:08 UTC](https://fusionpharma.discourse.group/t/when-should-we-start-preparing-a-marketing-authorisation-renewal/143 "2026-10-14T14:08:41Z")

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When should we start preparing a marketing authorisation renewal? How would you distinguish the core requirement from points that depend on the individual product?

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## [How early should we decide between a UK national MAA and another available route?](https://fusionpharma.discourse.group/t/how-early-should-we-decide-between-a-uk-national-maa-and-another-available-route/135)

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**Author:** [@NewUser](https://fusionpharma.discourse.group/u/NewUser)\
**Replies:** 0\
**Last updated:** [9 October 2026 12:41 UTC](https://fusionpharma.discourse.group/t/how-early-should-we-decide-between-a-uk-national-maa-and-another-available-route/135 "2026-10-09T12:41:13Z")

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We are reviewing our approach and would welcome views from colleagues who have handled this in practice. How early should we decide between a UK national MAA and another available route? Which facts would you establish f…