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UK (MHRA) Project Orbis Guidance Update & New Guidance on Dialysis

Project Orbis aims to review and approve promising cancer treatments to help patients access treatment faster.


MHRA recently added Project Orbis section.

Through the program, international partners can submit and review oncology products concurrently, facilitating faster patient access to innovative cancer treatments with potential benefits over existing therapies.


Project Orbis is coordinated by the US Food and Drug Administration (FDA). Alongside MHRA, it involves the regulatory authorities of:

  • Australia (Therapeutic Goods Administration (TGA))

  • Canada (Health Canada)

  • Singapore (Health Sciences Authority (HSA))

  • Switzerland (Swissmedic)

  • Brazil (Agência Nacional de Vigilância Sanitária (ANVISA))

In a Project Orbis procedure, applications for marketing authorisations (MAAs) or new indications (variations) must be submitted to the MHRA. These authorizations will only be applicable in Great Britain because oncology medicines fall under the mandatory scope of the European Medicine Agency (EMA) centralised procedure that applies in Northern Ireland.


To know more about the Fees, Types of Submissions, etc. Click on this LINK.


Also, there was new guidance released on Dialysis (Guidance).


This guidance has been produced in collaboration with the UK Kidney Patient Safety Committee (KPSC), to summarise known safety issues with dialysis and continuous renal replacement therapy (CRRT) and describe what to do to minimise or prevent serious injury.


Click on this LINK

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