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Project Orbis is a scheme where the FDA and partner regulators (Australia, Canada, UK, Switzerland, Singapore, Brazil, Israel) review a cancer drug at the same time.
Project Orbis is a scheme under which the FDA and partner regulators in Australia, Canada, the UK, Switzerland, Singapore, Brazil and Israel review a cancer drug application at the same time. It began in 2019, and concurrent submission and review has shortened the gap between US approval and approval in partner countries from years to months for many oncology drugs. It is not a joint decision: each regulator reaches its own verdict independently. The term is referenced by the related terms BLA / NDA / MAA (marketing applications) and PDUFA dates and Regulators beyond the FDA (EMA/CHMP, MHRA, PMDA, NMPA, TGA), and it appears in the global access and affordability roadmap and the trial modernisation roadmap as one of the mechanisms that move approvals across borders.
Shares ILAP (Innovative Licensing and Access Pathway), BLA / NDA / MAA (marketing applications) and PDUFA dates, Regulation (EC) No 726/2004: the EU centralised procedure.
Shares Medicines and Medical Devices Act 2021, ICH good clinical practice (E6), Regulation (EC) No 726/2004: the EU centralised procedure.
Shares BLA / NDA / MAA (marketing applications) and PDUFA dates, Regulators beyond the FDA (EMA/CHMP, MHRA, PMDA, NMPA, TGA).
Shares BLA / NDA / MAA (marketing applications) and PDUFA dates, Regulators beyond the FDA (EMA/CHMP, MHRA, PMDA, NMPA, TGA).
Shares ILAP (Innovative Licensing and Access Pathway), Regulation (EC) No 726/2004: the EU centralised procedure.
Shares Trial modernisation roadmap: the randomised trial → platforms and adaptive designs → decentralised, pragmatic and always-on, Global access and affordability roadmap: essential medicines and generics → biosimilars and frugal trials → reliance, pooling and homegrown innovation.
Shares ICH good clinical practice (E6), Regulators beyond the FDA (EMA/CHMP, MHRA, PMDA, NMPA, TGA).
Shares ICH good clinical practice (E6), Regulators beyond the FDA (EMA/CHMP, MHRA, PMDA, NMPA, TGA).