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Switzerland Swissmedic's Guide to Project Orbis, Orphan Drug Framework, and Packaging Requirements
Bringing innovative medicines to patients requires more than scientific excellence. Pharmaceutical companies must navigate complex regulatory pathways, demonstrate product quality, ensure appropriate labeling, and comply with country-specific requirements before a medicinal product reaches the market. Swissmedic, Switzerland's national authority for therapeutic products, has established several regulatory mechanisms that facilitate patient access to innovative therapies while
Sharan Murugan
Jun 144 min read
UK MHRA Project Orbis: Accelerating Global Access to Innovative Cancer Medicines Through International Regulatory Collaboration
The global regulatory landscape for oncology medicines is increasingly moving toward collaborative review models that enable faster patient access to innovative treatments. One of the most significant initiatives in this area is Project Orbis, a multinational programme that allows concurrent submission and review of promising cancer medicines across several international regulatory authorities. The UK Medicines and Healthcare products Regulatory Agency (MHRA) guidance on Proj
Sharan Murugan
May 313 min read
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...
Sharan Murugan
Mar 13, 20221 min read
First authorisation under Project Orbis - UK MHRA
Project Orbis is an innovative programme coordinated by the US Food and Drug Administration (FDA) with Canada, Australia, Switzerland,...
Sharan Murugan
May 10, 20211 min read