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If the FDA and EMA have both approved a cancer drug, a smaller country should be able to approve it in three months using their reports rather than starting over.
WHO's Good Reliance Practices and the WHO-Listed Authority framework already permit national regulators to rely on the assessments of stringent agencies. The proposal is a statutory 90-day abridged pathway in low- and middle-income countries for oncology medicines approved by at least two WHO-listed authorities, with the national review limited to labelling, local supply and pharmacovigilance arrangements. Swissmedic's MAGHP and the EU-M4all procedure are partial precedents.
Shares Regulatory divergence between regions, Most of the world has almost no cancer care.
Shares Global access and affordability roadmap: essential medicines and generics → biosimilars and frugal trials → reliance, pooling and homegrown innovation, Regulatory divergence between regions, Most of the world has almost no cancer care.
Shares Global access and affordability roadmap: essential medicines and generics → biosimilars and frugal trials → reliance, pooling and homegrown innovation, Most of the world has almost no cancer care.
Shares Global access and affordability roadmap: essential medicines and generics → biosimilars and frugal trials → reliance, pooling and homegrown innovation, Regulatory divergence between regions.
Shares Global access and affordability roadmap: essential medicines and generics → biosimilars and frugal trials → reliance, pooling and homegrown innovation, Most of the world has almost no cancer care.
Shares Global access and affordability roadmap: essential medicines and generics → biosimilars and frugal trials → reliance, pooling and homegrown innovation, Most of the world has almost no cancer care.
Shares Regulatory divergence between regions, Most of the world has almost no cancer care.
Shares Global access and affordability roadmap: essential medicines and generics → biosimilars and frugal trials → reliance, pooling and homegrown innovation, Most of the world has almost no cancer care.