90-day reliance approval for cancer drugs cleared by two stringent regulators
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.
- Regulatory divergence between regions · Regulatory divergence means a drug approved in one country can take years to reach another, or never arrive.
- Most of the world has almost no cancer care · Seven in ten cancer deaths happen in low- and middle-income countries, where radiotherapy, pathology, surgery and drugs are scarce.
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not linked directly; found by shared links- IdeaFund an oncology joint assessment unit inside the African Medicines Agency
Shares Regulatory divergence between regions, Most of the world has almost no cancer care.
- IdeaLive tracker of the lag from first approval to real availability in every country
Shares Regulatory divergence between regions, Most of the world has almost no cancer care.
- IdeaWHO prequalification plus pooled demand to push biosimilar prices below 10% of the originator
Shares Regulatory divergence between regions, Most of the world has almost no cancer care.
- InstitutionComisión Federal para la Protección contra Riesgos Sanitarios
Shares Regulatory divergence between regions, Most of the world has almost no cancer care.
- IdeaReciprocal recognition of tumour-agnostic and rare-indication approvals across regulators
Shares Regulatory divergence between regions, Most of the world has almost no cancer care.
- ProductTrastuzumab biosimilars
Shares Regulatory divergence between regions, Most of the world has almost no cancer care.
- IdeaGet the one approved appetite drug licensed beyond a single country
Shares Regulatory divergence between regions, Most of the world has almost no cancer care.
- TermBiosimilar
Shares Regulatory divergence between regions, Most of the world has almost no cancer care.