# 90-day reliance approval for cancer drugs cleared by two stringent regulators

Source: https://onco.cc/ideas/idea-reg-reliance-90-day-lmic/  
OnCo record `idea-reg-reliance-90-day-lmic` (Idea). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Summary

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.

## Fields

- Kind: Idea
- Last checked: 2026-09-08
- Hypothesis: Countries adopting the 90-day reliance pathway cut the median registration lag for new oncology medicines from more than two years to under one year, with no excess of safety signals relative to the originating regions.
- Rationale: The scientific review has been done; the delay is administrative. Reliance is already how most vaccines reach LMICs through WHO prequalification, and the East African Community joint assessment has shown that pooled reliance shortens registration by years.
- Proposed test: Work with five countries (for example Kenya, Ghana, Nigeria, Peru and the Philippines) to adopt the pathway for oncology and measure registration lag against the WHO essential medicines list oncology section before and after.
- Maturity: early-clinical
- Actor: regulator

## Sources

- WHO Good Reliance Practices (page moved; nearest live section): https://www.who.int/publications/i/item/

## Connected records

- bottlenecks: [Most of the world has almost no cancer care](https://onco.cc/bottlenecks/b-global-access/), [Regulatory divergence between regions](https://onco.cc/bottlenecks/b-regulatory-fragmentation/)
- roadmaps: [Global access and affordability roadmap: essential medicines and generics → biosimilars and frugal trials → reliance, pooling and homegrown innovation](https://onco.cc/roadmaps/global-access-roadmap/)

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