Manufacturers can compress years of national review into weeks or days by asking weaker regulators to 'rely' on prior approvals (FDA, EMA, WHO prequalification) rather than repeating the full assessment. That shortcut accelerates patient access in low‑capacity countries but shifts risk‑allocation (post‑market surveillance, local population-specific evaluation) from pre‑market review to downstream systems.
— This reframes global access debates: faster approvals are administratively feasible today, but they raise questions about regulatory sovereignty, corporate influence, and who bears post‑approval safety monitoring.
2026.09.22
100% relevant
Zambia Medicines Regulatory Authority approved Gilead’s lenacapavir for HIV prevention in 12 days using reliance on prior high‑income regulator decisions and trial evidence.
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