ideasIdea
Every regulator publishes its full assessment report so others can rely on it
Europe already publishes a detailed report explaining why each drug was approved. If every country did, smaller regulators could reuse the work.
EMA's European Public Assessment Reports and FDA's review packages are public; most other regulators publish little. Reliance pathways depend on access to assessment reports, which are currently exchanged bilaterally under confidentiality agreements, if at all. The proposal is an ICH-level commitment that every member publishes a structured assessment report within 60 days of decision, with a standard redaction protocol for commercially confidential information, and deposits it in a shared index.
Hypothesis
Countries with access to indexed assessment reports register new oncology medicines faster and with fewer requests for additional data than countries without, and the number of formal reliance decisions rises year on year.
Rationale
Reliance cannot scale on bilateral trust; it needs a public evidence base. Publication also exposes divergence, which itself drives convergence.
What would test it
Build the shared index with the reports already public (EMA, FDA, Health Canada, TGA, Swissmedic) and track its use by LMIC regulators; then negotiate publication commitments from PMDA, NMPA, ANVISA and CDSCO.
Maturity
early clinical
Who has to act
regulator
Cost to try
Small (under $1M)
Years to first evidence
2
Bottlenecks it attacks
- Regulatory divergence between regions · Regulatory divergence means a drug approved in one country can take years to reach another, or never arrive.
- Knowledge reaches practice too slowly · Knowledge diffusion is slow: it takes years for a proven result to change what most patients receive, and no one can keep up with the literature.