# Every regulator publishes its full assessment report so others can rely on it

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

## TL;DR

Europe already publishes a detailed report explaining why each drug was approved. If every country did, smaller regulators could reuse the work.

## Summary

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.

## Fields

- Kind: Idea
- Last checked: 2026-09-08
- 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.
- Proposed test: 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
- Actor: regulator

## Sources

- EMA medicines and EPARs: https://www.ema.europa.eu/en/medicines

## Connected records

- bottlenecks: [Knowledge reaches practice too slowly](https://onco.cc/bottlenecks/b-knowledge-diffusion/), [Regulatory divergence between regions](https://onco.cc/bottlenecks/b-regulatory-fragmentation/)

---
JSON: https://onco.cc/api/v1/entities/idea-reg-public-assessment-reports-all.json