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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.
Shares Knowledge reaches practice too slowly, Regulatory divergence between regions.
Shares Knowledge reaches practice too slowly, Regulatory divergence between regions.
Shares Knowledge reaches practice too slowly, Regulatory divergence between regions.