Snapshot

The Optimized Analysis Procedure (NORMATIVE INSTRUCTION - IN NO. 289, OF MARCH 20, 2024) pathway has been developed by the of Brazil.

This pathway can be used where medicines, vaccines, biological products and their active pharmaceutical ingredients.

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

When relevant, the agency relies on prior decisions from Australia Canada EU-EMA Switzerland United Kingdom United States WHO

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