Snapshot

The Optimized Analysis Procedure pathway has been developed by the of Brazil.

This pathway can be used where APIs, medicinal products and biological products.

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

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

The modalities of the optimized analysis procedure for the purposes of regularization of medicinal products, APIs, and biological products and their active substances are: I – Modality A: applicable to the petition for regularization of a medicinal product, API, or biological product submitted to assessment by Anvisa, which has been previously approved by an EFRA for a maximum of 1 (one) year. II – Modality B: applicable to the petition for regularization of a medicinal product, API, or biological product submitted to Anvisa, which has been previously approved by an EFRA for over 1 (one) year, or that has been qualified for analysis in modality B in Annex II or III of Anvisa's Normative Instruction (Reference 1). III – Modality C: applicable to a medicinal product defined as of lower risk, in accordance with the guidelines provided for in a specific guide published by Anvisa. The analysis of the application for regularization of medicinal products and biological products shall be completed in up to 150 calendar days from the date the regularization application was submitted. The analysis of post-regularization applications, regardless of the modality applied for the marketing authorization, shall be completed in up to 90 days.