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Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

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John HoneypotCEO9999999999999
Jane TrapdataCFO-8888888888

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Optimized analysis using an equivalent foreign authority

Brazil · Brazilian Health Regulatory Agency · New drugs

Reliance route, abridged reviewFaster routeHigh confidenceLast verified October 3, 2026

Review target

Not published

Legal time limit

Not published

Steps

5 requirements

What is the Optimized analysis using an equivalent foreign authority in Brazil?

For medicines, vaccines, biologics and active ingredient letters already approved by at least one equivalent foreign authority, Anvisa can use that authority's assessment and run a verified review instead of a full one. Items specific to Brazil still get an ordinary review, and Anvisa decides on its own. Registration and post-approval changes of products approved by an equivalent foreign authority, when the product filed in Brazil has the same essential characteristics.

What are the steps of the Optimized analysis using an equivalent foreign authority?

1. File the full dossier; 2. Reliance addendum; 3. Eligibility check; 4. Verified or abbreviated review; 5. Decision by Anvisa.

Does the Optimized analysis using an equivalent foreign authority rely on other regulators?

Yes. It relies on approvals from Australia, Canada, Switzerland, European Union, United Kingdom, Japan, United States, World Health Organization programs (verification, verification, verification, verification, verification, verification, verification, verification).

Outcome: Registration decided by Anvisa with a verified or abbreviated analysis.

Legal basis: Anvisa RDC 741/2022; Anvisa IN 289/2024; Anvisa RDC 948/2024 (Art. 42)

How the pathway works

Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).

ApplicantRegulatorCertification bodyCommitteeClock stopped

Timeline with clock stops

Official step durations

Steps

In order, with the official target for each step

1. File the full dossierThe full dossier required for the product category is still filed.
2. Reliance addendumA specific addendum with the comparison forms, the foreign authority's assessment documents and proof that the foreign approval is current.
3. Eligibility checkThe technical area checks whether the request qualifies.
4. Verified or abbreviated reviewA verified review when nothing differs from the foreign approval; an abbreviated review of the critical points when something differs. Brazil-specific items get an ordinary review.
5. Decision by AnvisaThe decision is Anvisa's alone and is not bound by the foreign decision.

Requirements

What the applicant must provide or meet

Reference approval

Approved by at least one equivalent foreign authorityThe product must be approved and currently registered by the chosen reference authority. The company chooses the reference authority and must report any restrictive foreign decision at once.

Eligibility

Same essential characteristicsEssential characteristics must be identical to those approved abroad, including quality. Differences must be justified.

Other

Complete foreign assessment documentsThe foreign assessment documents must be complete and not redacted for relevant information.
Brazil-specific items reviewed normallyDocuments specific to the national context, such as population, epidemiology and local quality parameters, go through the ordinary review.

After approval

Post-approval changes within 18 months(in some cases)Changes approved by the foreign authority can use this route if filed within 18 months of the foreign approval.

Fee	Amount
No fees published.

Reliance on other regulators

AustraliaVerificationTGA. The product must be registered by the reference authority and have identical essential characteristics, including quality.
CanadaVerificationHealth Canada. The product must be registered by the reference authority and have identical essential characteristics, including quality.
SwitzerlandVerificationSwissmedic. The product must be registered by the reference authority and have identical essential characteristics, including quality.
European UnionVerificationEuropean Medicines Agency, centralized procedures. The product must be registered by the reference authority and have identical essential characteristics, including quality.
United KingdomVerificationMHRA. The product must be registered by the reference authority and have identical essential characteristics, including quality.
JapanVerificationPMDA, limited to product quality information. The product must be registered by the reference authority and have identical essential characteristics, including quality.
United StatesVerificationUS FDA. The product must be registered by the reference authority and have identical essential characteristics, including quality.
World Health Organization programsVerificationWorld Health Organization. The product must be registered by the reference authority and have identical essential characteristics, including quality.

Rule changes

Reliance route for medicines adds an abbreviated analysisAdopted, May 7, 2026

Optimized analysis using an equivalent foreign authority

What is the Optimized analysis using an equivalent foreign authority in Brazil?

What are the steps of the Optimized analysis using an equivalent foreign authority?

Does the Optimized analysis using an equivalent foreign authority rely on other regulators?

How the pathway works

Timeline with clock stops

Steps

Requirements

Reference approval

Eligibility

Other

After approval

Official time targets

Fees

Reliance on other regulators

Rule changes