On June 15, 2026, Normative Instruction (IN) No. 451/2026 was published in the Diário Oficial da União — DOU, amending IN No. 292/2024, which sets out the criteria and procedures for defining Equivalent Foreign Regulatory Authorities (EFRAs) in the sanitary inspection process and establishes the optimized analysis procedure for Good Manufacturing Practice (GMP) certification purposes for manufacturers of active pharmaceutical ingredients (APIs), Cannabis based products, medicines, and biological products.

The main amendments to IN 292/2024 seek to provide greater procedural clarity and expand ANVISA’s scope in managing international partnerships. A brief overview of the most impactful changes is set out below.

Changes in EFRA Management (Articles 4 and 5):

• Designation/Exclusion of EFRAs: ANVISA’s Collegiate Board of Directors (DICOL) now explicitly deliberates on the designation and/or exclusion of authorities listed in the Annex to IN 292/2024, based on the opinion of the relevant technical areas (Art. 4, caput).
• Decentralized Entities: it is established that, when an EFRA is listed in the Annex to IN, its decentralized authorities or entities are also recognized for optimized analysis purposes. The detailed list of these entities will be made publicly available on the ANVISA Portal (Art. 4, §§2 and 3).
• Review and Revocation of EFRA Designations: DICOL has the authority to review or revoke, at any time, the designation of any authority as an EFRA, regardless of the level of recognition previously established (Art. 4, §5).

Enhancement of the Optimized Procedure (Article 11):

• Optional nature of the Optimized Analysis Procedure: the regulation now explicitly states that the optimized analysis procedure is optional and must follow the terms of RDC No. 497/2021, which governs the administrative procedures for the granting of GMP Certification and Good Distribution and/or Storage Practice Certification (Art. 11, §1).
• Submission workflow: documentation issued by the EFRA must now be filed under a specific amendment subject code within each GMP certification process (Art. 11, §2). In addition, the manufacturer may optionally submit documents classified as confidential directly to ANVISA within 30 days of filing the certification petition (Art. 11, §§3 and 4).

Annex Updates:

• Segregation of EFRA lists: the list of authorities has been divided into two annexes. Annex I lists authorities with partial or full reliance levels, while Annex II is intended for authorities with Mutual Recognition status. NOTE: it should be noted that, as of the publication of IN 451/2026, no EFRAs with mutual recognition status have been listed. 
• Inclusion of Jordan: the Jordan Food & Drug Administration (JFDA) is now listed as item 26 in Annex I as an equivalent authority.
• Periodic Updates: the regulation states that the Annexes will be updated in accordance with the regulatory workflow and the procedures for periodic update subject codes, thereby enabling a more expeditious review.

Subject Codes for Filing:

In view of the amendment to IN 292/2024, ANVISA has made available new subject codes to be used when filing amendments to certification processes for classification under the Optimized Analysis Procedure, as applicable:

• 70960 – Pharmaceutical Ingredients (Optimized Procedure – EFRA Report for GMP Certification purposes)
• 70961 – Biological Active Pharmaceutical Ingredients (Optimized Procedure – EFRA Report for GMP Certification purposes)
• 70962 – Medicines (Optimized Procedure – EFRA Report for GMP Certification purposes)
• 70963 – Biological Products (Optimized Procedure – EFRA Report for GMP Certification purposes)

The subject codes previously used for requesting GMP certification through the optimized analysis route will be discontinued. Processes filed prior to the publication of IN 451/2026 will be automatically migrated to the new analysis procedure, without any prejudice to companies.

Practical Impacts:

The new wording promotes process integration by aligning the filing procedure for the optimized analysis route with the ordinary certification workflow, reducing operational complexity for the industry. The recognition of decentralized entities provides legal certainty for manufacturers operating in jurisdictions with regionalized inspection systems.

For the regulatory sector, the amendments optimize resource allocation and increase transparency in the governance of international partnerships. Maintaining ANVISA’s inspection authority for routine audits, combined with the expansion of the list of equivalent authorities, supports a reduction in certification lead times and accelerates access to medicines, active pharmaceutical ingredients (APIs), and Cannabis based products in the Brazilian market.