ANVISA Updates CADIFA Manual: Key Changes for API Regulations

 The Brazilian Health Regulatory Agency (ANVISA) has released version 01 of the CADIFA Manual for Administrative Procedures (MANUAL-F-ANVISA-01), introducing significant updates to streamline the assessment and management of Active Pharmaceutical Ingredient (API) dossiers. These changes aim to improve ANVISA API regulatory changes, reduce redundancy, and facilitate smoother API registration and API dossier submission in Brazil.

Why is This Update Important?

APIs form the backbone of pharmaceutical manufacturing, and their regulatory compliance directly impacts drug safety, efficacy, and availability. The ANVISA Manual updates address key industry challenges by:

  • Enhancing regulatory predictability for API manufacturers.
  • Facilitating faster market entry for compliant APIs, benefiting pharmaceutical companies and patients.
  • Aligning with international standards, making Brazil’s regulatory framework more robust and globally recognized.
  • Reducing duplication of efforts, enabling manufacturers to leverage previously approved API documentation efficiently.

Key Highlights in the ANVISA CADIFA Manual update

The ANVISA updated CADIFA process introduces several important changes aimed at enhancing regulatory processes through technological advancements and streamlined procedures. These updates are crucial for stakeholders in the pharmaceutical industry to ensure compliance and benefit from improved efficiency.

1. Requirement for DIFA Holders

DIFA holders are now required to submit updated registry information via a specific form. This change enhances record accuracy and accelerates processing times – a vital step in meeting CADIFA requirements for APIs.

2. Similar DIFA

  • Purpose: Allows DIFA holders to apply for an additional CADIFA for the same API when changes cannot be accommodated within the existing CADIFA.
  • Scenarios: Applicable in cases of alternative manufacturing processes, different sites, or varying API grades.

3. Use of CADIFA by Another CADIFA

  • Purpose: Enables a secondary CADIFA application to reference a primary CADIFA for its starting material or intermediate.
  • Benefit: Reduces redundancy by leveraging validated information from an existing CADIFA, aligning with regulatory changes for APIs Brazil.

4. New Application Procedures

The manual introduces the ability to request additional information or corrections post-submission. This change allows for greater flexibility and responsiveness during the review process.

5. Optimized Analysis Procedures

  • Normative Instruction (IN) No. 289/2024: This process applies when the API’s quality matches that approved by an Equivalent Foreign Regulatory Authority (AREE).
  • Advantage: Facilitates faster approvals for APIs recognized by trusted global regulatory agencies.

6. Change of CADIFA Holder

  • Applicability: Covers corporate transactions like spin-offs, mergers, or acquisitions that change CADIFA ownership.
  • Condition: Ensures that the API’s technical and sanitary characteristics remain unchanged during the transfer.

7. Electronic Format and Simplified Processing

The manual emphasizes the mandatory use of electronic means for submission and processing, aligning with modern technological standards. Additionally, a new chapter on simplified processing has been incorporated, outlining the required formalities to streamline procedures.

8. Updated Forms and Checklists

To support compliance and structured submissions, ANVISA has introduced new regulatory forms, including:

  • Application Form (FORM-635. MANUAL-F-ANVISA-011)
  • Registry Form (FORM-634. MANUAL-F-ANVISA-011)
  • Checklist (Annex III of IN 289/2022)
  • Form for Change of CADIFA Holder

Understanding ANVISA’s changing regulations is essential for pharmaceutical companies registering APIs and drug products in Brazil. Freyr, a trusted regulatory partner, provides expert guidance with Brazil API regulations 2025 and a smooth market entry. Contact us today to simplify your regulatory submissions in Brazil and stay up-to-date with ANVISA updates!

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