CADIFA Manual for Administrative Procedures – MANUAL-F-ANVISA-011 v.01

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CADIFA Manual for Administrative Procedures:

The updated CADIFA Manual for Administrative Procedures by ANVISA was published in February 2025 and is available in Portuguese and English on the agency’s website.

CADIFA Manual for Administrative Procedures – MANUAL-F-ANVISA-011 v.01
CADIFA Manual for Administrative Procedures – MANUAL-F-ANVISA-011 v.01

First introduced in August 2020, this manual outlines the requirements for “Active Pharmaceutical Ingredient” (API) dossiers. The DIFA holder must submit an API dossier (DIFA) to obtain a CADIFA (Letter of Suitability), confirming regulatory compliance. Both a valid CADIFA and a GMP certificate are required for marketing authorization or post-approval changes. Initially, the manual had six main chapters, but it has now been expanded to eight main chapters, along with a document history and a list of abbreviations, are make a list below:

    1. INTRODUCTION
    2. SCOPE
    3. BEFORE SUBMISSION
      1. REGISTRY
      2. APPLICATION TYPE
        • Initial Application
        • Change Application
        • Deficiency Letter Response
        • Other Applications
      3. ORGANIZATION OF DIFA
        • Module 1: Administrative Information
        • Module 2: Quality Overall Summary
        • Module 3: Quality
      4. SIMILAR DIFA
      5. USE OF CADIFA BY ANOTHER CADIFA
      6. Optimized analysis procedure
      7. CHANGE OF CADIFA HOLDER
    4. SUBMISSION OF APPLICATION
      • INITIAL SUBMISSION
      • SUBSEQUENT SUBMISSIONS
      • DEFICIENCY LETTER RESPONSE SUBMISSION
      • MAILBOX
    5. AFTER SUBMISSION
      • APPROVAL
      • DEFICIENCY LETTER
      • REJECTION
      • CLOSURE
    6. SOLICITA PROCEDURES
      • HOW TO ACCESS SOLICITA
      • INITIAL APPLICATION SUBMISSION
      • CHANGE AND OTHER APPLICATIONS
      • HOW TO CONTINUE A SAVED SUBMISSION
      • PRINTING SUBMISSION RECEIPT
      • VIEWING SUBMITTED DOCUMENTS
      • DEFICIENCY LETTER RESPONSE SUBMISSION
      • ACCESSING SOLICITA MAILBOX AND READING MESSAGE
      • APPLICATION STATUS CONSULTING
      • MONITORING APPLICATION STATUS
      • CHANGE OF CADIFA APPLICANT SUBMISSION
    7. REFERENCES
    8. RELATED FORMS

The updated modifications and apprises managed in the newfound translation of the “CADIFA Manual for Administrative Procedures MANUAL-F-ANVISA-011 v.01” are available in the document narration.

Masuu offers expert support in navigating the updated CADIFA Manual for Administrative Procedures. We guide clients through API dossier preparation, ensuring compliance with ANVISA’s requirements for obtaining a CADIFA (Letter of Suitability) and GMP certification. Our services cover initial applications, deficiency letter responses, and post-approval changes. With in-depth knowledge of the manual’s expanded structure, we streamline your submission process, ensuring all regulatory steps are met. Whether accessing SolicitA or managing subsequent submissions, Masuu ensures efficient, compliant, and timely processing for your applications.

Reference: https://www.gov.br/anvisa/pt-br/centraisdeconteudo/publicacoes/medicamentos/publicacoes-de-insumos-farmaceuticos/manual-cadifa.pdf
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