ANVISA: Updated Version of the CADIFA Manual available

The new version of the "CADIFA Manual for Administrative Procedures" of the Brazilian Health Regulatory Agency (Anvisa) was published in February 2025 and is available on its website in Portuguese and English language.

The manual has been valid since August 2020 and needs to be followed for API dossiers. The Active Pharmaceutical Ingredient dossier (DIFA) must be submitted to the agency by the DIFA holder to receive a CADIFA (letter of suitability of the active pharmaceutical ingredient). It shows the compliance of a DIFA with the regulatory requirements. Both a valid CADIFA and a GMP certificate are necessary for the approval of an associated marketing authorization or post-approval change application.

In the very beginning the manual was structured into six main chapters with several subchapters, including a document history as well as a list of abbreviations. Now, in addition to the document history and the list of abbreviations, the manual contains eight main chapters with several subchapters, which are listed below:

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

The document history clearly mentions that most of the updates and changes made in the new version of the manual are part of the chapters "I. Introduction", "III. Before submission" and "VI. Solicita procedures". As an example for chapter VI., the sub-section "11. Change of CADIFA applicant submission" was added.

All changes and updates made in the new version of the "CADIFA Manual for Administrative Procedures" are listed in detail in the document history. You can find the "CADIFA Manual for Administrative Procedures, MANUAL-F-ANVISA-011 v.01" on the website of Anvisa.