ANVISA: Version 2 of the CADIFA Manual for APIs available

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17/18 September 2024

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The new version of the "CADIFA Manual for Administrative Procedures" of the Brazilian Health Regulatory Agency (Anvisa) was published in June 2021 and is available on its website in Portuguese and in English language.

Since August 2020, the manual has been valid 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 general, the manual is structured in six main chapters and twelve annexes, including a document history as well as a list of abbreviations. The main chapters are named as listed below:

• I INTRODUCTION 
• II SCOPE
• III BEFORE SUBMISSION
• IV SUBMISSION SYSTEMS
• V AFTER SUBMISSION
• VI REFERENCES

The chapters "III Before Submission", "IV Submission Systems" and "V After Submission" contain of further sub-sections, describing the procedures and processes of the Brazilian submission requirements in detail.

The document history clearly mentions that most of the updates and changes made in the new version of the manual are part of chapter "III Before Submission". As an example for this chapter, the sub-sections "2. Application Type" and "4. Organization of DIFA" were updated in several sub-passages, now contain new figures and have new templates.

All changes and updates made in the new version of the CADIFA manual are listed in detail in the document history. Here you can find the "CADIFA Manual for Administrative Procedures, CADIFA Manual nº 01, 2nd Version" on the website of Anvisa.