Within the scope of the recent digital transformation initiatives led by the Brazilian Health Regulatory Agency (Anvisa), the issuance workflow for the Letter of Adequacy of the Active Pharmaceutical Ingredient Dossier (CADIFA) has undergone a significant update. The final stage of this service has migrated to a new internal system, resulting in a document with a renewed visual identity and automated data-filling processes. 

Although these changes are strictly administrative and visual—without creating new regulatory or operational impacts for holders — they reflect a continuous search for agility and the reduction of manual errors in API (Active Pharmaceutical Ingredient) management. This workflow optimization, however, is merely the most recent chapter in a trajectory that has profoundly altered how Brazil controls the quality of active substances. 

To understand the scope of this digital simplification, it is essential to revisit the pillars sustaining CADIFA and the normative path that established this instrument in the country.

CADIFA: rigor and Compliance 

Established by Collegiate Board Resolution (RDC) No. 359/2020, CADIFA is the official document certifying that an Active Pharmaceutical Ingredient (API) is in full compliance with the Agency’s technical requirements. Unlike previous mechanisms, the Letter focuses on the adequacy of the Active Pharmaceutical Ingredient Dossier (DIFA), ensuring that the quality, safety, and efficacy of the substance have been meticulously evaluated. 

Currently, this document is mandatory for the registration and post-registration of synthetic and semi-synthetic medicinal products, covering categories ranging from new medicinal products to generics (unbranded) and similar products (branded generics). Its importance lies in guaranteeing that the active principle—whether imported or manufactured domestically—strictly complies with the specifications required for the Brazilian market. 

History: from Individual control to international harmonization 

The evolution of CADIFA in Brazil is marked by a transition from an “individual registration” model to an “adequacy of dossier” system, bringing Anvisa closer to international standards, such as those of the European EDQM. 

1. The Pre-2020 Scenario: until then, API control was primarily governed by RDC No. 57/2009. The focus was on the registration of the ingredient, often directly linked to the registration of the finished medicinal product. This model generated duplicate technical analyses and lacked the agility required by global market updates. 

1. The 2020 Framework: the implementation of RDCs No. 359, 361, and 362 in August 2020 shifted the paradigm. The creation of CADIFA introduced the concept of “shared use”, allowing a single document to be utilized by multiple medicinal product manufacturers, thereby optimizing the product lifecycle and regulatory management. 

1. Consolidation and Efficiency (2021-2026): following a transition period that ended in 2021, CADIFA became the mandatory pathway. Evolution continued with the publication of procedural manuals and, more recently, the implementation of Regulatory Reliance strategies, allowing Anvisa to leverage technical assessments from equivalent foreign authorities to accelerate issuance in Brazil. 

Digital Transition

The implementation of the new CADIFA model in 2026, with its new visual identity and the signature repositioned at the end of the document (following Annex 1), crowns this maturation process. By automating information, the Agency not only gains celerity but also reinforces the transparency and standardization necessary for a predictable regulatory environment. 

For the regulated sector, the continuity of the application procedures via the Solicita system and the maintenance of the required technical content ensure that ongoing projects proceed under a more modern internal workflow. 

Recent procedural updates from Anvisa reflect a commitment to public service innovation and administrative efficiency. Monitoring this evolution requires attention to technical details and the maintenance of dossier compliance. For further information on how these workflows apply to your business model, our team of specialists is available for consultation.