Anvisa (National Health Surveillance Agency) has published two consultation panels on the Active Pharmaceutical Ingredient Dossier Adequacy Letter (Cadifa). This tool allows users to check and follow up on documents issued, as well as consult the analysis queue for these records.
The first panel was developed to consult the issuance of the Cadifa, allowing users to check the valid version of the letter, or whether it has been suspended or canceled. Information such as the Cadifa holder, the active pharmaceutical ingredient (API), the letter number, the date of the last review and the validity status of the review is displayed. The information is in line with the practices of international authorities that use similar regulatory models for the sanitary control of APIs.
The second panel, relating to Cadifa notifications linked to post-registration, offers the possibility of consulting the distribution order for examining these letters, especially in the context of petitions related to post-registration. The search can be carried out in various ways, including by file number, regulatory category, post-registration status and the file number of the notification.
These panels reflect Anvisa’s commitment to transparency in the process of analyzing drug registrations, in accordance with the Access to Information Law (Law 12.527/2011).
Cadifa is an administrative instrument that certifies that the Active Pharmaceutical Ingredient Dossier (Difa) complies with Collegiate Board Resolution (RDC) 359/2020, and is part of the revision of the regulatory framework for APIs used in new, innovative, generic and similar medicines.
At ELS Group, we believe that the availability of the Cadifa panels by Anvisa is an important milestone for the pharmaceutical sector, as it improves transparency and modernizes the monitoring of regulatory processes. These tools make it possible to quickly check the status of the Cadifa, such as validity, revision and history, as well as monitoring the order of analysis of post-registration petitions, which facilitates strategic planning and reduces uncertainty for companies.
For companies working with active pharmaceutical ingredients or medicines, understanding these changes is essential to ensuring regulatory compliance and optimizing registration and post-registration processes. With the right support, you can navigate these new tools efficiently, speed up product regularization and minimize regulatory risks.
If you need more information on regulatory issues, ELS can certainly help.
ontact your local ELS consultant or via email info@elssolutions.pt
