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.<\/p>\n
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.<\/p>\n
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.<\/p>\n
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).<\/p>\n
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.<\/p>\n