Check the updated version of the Cadifa Manual of Administrative Procedures.

Anvisa has just published the third version of the Cadifa Manual on administrative procedures. The document was updated due to the migration of the petition of matters related to Cadifa (Adequacy Letter of Active Pharmaceutical Input Dossier) to the Solicita System, following the implementation of the new regulatory framework for active pharmaceutical inputs (IFAs).

This is another change contemplated by Anvisa’s digital transformation, which aims to standardize procedures and allow the monitoring of petitions filed with the Agency. In this way, after the migration, we will no longer have requests for matters related to Cadifa through the manual protocol, or through the petition system.

In the updated version of the manual, the petition with manual protocol was excluded and information on regulatory user, comparative table, visualization of files submitted via the Solicita System and storage of incomplete submissions were added. The companies will be able to follow the messages, referring to the fulfillment of requirements and resources also through Solicita.

It is important to point out that Solicita System allows you to upload numerous files of up to 25MB simultaneously. And there are a range of file types that are allowed (jpg, jpeg, bmp, png, pdf, doc, docx, xls, and xlsx) making it easy to upload. After sending a file, the user can view it on the system itself.

What is the Cadifa Manual?

The Active Pharmaceutical Input Dossier (Difa) and CadifaA were established by Collegiate Board Resolution (RDC, in Portuguese) 359/2020, entering into force on August 3, 2020. This RDC provides for the sending of Difa by its holder to Anvisa. This has changed the previous dynamics of registration and post-registration of new, innovative, generic and similar drugs in Brazil. These new rules allow foreign companies to directly carry out the procedures for issuing Cadifa, with no need of intermediaries, becoming a regulatory framework.

In order to facilitate and speed up this process, Anvisa prepared the Cadifa Manual, which provides guidance to Difa holders, such as, for instance, registering the company, receiving documents sent by the Agency and submitting Difa and its changes.

In addition to RDC 359/2020, we also have RDC 361/2020, which provides for the need for Cadifa and the Certification of Good Manufacturing Practices (CBPF, in Portuguese) for the registration and post-registration of medicines. This new standard also updates the presentation and life cycle management of documents related to active pharmaceutical inputs, establishing a transition period for the registration and post-registration of medicines, in accordance with the new regulatory framework.

How does direct sending work?

The new way of sending documents directly by the Difa holder is a common practice in other markets, but it is still a challenge for Anvisa. This is the first time that a company, without a CNPJ (company registration number in Brazil), is allowed to directly file a petition for document approval and issuance the Cadifa through Anvisa’s systems. When we look at it, it’s a trend that other regulatory agencies have, such as the American and European ones that have a similar mechanism.