On November 23rd, the Active Pharmaceutical Ingredients Registration Coordination (COIFA) of Anvisa held a Workshop to discuss the DIFA/CADIFA topic and the regulations related to Active Pharmaceutical Ingredients (RDC 359/20, RDC 361/20, and RDC 654/22).
Among the discussions brought up during the event, COIFA reiterated the objective of CADIFA, which corresponds to Centralized Analysis (greater harmonization of technical analysis), Single submission of DIFA, Single standard for the regulation of all APIs, International harmonization (internalization of ICH Guides and EDQM model); Direct communication with DIFA holders.
Several topics were addressed, but we would like to highlight in this post the numbers presented regarding the associated CADIFA requests already analyzed by the Agency.
So far, the Agency has concluded the analysis of 155 associated CADIFA requests, with 89 approved, 15 rejected, and 51 ended due to withdrawal of the request. The numbers indicate that only 57.4% of associated CADIFA requests with completed analysis were approved by the Agency.
Regarding rejected requests, the Agency pointed out the main reasons for rejection, as follows:
▪ Manual Protocol and CTD format not followed;
▪ Absence of Module 1 (administrative documents – Application Form and Annexes);
▪ Absence of Restricted Part (Module 3);
▪ Documents not related to CADIFA Application;
▪ Additional issues: Documents not organized.
*Data from COIFA’s presentation – CADIFA 2023 Seminar.
The data show that, although the regulations have been in force for three years, some API manufacturers have encountered difficulties complying with the standard.
Also, ANVISA informed that COIFA is working in a Q&A document to solve the main questions received by the regulatory agency regarding CADIFA application. Stay tuned, as soon as ANVISA publish the Q&A, we from TM RA Consultancy will share it with our partners.
