Anvisa's API Registration Coordination (COIFA), releases this week the SERVICE GUIDANCE Nº 58/COIFA/DIRE2/ANVISA, whih Provides for the analysis of petitions related to the registration of active pharmaceutical Ingredients and to the dossiers of active pharmaceutical Ingredients submitted in drug products processes under Decree nº 8.077, of 2013, Law nº 9.784, of 1999, of Resolution RDC nº 204, of 2005, and the Resolution RDC nº 57, of 2009.
It is important to share this information not only with drug manufacturers, but also with API manufacturers, who will henceforth have an increasingly active and important role in maintaining the regular status of their products in the Brazilian market.
See the original Portuguese Anvisa version here.
