,Regulation: ANVISA Redefines Petition Codes for Package Inserts, Labels, and Names of Biological and Radiopharmaceutical Products
The redefinition of petition codes related to package inserts, labeling, and names of biological and radiopharmaceutical products by ANVISA, including changes in the petition process and alignment with federal government principles.
ANVISA | Pharmaceuticals | Regulatory AffairsCOFEPRIS Presents the Drug Health Registration Viewer
New digital platform providing real-time information on the validity and legality of medicines in Mexico, replacing the previous consultation mechanism.
COFEPRIS | Pharmaceuticals | Regulatory AffairsANVISA Manual for Importation by DUIMP (Version 1.7)
Guidelines for importers on the process of petitioning the Single Import Declaration (DUIMP) through the Single Foreign Trade Portal, including registration, electronic signatures, and sanitary control procedures.
ANVISA | Pharmaceuticals | Regulatory AffairsANVISA's Board of Directors Expands List of Radiopharmaceutical Drugs
ANVISA's Board of Directors discussed and approved updates on regulations for radiopharmaceutical drugs during their 5th Public Meeting of 2026.
ANVISA | Pharmaceuticals | Regulatory AffairsMFDS Establishes Expedited Review Regulations for Biosimilars in South Korea
South Korea’s MFDS introduces expedited review regulations for biosimilars, reducing approval timelines and enhancing flexibility in managing manufacturing changes to support the biopharmaceutical sector.
MFDS | Pharmaceuticals | Regulatory Affairs
Consult
