Anvisa Releases Harmonized Guidelines on Drugs, Biologicals

Brazil’s Anvisa has released guidelines on biological controls, drug manufacturing and clinical trials to harmonize with international standards.

The three guidelines are the first in a number Anvisa is expected to release in coming weeks, says Roberto Rodrigues, an attorney with Licks Advogados in Rio de Janeiro.

Qualifications for Transporting Biological Products explains the requirements for validating temperature-control procedures during shipping. It marks the first time Anvisa has addressed specific issues for biological products, Rodrigues says.

The other two guidelines — Outcomes for Clinical Studies of Cancer Drugs and Summary of Process Validation for Drug Manufacturing — are based, in part, on documents from the FDA and European Medicines Agency.

Aside from the temperature control requirements for biologicals, the guidelines, while new in Brazil, largely formalize what have been ongoing Anvisa policies, Rodrigues said. All three took effect Oct. 9, but comments may be submitted through April 6.

Read Outcomes for Clinical Studies of Cancer Drugs at www.fdanews.com/10-15-Anvisa-Guide1.pdf, Summary of Process Validation for Drug Manufacturing at www.fdanews.com/10-15-Anvisa-Guide2.pdf and Qualifications for Transporting Biological Products at www.fdanews.com/10-15-Anvisa-Guide3.pdf. — Jonathon Shacat