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Brazil Catches Up With International Standards on Viral Safety Evaluations For Biotech Products

 
• By Francesca Bruce

The Brazilian medicines regulator will also offer more clarity on the requirements for radiopharmaceuticals that are exempt from registration.

Brazil updates guidance on radiopharmaceuticals and viral safety evaluations for biotech products (Shutterstock)
Key Takeaways
  • The Brazilian medicines regulator is developing guidance that will bring national requirements on standards for viral safety evaluations of biotechnology into line with ICH standards.
  • The regulator will also introduce more clarity on the requirements for radiopharmaceuticals that are exempt from registration through new guidance.
  • Both sets of guidance are out for consultation until September 2025.

Companies can soon expect that Brazilian requirements on standards for viral safety evaluations of biotechnology products will be brought into line with standards published by the International Conference On Harmonisation...

Separately, the country’s drug regulator, ANVISA, is also planning to remedy the current “lack of clear guidelines” and uncertainty for companies with respect to requirements for radiopharmaceuticals that are exempt...

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