Brazil Pursues Regulatory Reliance Strategy For GMP Inspections

 
• By Francesca Bruce
  
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Brazil has listed 42 international regulatory bodies as equivalent authorities, including US FDA and the EU’s EMA.

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Brazil lists 42 equivalent regulatory authorities in regulatory reliance drive • Source: Shutterstock

Brazil’s medicines regulator, ANVISA, has published new rules setting out procedures for using good manufacturing practice (GMP) inspections and certification processes carried out by foreign authorities deemed to be equivalent regulatory bodies. The move is part of a drive by ANVISA to exploit regulatory reliance as a means of ensuring high-quality medicines get to Brazilian patients.

The regulator published Regulation IN 292/204 in the official Gazette on 3 May. It sets out optimized procedures for analyzing...

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