1. Pink Sheet

Brazil To Use Regulatory Reliance For GMP Inspections

 
• By Francesca Bruce

Brazil’s medicines regulator Anvisa is considering new rules that would define regulatory reliance procedures for inspections and good manufacturing practice certification.

Brazil
Brazil expands use of regulatory reliance • Source: Shutterstock

Anvisa, the Brazilian medicines regulator, is developing new regulations that would allow it to rely on evaluations carried out by other regulators in its decision making on inspection processes and good manufacturing practice (GMP) certification.

Anvisa has just closed a consultation on a regulatory proposal for identifying equivalent foreign regulatory authorities whose inspections and certification it could rely on in the areas of active pharmaceutical

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