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Regulatory Focus™ > News Articles > Brazil Drops International GMP Inspection Proposal

Brazil Drops International GMP Inspection Proposal

Posted 24 January 2013 | By Louise Zornoza

The Board of Brazil's national regulatory agency, Anvisa, has abandoned a draft resolution that proposed how the regulatory agency would conduct overseas current good manufacturing practice (CGMP) inspections at medical device and in vitro diagnostic (IVD) manufacturing sites.

Regulators cited comments indicating that the high cost of the inspections would outweigh the benefits of the proposal for the withdrawal of the draft resolution.

Moreover, elements of the earlier proposal are now covered by the recently launched Public Consultation 02/2013 on the conditions for granting Certificates of GMP and Good Distribution Practice (GDP) and Storage.


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