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Regulatory Affairs International

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The Italian Medicines Agency has informed production/import sites of medicines that in accordance with the “Compilation of Community Procedures Rev. 17”, the Manufacturing Site Authorization Office will issue authorizations for production/import (MIA) and Certificates for GMP compliance according to the guidelines provided in the “Interpretation of the Union Format for Manufacturer/Importer Authorization MIA”.

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We offer a stage to young graduates in scientific subjects specialized in GxP quality systems, to be employed in the pharmacovigilance sector.

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The New Zealand regulatory authority Medsafe has updated the procedures for the definitions of medical devices and drug as part of the merging with the Australian agency TGA, with the aim of align the country’s system with those of other world regulators. 

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Australia adopting EU guidelines

The Australian Regulatory Agency TGA has adopted some EU guidelines following a consultation within the Agency and with all relevant stakeholders including Industry and Consumers Groups. 

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