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Regulators ‘more efficient at approving drugs’

January 19, 2015
Research and Development, Sales and Marketing EMA, EMA), FDA, Health Canada, PMDA)., Pharmaceutical and Medical Devices Agency, Swissmedic, TGA, approvals, cirs, reuters

Global regulatory bodies have become faster at approving new drug products more quickly and consistently, according to a new analysis …

Shared API inspections project declared a success

August 9, 2011
Manufacturing and Production API, EMA, FDA, TGA, pharma manufacturing news, regulatory inspections

A two-year facility inspection programme carried out by regulators in the USA, Europe and Australia has been deemed a success …

Shared API inspections project gains traction

October 26, 2010
Manufacturing and Production API, EDQM, EMA, FDA, TGA, manufacturing compliance, pharma manufacturing, regulatory affairs, regulatory inspections

A three-way initiative between regulatory authorities in the EU, US and Australia on the inspection of facilities making active pharmaceutical …

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