Regulatory requirements for the acceptance of foreign comparator products in the participants of the International Generic Drug Regulators Programme

Author(s): Alfredo García Arieta, PhD

Submitted: 4 March 2019; Revised: 25 April 2019; Accepted: 27 April 2019; Published online first: 30 April 2019 The availability of quality generic drug products plays an increasingly important role in promoting access to medicines worldwide and in helping to address rising healthcare costs. This, however, has led to significant pressures on medicines regulatory authorities […]

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