Mexico’s regulator, Cofepris, wants to drive local production and development of biosimilar medicines to increase access through a new regulatory and operational framework for these products. The plans include the creation of several new bodies, including a new Council for National Pharmaceutical Development.
The announcement on 9 February by Cofepris head Alejandro Svarch Pérez follows recent moves to increase access to biosimilars and generics by recognizing registration studies conducted abroad that have been evaluated by World Health Organization-approved authorities with standards that are equal to or better than those of Cofepris
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