Mexico aims to speed up the registration of generics and biosimilars.
Mexico’s medicines regulator, COFEPRIS, says it is streamlining the registration of generic medicines and biosimilars by recognizing registration studies conducted in other countries. The move is part of Mexico’s shift towards greater regulatory reliance.
Amendments have been made to Regulation NOM-177-SSA1-2013, which lays out the criteria for clinical trial design so that studies show...
Brazilian regulator Anvisa is relying on the decisions of its foreign counterparts as a means of ensuring more quality medicines are made available in the country.
Brazil has also published its recent regulatory reliance regulations in English, a move designed to increase confidence in its decisions as it presses on with aligning its national practices with global best practices.
The deal comes at a time when Latin American countries are increasingly looking to improve the regulatory environment for pharmaceuticals and move towards greater convergence.
Mexico is to establish a new regulatory framework that is in line with international standards to encourage domestic production of biosimilar medicines.
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A new research ethics review system for multi-site clinical trials in Canada is expected to help improve study start-up times, avoid unnecessary duplication and boost the country’s competitiveness on a global stage.
