Moves to widen GMP certificate recognition are in line with World Health Organization recommendations on Good Reliance Practices and with the Mexican government’s strategy for regulatory certainty for the pharmaceutical sector, says the country’s drugs regulator.
Mexico’s medicines regulator, Cofepris, is now recognizing good manufacturing practice certificates for manufacturers producing biologic medicines in other countries, including new innovative products and biosimilars.
Specifically, Cofepris will recognize GMP certificates issued by authorities accredited by the World Health Organization (WHO)/Pan American Health Organization (PAHO)...
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.
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.
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.
