Medicines regulators in Mexico and Argentina have agreed to exchange good manufacturing practices inspection certificates.
ANMAT, Argentina’s medicines regulator, and its Mexican counterpart, COFEPRIS, have agreed to exchange good manufacturing practice (GMP) reports as a means of driving regional trade and regulatory efficiency.
Through the cooperation, the agencies will develop a joint mechanism for validating GMP inspections conducted in both countries. This means...
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.
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.
With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be implemented.
