The number of regulators formally agreeing to work towards creating a Latin American regulator is growing.
Two of Latin America’s most well-established regulators, Brazil’s Anvisa and Argentina’s Anmat, have signed up to moving ahead to create a medicines regulator for Latin America and the Caribbean. The addition of the two influential bodies could help drive the project forward, after it was initiated by three other regulatory agencies earlier this year.
Cofepris, Invima and Cecmed, regulators in Mexico, Colombia and Cuba respectively, signed the Acapulco Declaration In April to formalize talks...
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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
