Medicines regulators from the Pacific Alliance have taken a step towards greater regional regulatory harmonization in a bid to make registration of medicines faster.
Regulators from the Pacific Alliance in Mexico, Colombia and Chile – COFEPRIS, INVIMA and ISP respectively – have taken a step towards greater regulatory harmonization and have signed an agreement that they say will speed up the registration process for medicines.
At a meeting in Medellin, Colombia, the three regulators also set up a permanent technical team, the aim of which...
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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
