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.
Brazil and Argentina Join Talks To Create Latin American & Caribbean Regulator
The number of regulators formally agreeing to work towards creating a Latin American regulator is growing.
More from Latin America
• By
Brazil’s drug regulator ANVISA has also published its first post-marketing authorization monitoring reports on advanced therapies Yescarta, Zolgenma, Kymriah, Carvykti and Luxturna.
• By
Health technology assessment bodies in England, the US, Canada, Australia, the Netherlands and Colombia have joined forces to produce guidance for drug developers on using surrogate endpoints for cost-effectiveness analyses.
• By
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.
• By
Mexico is to establish a new regulatory framework that is in line with international standards to encourage domestic production of biosimilar medicines.
More from Geography
• By
The European Medicines Agency has recommended five drugs for EU-wide approval , including Averoa’s Xoanacyl for concomitant hyperphosphatemia. Two companies have withdrawn their marketing authorization applications.
• By
Eli Lilly’ will request a re-examination after the European Medicines Agency declined to recommend its Alzheimer’s disease drug Kisunla for EU approval.
• By
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.