Brazil

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.

Generics Bulletin recaps the most recent regulatory news from across the world.

Regulators in Europe and the US have demonstrated a commitment to providing guidance that will make decentralized and point-of-care manufacturing a reality, the CSO of GermFree, a company that provides mobile and modular cleanrooms for manufacturing advanced therapies, tells the Pink Sheet.

Brazil looks to EU, UK and others for inspiration on introducing a regulatory sandbox.

Following its recently announced leadership changes, Hyloris has made two announcements linked to the marketing of its combined pain therapy Maxigesic IV in Brazil and the US.

Generics Bulletin recaps the most recent regulatory news and updates from across the world.

A new pilot aims to take Brazil closer to ‘digital transformation.’

A new federal law aims to promote the conduct of trials and speed up access to innovative drugs in Brazil.

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.

The 25th IMDRF meeting in March 2024 agreed that regulatory reliance models save resources, encourage innovation, bring devices to the market faster and boost patient access. Singapore and Thailand have operated a model of mutual regulatory reliance for three years. Thailand also recently broached deeper collaboration with Brazil’s Anvisa.