Brazil: Updates to Biologics Regulations Proposed
| Posted: 9 July 2012
By Ansis Helmanis, RegLink
Brazil’s National Health Surveillance Agency (Anvisa) has opened a public consultation on proposed amendments (41/2012) to the regulation of biological products in Brazil.
The proposed changes, released 4 July 2012, address post-registration revisions and additions, the suspension and reactivation of registration and the cancellation of registration of biological products. A second proposal (42/2012) updates RDC Resolution 50/20, which sets forth the procedures and conditions for studies of stability for the registration or post-registration changes of biologicals.
ANVISA - Public consultation update regulations for organic products
More Breaking News from RegLink