On April 5, the National Health Surveillance Agency (Anvisa) launched a public consultation on a proposed regulation for the registration of less complex biological products. The objective is to inform the regulation through contributions from citizens, social entities and sector representatives. The deadline for participating in the consultation is June 3, 2019.
The text under consultation establishes the minimum requirements for the registration of less complex biological products in the country, with a view to safeguarding the quality and efficacy of these medicines. This includes requirements for meeting the definition of the type of product to be covered by the regulation. For example, it establishes that drugs must be biomedicines that do not involve recombinant-DNA technology, meaning they are not obtained through biotechnological procedures. Injectables, meanwhile, would not be covered under the proposed regulation.
The text also sets out the technical steps for companies to submit applications for registration including the necessary documentation. In addition, it vests Anvisa with the authority to demand, at any time and at its discretion, additional proof of identity and quality of the components of the registered biological product, and/or to require new studies to prove its efficacy and clinical safety.
Those interested in participating in the consultation may do so through the electronic form on the Anvisa website. The deadline for this is June 3, 2019.