Brazil’s National Health Regulatory Agency (ANVISA), has introduced new subject codes to facilitate the registration and updating of pre-pandemic influenza vaccines. These codes align with Resolution RDC No. 846/2024, which outlines the conditions and procedures for registering and updating vaccine strains of this type.
Background
Pre-pandemic vaccines play a crucial role in public health preparedness. They target influenza strains that have not yet caused sustained human-to-human transmission but have the potential to do so. By having pre-evaluated and registered vaccine strains, regulatory agencies can expedite the development and availability of specific vaccines when needed.
The Importance of Subject Codes
ANVISA has established specific subject codes for companies seeking to register and update pre-pandemic influenza vaccines.
Initial Registration (Pre-Pandemic Form): Companies should use the subject code 12284 – BIOLOGICAL PRODUCT – Registration of Pre-Pandemic Influenza Vaccine for the initial registration of the vaccine in its pre-pandemic form. At this stage, the vaccine does not need to have an exact active composition, unlike a typical vaccine.
Future Updates (Conversion to Pandemic Form): Depending on the situation, companies can later update the registered strain and convert the pre-pandemic vaccine into a pandemic vaccine. To achieve this, they should submit a petition using subject code 12285 – BIOLOGICAL PRODUCTS – Update of Pre-Pandemic Influenza Vaccine Registration.
Document Requirements
The necessary documents for each type of petition are outlined in Resolution RDC No. 846/2024. Companies can also verify the specific requirements through the ANVISA’s Consultation Portal. This proactive approach ensures that ANVISA remains committed to promoting and safeguarding public health.
These new subject codes streamline the regulatory process, allowing for swift responses to potential health emergencies. By anticipating influenza strains with pandemic potential, ANVISA continues to fulfill its mission of protecting the well-being of the population.
