Starting August 19, 2024, Anvisa will implement new subject codes for the registration of biological products. This change is designed to enhance the management of processes and improve the accuracy of data collection. The update aligns with Brazil’s broader strategy for the development of the Health Economic-Industrial Complex (Ceis) under the Ministry of Health and strengthens monitoring for specific categories of biological products, particularly vaccines and blood derivatives.
Changes in Biological Product Categories
The current subject codes have been subdivided into distinct categories, allowing for more detailed monitoring and greater efficiency in processing applications. The new classification includes the following categories:
- Vaccines
- Hyperimmune Sera
- Blood Derivatives
- Biopharmaceuticals
- Monoclonal Antibodies
- Live/Attenuated/Dead Microorganisms
- Industrialized Allergenic Products
- Probiotics
These categories will replace the previous classification, which was based on the development and registration pathways of biological products, such as new biological products, comparability development pathways, and individual development pathways.
New and Current Subject Codes
Below is a detailed comparison of the current and new subject codes:
| Current Subject Codes | New Subject Codes |
|---|---|
| 1528 – BIOLOGICAL PRODUCT – New Product Registration | 12333 – BIOLOGICAL PRODUCT – New Product Registration – VACCINES |
| 12334 – BIOLOGICAL PRODUCT – New Product Registration – HYPERIMMUNE SERA | |
| 12335 – BIOLOGICAL PRODUCT – New Product Registration – BLOOD DERIVATIVES | |
| 12336 – BIOLOGICAL PRODUCT – New Product Registration – BIOPHARMACEUTICALS | |
| 12337 – BIOLOGICAL PRODUCT – New Product Registration – MONOCLONAL ANTIBODIES | |
| 12338 – BIOLOGICAL PRODUCT – New Product Registration – LIVE/ATTENUATED/DEAD MICROORGANISMS | |
| 10369 – BIOLOGICAL PRODUCT – Registration via Comparability Development | 12341 – BIOLOGICAL PRODUCT – BIOSIMILAR – Comparability Development Pathway – BIOPHARMACEUTICALS |
| 12342 – BIOLOGICAL PRODUCT – BIOSIMILAR – Comparability Development Pathway – MONOCLONAL ANTIBODIES | |
| 10370 – BIOLOGICAL PRODUCT – Registration via Individual Development | 12343 – BIOLOGICAL PRODUCT – Individual Development Pathway – VACCINES |
| 12344 – BIOLOGICAL PRODUCT – Individual Development Pathway – HYPERIMMUNE SERA | |
| 12345 – BIOLOGICAL PRODUCT – Individual Development Pathway – BLOOD DERIVATIVES | |
| 12346 – BIOLOGICAL PRODUCT – Individual Development Pathway – LIVE/ATTENUATED/DEAD MICROORGANISMS | |
| 1529 – BIOLOGICAL PRODUCT – Registration | 12339 – BIOLOGICAL PRODUCT – Registration of INDUSTRIALIZED ALLERGENIC PRODUCTS |
| 12340 – BIOLOGICAL PRODUCT – Registration of PROBIOTICS |
Impacts and Benefits
This new structure will streamline data collection and enhance Anvisa’s ability to monitor key indicators as outlined in its Strategic Planning. One of the primary benefits is improved tracking of Productive Development Partnerships (PDPs), with a new specific subject code for addenda, eliminating the need for multiple codes and simplifying the process.
Transition and Continuity
During the transition period, which lasts until August 31, 2024, the existing subject codes will remain active, allowing companies to adapt without disrupting their registration processes. After this date, the old codes will be deactivated, and Anvisa will gradually update pre-existing processes, requiring no additional action from the companies.
Conclusion
Companies involved in the registration of biological products should closely follow these changes to ensure compliance and efficiency in their operations. More information will be available on Anvisa’s Consultation Portal starting August 19, 2024.