Workshop Session 3 International Session: Focus on Latin America. Laura Castanheira Brazilian Health Surveillance Agency ANVISA

Transcrição

1 Workshop Session 3 International Session: Focus on Latin America Laura Castanheira Brazilian Health Surveillance Agency ANVISA Jan, * 2014

2 Regulatory Aspects for Biologicals in Brazil Laura Gomes Castanheira Brazilian Health Surveillance Agency

3 Development of Biological Products Regulation Law 6360/1976 general regulation about medicines, including biological products RDC 80/2002 first regulatory act, specific for biological products. Same approach for new products and copies

4 Development of Biological Products Regulation ANVISA RDC 315/2005 second regulation regarding biological products. Same approach for new products and copies, with more detailed information RDC 55/2010 current regulation. Specific approach for copies of biologicals

5 Types of Biological Products 1.Vaccines; 2. Hiperimmune sera; 3. Blood products; 4. Biomedicines: - medicines obtained from biological fluids or animal tissues; - medicines from biotechonological procedures.

6 Types of Biological Products 5. Monoclonal antibodies; 6. Medicines containing live, attenuated or dead microorganisms; 7. Probiotics; 8. Allergens.

7 Regulatory acts concerning biological products RDC 47/09 RDC 60/12 Package insert Law 6360/76 General Regulation RDC 46/00 Blood products RDC 71/09, RDC 168/02 RDC 61/12 Label RDC 81/08, RDC 234/05, RDC 38/10,RDC 58/12 Import RDC 55/10 Specific Guidelines REGISTRATION RDC 49/11, RDC 24/13 POST-APPROVAL RDC 233/05 Allergenics RDC 323/03 Probiotics Portaria 174/96 Antivenom serums RDC 234/05 Quality Control RDC 17/10 Good Manufacturing Practices RDC 50/11, RDC 25/13 Stability

8 Classification of Biological Products I New Biological Product: is the biological product containing molecule with known biological activity, still not registered in Brazil and that has undergone all stages of manufacturing RDC 55/2010

9 Classification of Biological Products II Biological product: is the biological drug that is not new or is known, containing molecule with known biological activity, already registered in Brazil and that has undergone all stages of manufacturing RDC 55/2010

10 Regulatory Pathways Biological product New biological product Individual route of development Comparability development Individual route of development Complete dossier Complete dossier Comparative Phase III Non innovative biological product Comparability exercise Quality, Safety, Efficacy Biosimilar

11 Partnerships INCA National Cancer Institute Brazil Brazilian Rheumatology Society National Network of Clinical Studies Technical Advisory Committee for Biologicals (CATEBIO)

12 Guidelines ANVISA Comparability Exercise Guideline

13 Guidelines ANVISA Heparin Guideline

14 Guidelines ANVISA Interferon alpha Guideline

15 Guidelines ANVISA Guideline for Elaboration of Clinical Study Reports

16 Guidelines Future perspectives etanercept rituximab Non clinical studies guideline Establishment and evaluation of cell substrates used in production of biological

17 Thank you for your attention!