1. Agência Nacional de Vigilância Sanitária www.anvisa.gov.br Second Latin American Congress of Clinical Research, Mexico City, September 29 – October 1, 2003 Current Regulatory Climate in Latin America - the case of BRAZIL Sérgio Nishioka, MD, PhD ANVISA

2. Agência Nacional de Vigilância Sanitária www.anvisa.gov.br Background (1) 1996-1997: National Health Council (Ministry of Health) publishes legislation regarding clinical research in Brazil: focus on ethics 1998: Portaria 911 lists documents and procedures required for the approval of clinical research projects in Brazil

3. Agência Nacional de Vigilância Sanitária www.anvisa.gov.br Background (2) 1999: ANVISA is created as a regulatory agency (subordinated to the Ministry of Health but somewhat independent) The Office of New Drugs, Research and Clinical Trials (GEPEC) deals with clinical research within ANVISA

4. Agência Nacional de Vigilância Sanitária www.anvisa.gov.br ANVISA in 2003 New direction Director (diretor-presidente) Deputy Manager of GEPEC Major (ongoing) changes in legislation regarding drugs in general Changes in the registration of new drugs and improvement of legislation on clinical research

5. Agência Nacional de Vigilância Sanitária www.anvisa.gov.br New roles of GEPEC Registration of new drugs Registration of phytomedicines Register renewal of “former new drugs” (reference drugs) Assessment of evidence of efficacy and safety of other reference drugs

6. Agência Nacional de Vigilância Sanitária www.anvisa.gov.br New roles of GEPEC Clinical Research Package of new legislation addressing: Documentation and procedures (Revision of Portaria 911) Monitoring of adverse events CROs Inspection Regulation of Research Centers

7. Agência Nacional de Vigilância Sanitária www.anvisa.gov.br New legislation on clinical research: advantages (1) Documentation and procedures Less bureaucratic Introduces elements of GCP Adverse events monitoring Creates instruments and rules for pharmacovigilance CROs Legislation previously inexistent

8. Agência Nacional de Vigilância Sanitária www.anvisa.gov.br New legislation on clinical research: advantages (2) Inspection Regulation of Research Centers Allows implementation of inspections Ensures better quality control of studies Ensures safety of study subjects

9. Agência Nacional de Vigilância Sanitária www.anvisa.gov.br Current situation and agenda (1) First draft: pre-consultation (informal) August/September 2003 Second draft: initial analysis by ANVISA’s Collegiate Board of Directors Sent to public consultation (official) October/November 2003

10. Agência Nacional de Vigilância Sanitária www.anvisa.gov.br Current situation and agenda (2) Third draft: in-depth analysis and approval by ANVISA’s Collegiate Board of Directors Assessment by the Office of the Attorney (Procuradoria) December 2003 / February 2004 Publication

11. Agência Nacional de Vigilância Sanitária www.anvisa.gov.br ANVISA’s view of clinical research in Brazil (1) It is of interest that good quality clinical research is carried out in Brazil Provides pre-registration data in Brazilians Provides training for Brazilian investigators Gives jobs

12. Agência Nacional de Vigilância Sanitária www.anvisa.gov.br ANVISA’s view of clinical research in Brazil (2) Safety of the subjects and other ethical issues are major determinants for the classification of clinical trial protocols as of good quality Good clinical research should be supported Support and orientation should be given to investigators interested in studying Brazilian drugs but the standards for clinical research should be the same

13. Agência Nacional de Vigilância Sanitária www.anvisa.gov.br Comments and questions are welcome sergio.nishioka@anvisa.gov.br or gepec@anvisa.gov.br

14. Agência Nacional de Vigilância Sanitária www.anvisa.gov.br Thank you!