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International Clinical Trials Conference Washington, DC, November 10-12, 2003

International Clinical Trials Conference Washington, DC, November 10-12, 2003. National Regulatory Agencies – Brazil Sérgio Nishioka, MD, PhD ANVISA. 1996-1997: National Health Council (Ministry of Health) publishes legislation regarding clinical research in Brazil: focus on ethics

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International Clinical Trials Conference Washington, DC, November 10-12, 2003

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  1. International Clinical Trials ConferenceWashington, DC, November 10-12, 2003 National Regulatory Agencies – Brazil Sérgio Nishioka, MD, PhD ANVISA .

  2. 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 Background (1)

  3. 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 Background (2)

  4. New direction Major (ongoing) changes in legislation regarding drugs in general Changes in the registration of new drugs and improvement of legislation on clinical research ANVISA in 2003

  5. Registration of phytomedicines Register renewal of “former new drugs” (reference drugs) Assessment of evidence of efficacy and safety of other reference drugs New roles of GEPECRegistration of new drugs

  6. Package of new legislation addressing: Documentation and procedures (Revision of Portaria911) Monitoring of adverse events CROs Inspection Regulation of Research Centers New roles of GEPECClinical Research

  7. Documentation and procedures Less bureaucratic Introduces elements of GCP Adverse events monitoring Creates instruments and rules for pharmacovigilance CROs Legislation previously inexistent New legislation on clinical research: advantages (1)

  8. Inspection Regulation of Research Centers Allows implementation of inspections Ensures better quality control of studies Ensures safety of study subjects New legislation on clinical research: advantages (2)

  9. First draft: pre-consultation (informal) September/October 2003 Second draft: initial analysis by ANVISA’s Collegiate Board of Directors Public consultation (official) November 2003 / January 2004 Current situation and agenda (1)

  10. Third draft: in-depth analysis and approval by ANVISA’s Collegiate Board of Directors Assessment by the Office of the Attorney (Procuradoria) February/March 2004 Publication Current situation and agenda (2)

  11. According to schedule Revision of Portaria 911 Adverse events CROs Delayed Inspection Research Centers Current situation and agenda (3)

  12. 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 ANVISA’s view of clinical research in Brazil (1)

  13. Safety of the subjects and other ethical issues are major determinants for the classification of clinical trial protocols as of good quality Support and orientation should be given to investigators interested in studying Brazilian drugs, but the standards for clinical research should be the same ANVISA’s view of clinical research in Brazil (2)

  14. Comments and questions are welcome! sergio.nishioka@anvisa.gov.br or gepec@anvisa.gov.br

  15. Thank you!

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