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Sérgio Nishioka, MD, PhD ANVISA

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.

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Sérgio Nishioka, MD, PhD ANVISA

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  1. Second Latin American Congress of Clinical Research, Mexico City, September 29 – October 1, 2003Current Regulatory Climate in Latin America- the case of 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 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 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) August/September 2003 Second draft: initial analysis by ANVISA’s Collegiate Board of Directors Sent to public consultation (official) October/November 2003 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) December 2003 / February 2004 Publication Current situation and agenda (2)

  11. 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)

  12. 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 ANVISA’s view of clinical research in Brazil (2)

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

  14. Thank you!

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