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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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s rgio nishioka md phd anvisa

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

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

Background (1)
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

Background (2)
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

ANVISA in 2003
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

New roles of GEPECRegistration of new drugs
new roles of gepec clinical research
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
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

New legislation on clinical research: advantages (1)
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

New legislation on clinical research: advantages (2)
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

Current situation and agenda (1)
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

Current situation and agenda (2)
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

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

ANVISA’s view of clinical research in Brazil (2)
comments and questions are welcome

Comments and questions are welcome

sergio.nishioka@anvisa.gov.br

or

gepec@anvisa.gov.br