Impact of trial design on GCP inspections - World Health Organization

14 th International Conference <strong>of</strong> Drug Regulatory Authorities
<strong>Impact</strong> <strong>of</strong> <strong>trial</strong> <strong>design</strong> on GCP
Agência Nacional
de Vigilância Sanitária
inspections
Laura Gomes Castanheira
Clinical Trials and New Drugs Coordination
Safety and Efficacy Evaluation Office
Head
www.anvisa.gov.br

CLINICAL TRIALS TO BE CONDUCTED
IN BRAZIL WITH DRUGS OR
MEDICAL DEVICES REQUIRE
AUTHORIZATION FROM ETHICAL
INSTANCE AND ANVISA
Agência Nacional
de Vigilância Sanitária
www.anvisa.gov.br

ETHICAL OVERSIGHT - SYSTEM OF ETHIC
COMMITTEE
Agência Nacional
de Vigilância Sanitária
CEP/CONEP SYSTEM
Regulated by NATIONAL HEALTH COUNCIL
• National Commission <strong>of</strong> Ethic in Researches –
CONEP - It is an advisory, deliberative,
regulatory, educational, independent organ
reporting to the National Council <strong>of</strong> Health-
MAJOR INSTANCE- MANDATORY FOR
INTERNATIONAL COOPERATION
• ETHIC COMMITTEES IN RESEARCH – CEPs – LOCAL
INSTANCE
www.anvisa.gov.br

REGULATION FOR BIOMEDICAL RESEARCH IN
HUMAN SUBJECTS
LAW 6360/76 - HEALTH SURVEILLANCE
RDC 305/2002
BSE
RDC 68/2003
BSE
RDC 350/2005
Imports
Agência Nacional
de Vigilância Sanitária
R CNS 370/2007
CEP-CONEP
RDC 39/2008
Clinical Trials
R CNS 346/2005
CEP-CONEP
R CNS 196/1996
BIOMEDICAL RESEARCH IN
HUMAN SUBJECTS
R CNS 251/1997
New medicines
R CNS 292/1999
International
Cooperation
R CNS 340/2004
Human Genetics
R CNS 301/2000
Placebo
www.anvisa.gov.br

GUIDELINES FOR, NON CLINICAL
STUDIES, GCP, GMP AND GLP
GUIDE TO NON-CLINICAL SAFETY STUDIES REQUIRED TO
DEVELOP NEW DRUGS- ANVISA website
GOOD MANUFACTURING PRACTICES: RDC 17/2010
GOOD LABORATORY PRACTICES: OECD Principles <strong>of</strong> Good Laboratory
Practice / HANDBOOK - GOOD LABORATORY PRACTICE (GLP) – WHO
(Quality practices for regulated non-clinical research and development)
GOOD CLINICAL PRACTICES: DOCUMENT OF THE AMERICAS
GOOD CLINICAL PRACTICES INSPECTIONS: NORMATIVE
INSTRUCTION 4/2009.
Agência Nacional
de Vigilância Sanitária
www.anvisa.gov.br

SYSTEM ESTABLISHED FOR CLINICAL TRIALS
APPROVAL
Agência Nacional
de Vigilância Sanitária
INSTANCES FOR SUBMISSION OF
CLINICAL TRIALS PROTOCOLS IN BRAZIL
ETHIC INSTANCE
INSTITUTIONAL ETHICS COMMITTEES
/ CONEP
HEALTH SURVEILLANCE
INSTANCE
TECHINCAL INSTANCE
ANVISA
www.anvisa.gov.br

•INVESTIGATOR
•CRO
•SPONSOR
Agência Nacional
de Vigilância Sanitária
APPLICATION FOR
CLINICAL TRIALS
INSTITUTIONAL
ETHICS COMMITTEES
LOCAL ETHIC COMMITTEE APPROVAL
APLICATION + LOCAL ETHIC COMMITTEE APPROVAL
CONEP
ANVISA
www.anvisa.gov.br

REGULATORY OVERSIGHT OF CLINICAL
TRIALS POST AUTHORIZATION
•Protocol amendments should be submitted to ANVISA and
authorized by the ethics committee prior to implementation
•The sponsor must submit annual and final reports to ANVISA
The non-submission <strong>of</strong> annual reports implies the immediate
cancellation <strong>of</strong> the CE
Agência Nacional
de Vigilância Sanitária
www.anvisa.gov.br

REGULATORY OVERSIGHT OF CLINICAL
TRIALS-
GCP INSPECTIONS
• ANVISA conduct inspections at the national <strong>trial</strong>
sites to verify the compliance with current Brazilian
legislation and Good Clinical Practices.
•Ethical instance can be part <strong>of</strong> GCP inspection team
• GCP multicentric studies- Brazil as a <strong>trial</strong> site
International studies***
Agência Nacional
de Vigilância Sanitária
www.anvisa.gov.br

MARKETING AUTHORIZATION x
MULTICENTRICAL STUIDES x GCP
INSPECTIONS
•CLINICAL TRIAL MUST BE APROVED BY NRA OF ORIGIN
COUNTRY
•GCP INSPECTION (ANVISA OR NRA OF ORIGIN COUNTRY) IS
NOT A MANDATORY REQUIREMENT DURING MARKETING
AUTHORIZATION ASSESSMENT.
•RESULTS VALIDATION x GCP INSPECTIONS
Agência Nacional
de Vigilância Sanitária
www.anvisa.gov.br

INTERNATIONAL COOPERATION
Agência Nacional
de Vigilância Sanitária
•COOPERATION PROGRAM WITH OTHER NRAs
2008/2009
TECHNICAL INTERCHANGE WITH CECMED (CUBA), WITH A FOCUS ON THE
GCP INSPECTION PROGRAM.
2008/2009/2010
GCP INSPECTION TRAININIG PROGRAMS - DCVRN
2009/2010
STRENGHTENING REGULATORY AUTHORITIES IN MEDICINES AND
BIOLOGICALS- CR50.R9-PAHO
2009/2010
CONFIDENTIAL AGREEMENTS –HEALTH CANADA AND FDA.
2010
WORKSHOP ON THE DRAFT REFELCTION PAPER ON ETHICAL AND GCP
ASPECTS OF CLINICAL TRIALS
www.anvisa.gov.br

laura.castanheira@anvisa.gov.br
pesquisaclinica@anvisa.gov.br
Agência Nacional
de Vigilância Sanitária
www.anvisa.gov.br
www.anvisa.gov.br