Agência Nacional de Vigilância Sanitária - Anvisa Agência Nacional de Vigilância Sanitária - Anvisa Meiruze Freitas Superintendence of Syntetic Dugs and Biological Products - SUMED Brazilian Health Regulatory Agency ANVISA Tokyo – September, 10 th 2015 Enhancing Review Efficiency
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Enhancing Review Efficiency · Agência Nacional de Vigilância Sanitária - Anvisa Agência Nacional de Vigilância Sanitária - Anvisa Meiruze Freitas Superintendence of Syntetic
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Agência Nacional de Vigilância Sanitária - Anvisa
Agência Nacional de Vigilância Sanitária - Anvisa
Meiruze FreitasSuperintendence of Syntetic Dugs and
Biological Products - SUMEDBrazilian Health Regulatory Agency ANVISA
Tokyo – September, 10th 2015
Enhancing ReviewEfficiency
Agência Nacional de Vigilância Sanitária - Anvisa
SUMED´s Flow Chart
SUPERINTENDENCE OF DRUGS ANDBIOLOGICAL PRODUCTS (SUMED)
GENERAL OFFICE OF DRUGS (GGMED)
GENERAL OFFICE OF BIOLOGICAL PRODUCTS (GGPBS)
Labeling Department (CBREM)
Appeal Decisions Department (COREC)
IP Department (COOPI)
Brazilian Pharmacopeia
Department COFAR)
Clinical Trials Department (COPEC)
Agência Nacional de Vigilância Sanitária - Anvisa
SUMED´s Flow Chart
GENERAL OFFICE OF DRUGS (GGMED)
Office of Safety and Efficacy Evaluation
(GESEF)
Office of Drug Registration
Evaluation(GRMED)
Office of Post‐ Approval Changes Evaluation
(GEPRE)
Department of Therapeutic
Equivalence (CETER)
Department of Specific and Notified
Drugs (COGEN)
API Department (COIFA)
Herbal Drugs Department (COFID)
Agência Nacional de Vigilância Sanitária - Anvisa
SUMED´s Flow Chart
GERENAL OFFICE OF BIOLOGICAL PRODUCTS, BLOOD, TISSUES, CELLS AND ORGANS (GGPBS)
Office of Biological Products(GPBIO)
Office of blood, tissues, cells and organs (GSTCO)
Agência Nacional de Vigilância Sanitária - Anvisa
General Objectives
To harmonize technical and administrativeprocedures;
To create offices according to their specificknowledge;
To promote more transparency on the Agency´sdecisions;
To reduce the review time by simplifying the workprocess.
Agência Nacional de Vigilância Sanitária - Anvisa
Evaluation of Drugs Applications, Post Approval ChangesApplications, Drugs Registrations Renewal;
“in situ” inspections of the above applications‐Implementation of audits on review process ;
Inspections on Pharmaceutical Equivalence andBioequivalence/Bioavailability Centers;
Evaluation of Safety and Efficacy (clinical trials);
Separating applications according to thecomplexity and risk;
Gradual implementation of electronicsubmission starting with new drugs;
Establishing previous submission meetingstarting to new drugs;
Reduction in review time by work process changes
Agência Nacional de Vigilância Sanitária - Anvisa
Reduction in review time by work process changes
“In situ" analysis of registration or post‐registration requests;
– Allows rapid exchange of information between the analyst and the regulated industry.
Agência Nacional de Vigilância Sanitária - Anvisa
International Cooperation/Groups
United States, Canada, China, Japan, Portugal, EMA, Cuba and ArgentinaPAHO – Pan American Health OrganizationWHO – World Health OrganizationPMDA – Pharmaceuticals and Medical Devices AgencyIGDRP – International Generic Drug Regulators Programs
Agência Nacional de Vigilância Sanitária - Anvisa
Contacts
Web Site: http://www.anvisa.gov.brCall Center:
0800 642 9782. Free call from any state of Brazil.
Working hours from 7am to 7 pm, Monday to Friday, except holidays. Contact us: