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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);
Drafting and reviewing legislation.
Performance of SUMED
Agência Nacional de Vigilância Sanitária - Anvisa
Team Reviewing at SUMED
Health Regulation Experts
Regulation Technicians
Administrative Personnel
BiologistsBiomedicsLawyers
Pharmacists PhysiciansStatisticianChemistsEngineers
Agência Nacional de Vigilância Sanitária - Anvisa
Good Work Practices
SUMED
Transparency
Legislation Review
Information System
Changing the work process
Sharing responsabilities
Agência Nacional de Vigilância Sanitária - Anvisa
Anvisa´s website - Transparency
Information about
registered products
Information on the dossiers
analysis queue at ANVISA website
Talk with the Agency
Agência Nacional de Vigilância Sanitária - Anvisa
Anvisa´s website - Transparency
Approval letter
Information on the
approved clinical trials
labeling of
medicines
registered and sold in Brazil
Agência Nacional de Vigilância Sanitária - Anvisa
Total 1.148 medicamentos registrados
Channels of communication
Agência Nacional de Vigilância Sanitária - Anvisa
Drug Registration
•In Brazil, drugs need to be registered.
•The registration must be renewed every five years.
•Categories of Drugs registered in Brazil:
“New” drugs (innovative and others)Synthetic and semi-synthetic drugs
Biologicals (includes biossimilars)
Herbal medicines
“Copies” (Synthetic and semi-synthetic drugs)Generic Drugs
Similar Drugs (“brand generic”)
Agência Nacional de Vigilância Sanitária - Anvisa
Drug Registration – Category of medicines
CATEGORY OF DRUGS
NEW DRUGS
BIOLOGICALS
HERBAL MEDICINES
GENERIC DRUGS
HOMEOPHATICS
NOTIFIED
SPECIFIC DRUGS
SIMILAR
Agência Nacional de Vigilância Sanitária - Anvisa
Drug Registration
Each of categories have their specific legislations and requirements
DRUG REGISTRATI
ON
QUALITY EFICACY
SAFETY LEGAL DOCUMENTATION
Agência Nacional de Vigilância Sanitária - Anvisa
Drug Registration – main requirements
Company Authorization (AFE)
Good Manufacturing Practices (GMP certificates)
Information about API used – drug master file / DCB (CommonBrazilian Nomination)
Production Report (quanti/qualitative formula, role of each excipiente,production details, sumarized validation report)
Quality Control Report
Analythical Method Validation
Stability studies of 3 pilot batches (Zone IVb)
Pharmaceutical equivalence and bioequivalence for “copies” (CenterCertified by Anvisa)
Clinical trials for “news”
Agência Nacional de Vigilância Sanitária - Anvisa
Drug Registration – legislation
Registration ResolutionSynthetic and semi-synthetic drugs (news, generics and similars)
RDC Nº. 60/2014
Homeopathic Drug RDC Nº. 26/2007
Herbal Medicines RDC Nº. 26/2014
Biological Drug RDC Nº. 55/2010
Specific Drugs RDC Nº 24/2011
Notified RDC Nº 199/2006
Post-Registation Resolution
Drug Post Registration RDC Nº 48/2009
Drug Post Registration for biologicals RDC Nº 24/2013
Agência Nacional de Vigilância Sanitária - Anvisa
Drug Registration – main complementary legislation
Subject Resolution
Bovine spongiform encephalopathy (BSE) RDC Nº 305/2002 and RDC Nº 68/2003
List of Groups and Specific Therapeutic Indication RDC nº 138/2003
Analytical and Bioanalytical Validation Guideline RE Nº 899/2003 and RDC Nº 27/2012
Stability studies guideline RE Nº 1/2005
Leaflets RDC Nº 47/2009
Labeling RDC Nº 71/2009
Pilot Batches Notification Guideline IN Nº 02/2009
Pharmaceutical equivalence and dissolution profile RDC Nº 31/2010
BE/BA studies exemption guideline RDC Nº 37/2011
Stability studies for biological products RDC Nº. 50/2011
Agência Nacional de Vigilância Sanitária - Anvisa
Drug Registration - Legislation Review
Focus on health risk;
Sharing responsibility with the regulated sector;
Regulatory Convergence with international standards.
Agência Nacional de Vigilância Sanitária - Anvisa
• Clarifying Anvisa’s technical requirements;• New product presentation;• Regulatory and technical advice;• Enterprises associations representatives.
http://www10.anvisa.gov.br/Parlatorio/login.seam?cid=184
Face to face meetings (no fee is required)
Agência Nacional de Vigilância Sanitária - Anvisa
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:
http://www.anvisa.gov.br/institucional/faleconosco/FaleConosco.asphttp://portal.anvisa.gov.br/wps/portal/anvisa/ouvidoria
Twitter: @anvisa_oficialE‐mail: sumed@anvisa.gov.br
Phone number: + 55 (61) 3462 6724
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