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National Agency of Health Surveillance www.anvisa.gov.br Ministry of HealthMinistry of Health
THE ROLE OF ANVISA IN THE ROLE OF ANVISA IN REGULATING AND PROMOTING REGULATING AND PROMOTING SOCIAL WELFARE IN HEALTHSOCIAL WELFARE IN HEALTH
Cássio Nascimento MarquesCássio Nascimento MarquesSpecialist in Health Regulation and Specialist in Health Regulation and
SurveillanceSurveillance
INTERNATIONAL SEMINAR – ANTI-HIV VACCINE INTERNATIONAL SEMINAR – ANTI-HIV VACCINE RESEARCH: ETHICAL AND REGULATORY ISSUESRESEARCH: ETHICAL AND REGULATORY ISSUES
Brasília/DF, Brazil, 04-05 October 2006Brasília/DF, Brazil, 04-05 October 2006
National Agency of Health Surveillance www.anvisa.gov.br Ministry of HealthMinistry of Health
CONCEPTUAL ASPECTS
ANVISA: Special government agency linked to the Ministry of Health through a Management Contract
Regulatory agencies as inspecting organizations (“police power”)
Promotion and protection of the population’s health (collectivity interests)
National Agency of Health Surveillance www.anvisa.gov.br Ministry of HealthMinistry of Health
REGULATION ACTIVITY
Regulation: administrative activity of an intervening State
Disciplining, inspecting, controlling Establishing rules Target: public or private
organizations
National Agency of Health Surveillance www.anvisa.gov.br Ministry of HealthMinistry of Health
POLITICAL ASPECTS
Social welfare: Focus on social-democracy and the modern State concept
“...every individual would have the right, from birth, to a set of goods and services which should be supplied directly via the State or indirectly, through its power of regulation over civil society. (...)” (Brazilian Ministry of External Relations)
National Agency of Health Surveillance www.anvisa.gov.br Ministry of HealthMinistry of Health
HISTORY BACKGROUND
Health Reform: Federal Constitution and specific Statutory Laws
Administrative Reform – the regulatory State
Health surveillance-related Laws in force in Brazil: Law 6,360/1976 and Decree 79,094/1977
Health Surveillance in construction – specific Regulations: RDC´s and others
National Agency of Health Surveillance www.anvisa.gov.br Ministry of HealthMinistry of Health
FEDERAL CONSTITUTION OF 1988
Article 196 – Health is a right of all and a duty of the State and shall be guaranteed by means of social and economic policies aimed at reducing the risk of illness and other hazards and at the universal and equal access to actions and services for its promotion, protection and recovery.
National Agency of Health Surveillance www.anvisa.gov.br Ministry of HealthMinistry of Health
FEDERAL CONSTITUTION OF 1988
Article 197 – Health actions and services are of public importance, and it is incumbent upon the Government to provide, in accordance with the law, for their regulation, supervision and control, and they shall be carried out directly or by third parties and also by individuals or private legal entities.
National Agency of Health Surveillance www.anvisa.gov.br Ministry of HealthMinistry of Health
FEDERAL CONSTITUTION OF 1988FEDERAL CONSTITUTION OF 1988
Article 200 – It is incumbent upon the unified health system, in addition to other duties, as set forth by the law:I - to supervise and control proceedings, products and substances of interest to health and to participate in the production of drugs, equipments, immunobiological products, blood products and other inputs;II - to carry out actions of health and epidemiologic vigilance as well as those relating to the health of workers;
National Agency of Health Surveillance www.anvisa.gov.br Ministry of HealthMinistry of Health
LAW 8,080/1990 (HEALTH ORGANIC LAW)
Art. 4 The Unified Health System (SUS) is the set of health actions and services, rendered by federal, state and municipal public organisms and institutions, of direct and indirect Administration and the foundations maintained by the Government
Paragraph 1. The federal, state and municipal public institutions of quality control, research and production of raw materials, drugs, including blood and blood derivatives, and health equipment.
National Agency of Health Surveillance www.anvisa.gov.br Ministry of HealthMinistry of Health
LAW 8,080/1990 (HEALTH ORGANIC LAW)
Art. 6 The field of action of the Unified Health System (SUS) also includes
I – the execution of actions
a) of health surveillance; d) of whole therapeutic assistance;
VII – the control and supervision of services, products and substances of health interest;
National Agency of Health Surveillance www.anvisa.gov.br Ministry of HealthMinistry of Health
LAW 8,080/1990 (HEALTH ORGANIC LAW)
Art. 6º, § 1º Health surveillance is understood as a set of actions capable of eliminate, diminish or prevent risks to health and intervene in health problems from the environment, the production and circulation of goods e the health service rendering, including::
I – controlling consumer goods that, direct or indirectly, are related to health, including all phases and processes, from production to consumption; and
II – controlling the rendering of services that are direct or indirectly related to health.
National Agency of Health Surveillance www.anvisa.gov.br Ministry of HealthMinistry of Health
BRAZILIAN HEALTH SURVEILLANCE NATIONAL SYSTEM – SNVS
ANVISA CONASS
CONASEMS
State, Federal District and Municipal Health Surveillance Centers
LACENS INCQS/FIOCRUZ
State, Federal District and Municipal Health Councils
National Agency of Health Surveillance www.anvisa.gov.br Ministry of HealthMinistry of Health
ANVISA IN THE SUS CONTEXT Law 9,782/1999: “Art. 1 The National System
of Health Surveillance shall be responsible for the range of activities (...) carried out by the direct and indirect public administrative institutions of the Union, of the States, of the Federal District and of the Municipalities, all of which pursue activities concerned with the setting of standards and rules, together with inspection and enforcement in the area of health surveillance. (...)”
National Agency of Health Surveillance www.anvisa.gov.br Ministry of HealthMinistry of Health
ANVISA IN SUS CONTEXT ANVISA IN SUS CONTEXT LAW 9,782/1999LAW 9,782/1999
Art. 6 The institutional purpose of the agency is to promote the protection of the population’s health by exercising control over the health aspects of the production and marketing of products and services subject to health surveillance. The latter embraces premises, processes, inputs and the technologies related to the same. In addition, the Agency shall exercise health and hygiene control over ports, airports and the country’s borders.
National Agency of Health Surveillance www.anvisa.gov.br Ministry of HealthMinistry of Health
ANVISA - INSTITUTIONALANVISA - INSTITUTIONAL
MISSIONMission – “To protect and promote
health, ensuring the hygiene and safety of products and services and taking
part in developing access to it."
National Agency of Health Surveillance www.anvisa.gov.br Ministry of HealthMinistry of Health
ANVISA - INSTITUTIONALANVISA - INSTITUTIONAL
VALUES Knowledge as a springboard for
action Transparency Cooperation Accountability
National Agency of Health Surveillance www.anvisa.gov.br Ministry of HealthMinistry of Health
ANVISA - INSTITUTIONALANVISA - INSTITUTIONAL
VISION
"To be an agent for transformation of the decentralized sanitary surveillance system, within a network, holding a distinct position, legitimized by the
population, as regulator and promoter of social well-being.”
National Agency of Health Surveillance www.anvisa.gov.br Ministry of HealthMinistry of Health
National Agency of Health Surveillance www.anvisa.gov.br Ministry of HealthMinistry of Health
Extrainstitutional Interfaces
AANNVVIISSAA
AANNVVIISSAA
ProfessionalProfessionalOrganizationsOrganizationsProfessionalProfessional
OrganizationsOrganizations
Entities/Entities/AssociationsAssociations
Entities/Entities/AssociationsAssociations
WHO, PAHOWHO, PAHO UN, OASUN, OAS
WHO, PAHOWHO, PAHO UN, OASUN, OAS
CSOCSOCSOCSORegulatoryRegulatoryAgenciesAgencies
RegulatoryRegulatoryAgenciesAgencies
OfficialOfficialLaboratoriesLaboratories
OfficialOfficialLaboratoriesLaboratories
ScientificScientificCommunityCommunityScientificScientific
CommunityCommunity
RegulatedRegulatedSectorSector
RegulatedRegulatedSectorSector
CivilCivilSocietySocietyCivilCivil
SocietySociety
National Agency of Health Surveillance www.anvisa.gov.br Ministry of HealthMinistry of Health
Anvisa – Field of ActivityAnvisa – Field of Activity FoodFood CosmeticsCosmetics DrugsDrugs Health ProductsHealth Products Sanitizing ProductsSanitizing Products ToxicologyToxicology Tobacco derivativesTobacco derivatives Health ServicesHealth Services
FoodFood CosmeticsCosmetics DrugsDrugs Health ProductsHealth Products Sanitizing ProductsSanitizing Products ToxicologyToxicology Tobacco derivativesTobacco derivatives Health ServicesHealth Services
BloodBlood LaboratoriesLaboratories Economic Economic
assessment of assessment of productsproducts
Ports, airports and Ports, airports and bordersborders
Foreign RelationsForeign Relations
BloodBlood LaboratoriesLaboratories Economic Economic
assessment of assessment of productsproducts
Ports, airports and Ports, airports and bordersborders
Foreign RelationsForeign Relations
National Agency of Health Surveillance www.anvisa.gov.br Ministry of HealthMinistry of Health
ECONOMIC MARKETECONOMIC MARKET
44,500 pharmacies 22,809 registered food
companies 4,566 drug companies 3,186 cosmetics
companies 2,556 health product
companies 2,602 sanitizing product
companies
12,000 laboratories of clinical analysis
11,012 radiodiagnosis companies 5,328 hospitals 2,581 hemotherapy service units
(718 of them are public) 583 hemodialysis service units 256 nuclear medicine units 149 radiotherapy units 27 accredited Bioequivalence
Centers 155 airports, 46 ports 111 borders
National Agency of Health Surveillance www.anvisa.gov.br Ministry of HealthMinistry of Health
DrugIt is a pharmaceutical product with prophylactic, curative, palliative or diagnosis purposes .. Legal DefinitionLegal Definition
It is a crucial instrument for actions of health It is a crucial instrument for actions of health promotion, protection and recovery, promotion, protection and recovery,
involving the different levels of assistance, involving the different levels of assistance, accomplished in public and private health accomplished in public and private health
sectors.sectors.
National Agency of Health Surveillance www.anvisa.gov.br Ministry of HealthMinistry of Health
MARKET MARKET MONITORINGMONITORING
Inspection and Control Pharmacosurveillance Notification Pharmacies Sentinel Hospitals
MARKET REGULATIONMARKET REGULATION
Drug Registration Drug Registration
Price MonitoringPrice Monitoring
Clinical Research and TrialsClinical Research and Trials
Medicine product areaAnvisa’s activities
National Agency of Health Surveillance www.anvisa.gov.br Ministry of HealthMinistry of Health
DRUG HEALTH SURVEILLANCE
AUTHORIZATION FOR COMPANIES
REGISTRATIONREGISTRATION
HEALTHREGULATIONS
MONITORING AND CONTROL OF PRODUCTS IN THE
MARKET
INSPECTION OF
INSTALLATIONS
INFORMATIONINFORMATIONKNOWLEDGEKNOWLEDGE
CAPACITY-BUILDINGCAPACITY-BUILDING
National Agency of Health Surveillance www.anvisa.gov.br Ministry of HealthMinistry of Health
HEALTHHEALTH SURVEILLANCESURVEILLANCE
PRODUCTIONPRODUCTIONPHARMACEUTICALPHARMACEUTICAL
ASSISTANCEASSISTANCE
INTERLOCUTIONINTERLOCUTIONDIALOGUEDIALOGUE
INTERLOCUTIONINTERLOCUTIONDIALOGUEDIALOGUE
Safety, Efficacy, Quality Promotion of Rational Use
Acess of the Population to Essential Drugs
National Agency of Health Surveillance www.anvisa.gov.br Ministry of HealthMinistry of Health
NATIONAL POLICY ON DRUGS NATIONAL POLICY ON DRUGS DIRECTIVEDIRECTIVE
ASSURANCE OF SECURITY, EFFICACY AND QUALITY OF DRUGS
• National Health Surveillance System• Assessment• Compliance with health regulations• Inspection/Control• GMP – Inspection routes• REBLAS – to restructure for certification
National Agency of Health Surveillance www.anvisa.gov.br Ministry of HealthMinistry of Health
LAW 6,360/1976 – ASSURANCE OF DRUG QUALITY
Art 75 - The Ministry of Health shall enact norms and improve mechanisms meant to ensure consumers the quality of medicines, bearing in mind the identity, activity, purity, efficacy and innocuity of products, and encompassing quality specifications and production inspection.
National Agency of Health Surveillance www.anvisa.gov.br Ministry of HealthMinistry of Health
REGISTRATION OF DRUGS
VACCINES: responsibility of UPBIH They follow the same
recommendations for the other biological products
Legal bases: RDC 315/2005 and Law 6360/76
National Agency of Health Surveillance www.anvisa.gov.br Ministry of HealthMinistry of Health
VACCINES IN THE CONTEXT OF VACCINES IN THE CONTEXT OF HEALTH SURVEILLANCEHEALTH SURVEILLANCE
• Good Manufacturing PracticesProductionQuality Control
• Efficacy Immunogenicity
• SafetyReactogenicity/Adverse Effects
• Public Health Costs Health Economy vs. Impact on Public Health
National Agency of Health Surveillance www.anvisa.gov.br Ministry of HealthMinistry of Health
CLINICAL TRIALS
Essential to prove efficacy and safety by means of research with consumers
First step for registration Approval in research Importation for research Pre-clinical studies Clinical studies for registration purposes Phases I, II, III and IV
National Agency of Health Surveillance www.anvisa.gov.br Ministry of HealthMinistry of Health
ETHICS IN CLINICAL RESEARCH AND ETHICS IN CLINICAL RESEARCH AND QUALITY OF CLINICAL TRIALSQUALITY OF CLINICAL TRIALS
Declaration of Helsinki/Nuremberg Code Resolution 196/CNS and RDC 219/2004 “Good Clinical Practice” Governmental Policies that foster
Learning/Research and national competitiveness in the market
Greater and better participation of the Official Industry in clinical research and drug production, including vaccines
National Agency of Health Surveillance www.anvisa.gov.br Ministry of HealthMinistry of Health
ANVISA - PROGRESSANVISA - PROGRESS Emphasis on guidance related to the WHO
recommendations and international parameters
Review and updating of health framework
Implementation of public consultation
Increase in company inspection
Interaction with the regulated sector
National Agency of Health Surveillance www.anvisa.gov.br Ministry of HealthMinistry of Health
ANVISA – GOALS AND ANVISA – GOALS AND CHALLENGESCHALLENGES
To have a differentiated, population-legitimated role as an agency of regulation and
promotion of social welfare in the scope of health surveillance
National Agency of Health Surveillance www.anvisa.gov.br Ministry of HealthMinistry of Health
THANK YOU!THANK YOU! Cássio Nascimento Marques Cássio Nascimento Marques
Specialist in Health Regulation and SurveillanceSpecialist in Health Regulation and SurveillanceAgência Nacional de Vigilância SanitáriaAgência Nacional de Vigilância Sanitária
SEPN 515, Bl. B - Edifício ÔmegaSEPN 515, Bl. B - Edifício ÔmegaBrasília/DF - CEP: 70.770-502 Brasília/DF - CEP: 70.770-502
Tel: 55 (61) 3448-1000Tel: 55 (61) 3448-1000E-mail: E-mail: cassio.marques@anvisa.gov.br
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