The National Health Surveillance System. March 31 st Agência Nacional de Vigilância Sanitária

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1 The National Health Surveillance System Agência Nacional de Vigilância Sanitária March 31 st

2 ANVISA Mission: To promote and protect the population health and to act on the risks that arrives from the production and use of products and services subject to health surveillance, acting coordinated with states and municipalities, following the Unified Health Systems (SUS) principles, to improve Brazilian population life quality Vision: To be legitimated by the society as an institution that is part of the SUS, expedite, modern and transparent, national and international reference on health regulation and control. Values: Ethics and responsibility as a public agent Capacity of articulation and integration Excellence in management Science based decision Transparency Accountability Agência Nacional de Vigilância Sanitária

3 National Health Surveillance System (SNVS) Integrates the Unified Health System (SUS) Integrated by the Federal, State and Local level Coordinated by Anvisa Characteristic: articulation and decentralization Population: Area: 8,514,876 Km 2 27 Federative States 5,560 Municipalities Federal Ministry of Health ANVISA National Institute for Quality Control in Health State Level State Secretary of Healht State Health Surveillance Laboratories of Public Health - LACEN Municipal Level Local Secretary of Health Local Health Surveillance

4 The Brazilian Health Surveillance Agency (Anvisa) Regulatory Agency: Administrative Independence and finance autonomy Linked to the Ministry of Health Management Contract (indicators and targets) Stability of the Directors (mandate) Collegiate Board 5 Directors named by the President of Republic, after approval by the federal senate mandate of 3 years, renewed for 3 extra years. Science-based technical decisions Predictability and transparency of the regulatory process 16 years since its creation (Law 9,782 / 1999)

5 Areas of action Food Cosmetics Sanitizing Products Drugs Toxicology (pesticides) Health services Tobacco Medical Devices Laboratories Blood, Cell, Tissues and Organs Post-marketing surveillance Marketing control Ports, airports and frontiers International Market regulation

6 Industries Universities Laboratories Another National recognition

7 Alternative methods proposed by CONCEA submitted for ANVISA's acceptance. OECD GD 129 Guindance Document on Using Cytotoxicity Test to Estimate Starting Doses for Acute Oral Systemic Toxicity Test OECD TG Acute Oral Toxicity Fixed Dose Procedure OECD TG Acute Oral Toxicity Acute Toxic Class Method OECD TG Acute Oral Toxicity Up-and-Down-Procedure (UDP) OECD TG Skin Absorption: in vitro Method OECD TG Skin Sensitization: Local Lymph Node Assay OECD TG In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test Method (TER) OECD TG In vitro skin corrosion: reconstructed human epidermis (RHE) test method OECD TG In vitro 3T3 NRU phototoxicity test OECD TG In Vitro Membrane Barrier Test Method for Skin Corrosion OECD TG Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage OECD TG Isolated Chicken Eye Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage OECD TG In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method OECD TG 422A - Skin Sensitization: Local Lymph Node Assay: DA OEDC TG 422B - Skin Sensitization: Local Lymph Node Assay: BrdU-ELISA OECD TG Fluorescein Leakage Test Method for Identifying Ocular Corrosives and Severe Irritants OECD TG In Vitro Mammalian Cell Micronucleus Test

8 OECD TG 431 OECD TG 435 OECD TG 439 OECD TG 437 OECD TG 438 OECD TG 460 OECD TG 432 OECD TG 428 OECD TG 429 OECD TG 442A e 442B OECD TG 420 OECD TG 423 OECD TG 425 OECD GD 129 OECD TG 487 Agência Nacional de Vigilância Sanitária Anvisa 4,5 4 3,5 3 2,5 2 1,5 1 0,5 0 Aceito accepted sem without restrição restriction Aceito accepted com with restrição restrictions Sem not accepted aceitação pela área

9 TOXICOLOGY - should be considered the limitations described in the OECD protocol, so that other studies may be needed. FOOD -... despite being a widely used method... trials to evaluate the genotoxicity potential of a substance can not be restricted to OECD TG 487. COSMETICS - With supplementary testing of the finished product in use (in humans) DRUGS - limitations described in the OECD document MEDICAL devices and CLINICAL RESEARCH and FOOD - The test has applicability limitations as described in the OECD protocol,...

10 Agência The Nacional National Health de Vigilância Surveillance Sanitária System Anvisa MEDICAL DEVICE OFFICE - OECD GD Being draft, and unclassified, doubt if it is approved and recognized as technical standard. If this is approved and recognized as technical standard, it will be accept with restriction.

11 Agência The Nacional National Health de Vigilância Surveillance Sanitária System Anvisa aceito Não Aceito Toxicologia Alimentos Cosméticos Medicamentos Produtos para Saúde Pesquisa Clínica correlatos e alimentos Toxicology Food Cosmetics Drugs Medical Devices Health Services

12 Agência The Nacional National Health de Vigilância Surveillance Sanitária System Anvisa Next steps Identify alternative methods already accepted by regulatory agencies and recognize by Concea

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