National Health Surveillance System (SNVS)

Transcription

1 November 19 th, 2014

2 The National Health Surveillance System 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

3 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 15 years since its creation (Law 9,782 / 1999)

4 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

5 November 19 th, 2014 Progress of alternative methods to animal testing in Brazil Joel Majerowicz, MV, MSc

6 National board of control of animal experimentation Law 11,794 - October 8 th, 2008 Decree 6,899 - july 15 th, 2009 Collegiate multidisciplinary - normative, - consultative, - deliberative and - appeal. Regulation Resolution Technical Guidelines CONCEA.html

7 Among his responsibilities include the formulation of standards for humanitarian use of animals with the purpose of teaching and scientific research, as well as establish procedures for installation and operation of centers for breeding, animal facilities and animal experimentation. Law 11,794 Art. 4º, III monitor and evaluate the introduction of alternative techniques that replace the use of animals in teaching and research;

8 National network of alternative methods 1- Stimulate the deployment of alternatives to animal testing through use of aid and technical training in the methodologies necessary; 2- Periodically monitor the performance of the associated laboratories through interlaboratory comparisons; 3- Promote the quality of trials through the development of materials for chemical and biological certified reference where applicable; 4- Encourage the implementation of laboratory quality system and the principles of good laboratory practice (GLP); 5- Promote the development, validation and certification of new alternative methods to animal use.

9 It is the first in Latin America to validate and coordinate studies of replacement, reduction and refinement of the use of animals in laboratory tests. BraCVAM and RENAMA aims to identify the laboratories and validation needs, as well as organize the studies and facilitate their implementation.

10 Laboratories Industries Universities Another National recognition

11 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

12 Next steps Identify alternative methods already accepted by regulatory agencies and recognize by Concea

13