CO 026: ALTERNATIVE METHODS AND THE SAFETY ASSESSMENT OF HEALTH PRODUCTS: EXPERIENCE OF NATIONAL INSTITUTE OF QUALITY CONTROL IN HEALTH, BRAZIL

J Pharm Pharmacogn Res 2(Suppl. 1): S14, 2014

Special supplement with the abstract book of LATINFARMA 2013

Oral Communication

CO 026: ALTERNATIVE METHODS AND THE SAFETY ASSESSMENT OF HEALTH PRODUCTS: EXPERIENCE OF NATIONAL INSTITUTE OF QUALITY CONTROL IN HEALTH, BRAZIL

Fernandes Delgado I, Chaves Leal E.

National Institute of Quality Control in Health (INCQS) – Oswaldo Cruz Foundation (Fiocruz) – Av. Brasil, 4365 – Manguinhos – Rio de Janeiro – Brasil. www.incqs.fiocruz.br – E-mail: isabella.delgado@incqs.fiocruz.br
Abstract

The National Institute of Quality Control in Health (INCQS) is a technical-scientific unit of the Oswaldo Cruz Foundation (Fiocruz) and is the Brazilian Reference Laboratory which handles the quality control of food, drugs, biological products, health-related and dialysis items, hygienizing and disinfectant agents, diagnostic kits, cosmetics, blood and blood derivatives, environments and services. Its mission is to contribute to the promotion and recovery of health conditions, to the prevention of diseases, acting as the National Reference for scientific and technical issues regarding the quality control of products, environments and health services. Regarding safety assessment, our staff has been dealing with toxicological assays and also works to develop, adjust and implement new methodologies. In the field of alternative methods, some new approaches have been investigated, such as: (i.) alternatives to eye and skin irritation tests, including HETCAM, RBC and cytotoxicity assays, (ii.) alternatives to pyrogen test and (iii.) phototoxicity, as well as (iv.) in silico alternatives. Additionally, our staff has been working in strait collaboration with Brazilian Health Surveillance Agency (Anvisa) in order to consolidate activities of the newly created Brazilian Center for Validation of Alternative Methods (BraCVAM). By means of this initiative, it is aimed to achieve interlaboratory validation of alternative methodologies, seeking the regulatory acceptance.