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Regulation of the Food and Drug Supervisory Agency no. 10 of 2022 concerning Guidelines for In Vivo Preclinical Toxicity Testing.

País/Territorio
Indonesia
Tipo de documento
Reglamento
Fecha
2022
Fuente
FAO, FAOLEX
Fuente original
State Gazette of the Republic of Indonesia no. 490 of 2022.
Materia
Alimentación y nutrición
Palabra clave
Control de calidad de los alimentos/inocuidad de los alimentos Higiene/procedimientos sanitarios Salud pública Toxicidad/envenenamiento Alimentos tratados
Área geográphica
Asia, Asia y Pacifico, Mares del Asia Oriental, Océano Índico, Asia Sudoriental
Resumen

This Regulation, based on the provisions of article 3 paragraph (1) letter d of the Presidential Regulation no. 80 of 2017 concerning the functions of the Food and Drug Supervisor Agency, provides for defining guidelines and procedures for preclinical toxicity tests in vivo, in order to study the cumulative effects of substances that may have adverse or toxic effects on humans, and to guarantee the safety of exposure to a substance in humans. The Regulation defines: preclinical toxicity test carried out on animals; medicines for human health promotion, recovery and healing; cosmetics. The Regulation concerns tests conducted on the following products: drugs, medicines, traditional medicines, cosmetics, processed food; procedure for submitting approval for test implementation; guidelines and indicators for conducting tests; types of toxicity tests.

Texto completo
Indonesio
Página web
peraturan.bpk.go.id

Referencias - Legislación

Implementa

Presidential Regulation Number 80 of 2017 concerning the Drug and Food Control Agency.

Legislación | Indonesia | 2017

Palabra clave: Seguridad alimentaria, Autorización/permiso, Aditivos alimentarios, Control de calidad de los alimentos/inocuidad de los alimentos, Gobernanza, Inspección, Salud pública, Normas, Alimentos tratados

Fuente: FAO, FAOLEX