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

Country/Territory
Indonesia
Document type
Regulation
Date
2022
Source
FAO, FAOLEX
Original source
State Gazette of the Republic of Indonesia no. 490 of 2022.
Subject
Food & nutrition
Keyword
Food quality control/food safety Hygiene/sanitary procedures Public health Toxicity/poisoning Treated food
Geographical area
Asia, Asia and the Pacific, East Asian Seas, Indian Ocean, South-Eastern Asia
Abstract

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.

Full text
Indonesian
Website
peraturan.bpk.go.id

References - Legislation

Implements

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

Legislation | Indonesia | 2017

Keyword: Food security, Authorization/permit, Food additives, Food quality control/food safety, Governance, Inspection, Public health, Standards, Treated food

Source: FAO, FAOLEX