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Administrative measures for the research and development of new veterinary drugs.

Country/Territory
China
Document type
Regulation
Date
2005
Source
FAO, FAOLEX
Subject
Livestock
Keyword
Animal health Drugs Inspection Research Offences/penalties
Geographical area
Asia, Asia and the Pacific, East Asian Seas, Eastern Asia, North Pacific, North-West Pacific
Abstract

These Measures, consisting of 30 Articles, aim to ensure the safety, effectiveness and quality of the veterinary drugs, and regulate the development activities of the veterinary drugs. The Measures consist of 5 Chapers: General provisions; Preclinical research management; Clinical trial approval; Supervision and administration; Penalties. The safety asssesment shall be carried out for the development of new veterinary drugs.The unit that undertakes the safety evaluation of the new veterinary drugs shall have the qualification to be recognized by the Ministry of Agriculture, follow the quality control guidelines for the veterinary drug non-clinical research, and refer to the relevant technical guiding principles issued by the Ministry of Agriculture to carry out the experiment.

Full text
Chinese
Website
www.law-lib.com