Aquaculture drug efficacy trial guidelines have been released for industry comment by China’s China Institute of Veterinary Drug Control.
The draft technical guidelines cover the research and development of aquaculture drugs, by strengthening the technical guidance of clinical trial studies. In total there are five (5) technical guidelines for efficacy trials of antibacterial drugs, anthelmintic drugs and disinfectants.
The overall design principles should follow the provisions of the Good Clinical Practice (GCP) for Veterinary Drug Trials.
Here is the key information of these five guidelines:
1. Technical Guidelines for Aquaculture Antibacterial Drug Efficacy Trials
The efficacy trials of antimicrobial drugs for aquaculture are used to evaluate the effectiveness of antimicrobial drugs in preventing and controlling the target indications in aquaculture animals and to detect possible adverse reactions, in order to determine the effectiveness of the drugs and the dosing regimen.
This guideline is applicable to the efficacy trials of antimicrobial drugs for aquaculture, and represents only the current general understanding of the efficacy trial studies of antimicrobial drugs for aquaculture, aiming to provide technical guidance and reference for the development, implementation and supervision of efficacy clinical trial protocols for researchers of efficacy trials of antimicrobial drugs for aquaculture and applicants for registration of pharmaceutical products.
2. Technical Guidelines for Field Efficacy Trials of Antibacterial Drugs in Aquaculture
The field efficacy test of antimicrobial drugs for aquaculture is used to further verify the effectiveness and safety of antimicrobial drugs for aquaculture on the target indications of target animals under actual production conditions.
The field efficacy test should be conducted on the basis of the results of the efficacy test of antimicrobial drugs for aquaculture, with reference to the test program of the efficacy test of antimicrobial drugs for aquaculture, and in combination with the actual breeding conditions, environmental conditions and medical conditions, and other comprehensive considerations.
3. Technical guidelines for Efficacy Trials of anthelmintic (insecticidal) drugs used in aquaculture
Efficacy trials of deworming (insecticidal) drugs for aquaculture are used to evaluate the effectiveness of deworming (insecticidal) drugs for the control of target indications in aquaculture animals and to detect possible adverse reactions, in order to determine the effectiveness of the drug and the dosing regimen.
This guideline applies to the efficacy test of insecticidal drugs for aquaculture, and represents only the current general understanding of the efficacy test of insecticidal drugs for aquaculture, and is intended to provide technical guidance for researchers of efficacy test of insecticidal drugs for aquaculture and applicants for registration of drugs for the development, implementation and supervision of efficacy clinical trial protocols.
4. Technical Guidelines for Field Efficacy Trials of Parasiticides for Aquaculture
Field efficacy test of deworming (insecticidal) drugs for aquaculture is used to further verify the effectiveness and safety of deworming (insecticidal) drugs for aquaculture on the target indications of target animals under actual production conditions.
The field efficacy test should be conducted on the basis of the results of the efficacy test of the insecticidal drug for aquaculture, with reference to the test program of the efficacy test of the insecticidal drug for aquaculture, and taking into account the actual breeding conditions, environmental conditions and disease conditions.
5. Technical Guidelines for Efficacy Trial of Disinfectants for Aquaculture
The efficacy test of disinfectants for aquaculture is used to evaluate the efficacy of disinfectants for aquaculture in disinfecting the external environment, tools and facilities of aquatic animals and/or in preventing and controlling the target indications of aquatic animals, in order to determine the efficacy of the disinfectants and the rational use plan, and to find out the possible adverse reactions.
This guideline is applicable to the efficacy test of disinfectants for aquaculture (including disinfection effect test and prevention and control effect test of target indications), which only represents the general understanding of the current study on the efficacy test of disinfectants for aquaculture, and is intended to provide technical guidance and reference for the researchers of efficacy test of disinfectants for aquaculture and the applicants for drug registration to formulate, implement and supervise the efficacy clinical trial program.
How to submit comments
Please send your suggestions, comments and feedback directly to hypszx2020@163.com before February 15, 2024.
Further information
Read the original announcement on Aquaculture drug efficacy trial guidelines – draft for comments.
