Introduction to the Inspection of Quality and Technical Documents for the Registration of Veterinary Chemical Drugs
Chi-Ho, Liu
Abstract
The Animal Drugs Inspection Branch is responsible for the national inspection of veterinary drugs. In addition to laboratory inspection work, it also conducts the document inspection of Quality Technical Documents (QTD) for veterinary drug registration. This presentation provides an overview of the inspection process for QTDs in the registration of veterinary chemical drugs, covering the scope of QTDs, regulatory basis, review methods, review statistics, common deficiencies, and case studies.
First, the presentation introduces the scope of QTDs and the regulations governing the review process. It provides an overview of the current regulatory framework for veterinary drug registration in the country, including government regulations and international standards. Next, it explains the review methods and key points of assessment, along with the logical approach applied in the review process.
The review statistics section presents data on QTD inspection in recent years, including the number of cases reviewed, requests for supplementary documents, and common deficiencies encountered. This serves as a reference for the industry.
Finally, the document discusses common deficiencies and case studies, highlighting frequent issues encountered during the application process, such as incomplete documentation, insufficient test data, and misapplication of regulations. It also provides specific case examples and improvement recommendations to facilitate a more efficient inspection process.
High-profile veterinary forensic pathology case analysis
Yen-Wen Chen
Abstract
This study presents the analysis of two high-profile animal mortality cases investigated by the Veterinary Research Institute: (1) The " Winter Mortality Events in Yangmingshan Water Buffaloes" (late 2020 to early 2021): Postmortem examinations revealed that the diseased water buffaloes (Bubalus bubalis) exhibited chronic malnutrition, hypoproteinemia, systemic serous fat atrophy, and bone marrow hypoplasia. These findings suggested that limited foraging resources and extreme weather changes could be the contributing factors; (2) The "Gunshot Injury in an Olive Baboon" (2023): A free-ranging olive baboon (Papio anubis) was found in Yangmei District, Taoyuan City. During the capture process, the baboon sustained a perforating gunshot lethal wound to the thoracic cavity and heart, inflicted by a non-contact or non-close-range shot. Forensic examination revealed corresponding gunshot evidence at the entry and exit wounds.
Both cases required rapid information integration and multidisciplinary collaboration due to their high-profile nature and public scrutiny. By applying diagnostic techniques from veterinary pathology, forensic pathology, toxicology, and molecular diagnostics, the causes and manners of death were elucidated systematically. These findings provided robust scientific evidence for judicial proceedings, contributed to the promotion of animal welfare, and supported improvements in wildlife conservation and management frameworks.