为兽药监管机构开发一种自我评估/基准评价工具
Noel Joseph1, S Peter Borriello2, Suzanne Eckford1
1International Office, Veterinary Medicines Directorate, Department for the Environment, Food and Rural Affairs, Surrey, United Kingdom.
Frontiers in veterinary science
|October 9, 2025
概括
建议为兽医监管机构提供一个新的基准测试工具,以提高全球标准. 该倡议旨在提高监管能力,确保为动物和人类提供更安全的药物.
科学领域:
- 兽医药理学和毒理学 兽医药理学和毒理学
- 监管科学 监管科学
- 公共卫生 公共卫生
背景情况:
- 对兽医药物的有效监管对于动物福利,人类健康,食品安全和环境保护至关重要.
- 目前的监管系统缺乏全面的全球基准测试工具,与世界卫生组织 (WHO) 对人类药物的建立方案不同.
- 这种差距阻碍了全球兽医监管能力的系统评估和加强.
研究的目的:
- 为了解决兽药监管机构缺乏全球,全面的基准测试计划的问题.
- 提出一个新的工具来评估和加强兽医部门的监管能力.
- 促进协调,并确保全球兽医药品的质量,安全性和有效性.
主要方法:
- 对现有的兽药监管制度进行了系统审查.
- 这些方案与世卫组织的人类药物全球基准测试工具进行了比较.
- 基于这一比较分析,为兽医监管机构量身定制的全新综合计划提出了建议.
主要成果:
- 审查发现,对于兽医法规而言,一个全球公认的,全面的基准评估工具显著缺乏.
- 对比分析强调了与人用药物监管框架相比的关键差异和潜在改进领域.
- 制定了一项拟议方案,为评估和加强监管系统提供了一种系统的方法.
结论:
- 开发专门的全球基准测试工具对于兽医监管部门至关重要.
- 该工具将为评估和改善监管能力提供一个系统的框架.
- 实施此类计划将加强协调,建立利益相关者的信心,并确保兽药的质量,安全性和有效性.
相关概念视频
01:25Drug Regulation
2.7K
Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
2.7K
01:19Pharmacovigilance
1.6K
Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
1.6K
01:29Clinically Relevant Drug Product Specifications: Methods of Establishment
203
Product specifications define the acceptable quality of a pharmaceutical product by ensuring identity, purity, potency, and strength. These specifications serve as benchmarks during development, manufacturing, and post-approval quality control. Clinically relevant specifications are particularly important because they directly relate to a drug's safety and efficacy in clinical use.Dissolution studies are critical biopharmaceutic tools that link in vitro behavior to in vivo performance. They...
203
01:28Drug Products: Biologics, Biosimilars and Interchangeables
233
Body:Biologics, derived from living sources such as humans, animals, or microorganisms, represent a significant category of pharmaceuticals. These complex molecules, developed through advanced biotechnological methods or purified from natural sources, include essential medical treatments like insulin and growth hormones. The complexity of biologics arises from their large molecular structures and the intricate processes required for their production, making them distinct from conventional...
233
01:28Preclinical Development: Overview
5.8K
Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
5.8K
01:10In Vitro Drug Release Testing: Overview, Development and Validation
305
In vitro dissolution and drug release tests assess how quickly and how much of a drug is released from its dosage form into an aqueous medium under standardized laboratory conditions. These tests are essential tools in pharmaceutical development and quality assurance, offering insight into the drug's performance before clinical use.During formulation development, dissolution testing identifies incomplete or inconsistent drug release issues. It also supports decisions on selecting the optimal...
305