在选定的国家中对COVID-19疫苗的授权途径进行范围审查
Supapitch Suphap1,2, Parnnaphat Luksameesate3, Osot Nerapusee4
1Medicines Regulation Division, Thailand Food and Drug Administration, Ministry of Public Health, Nonthaburi, Thailand.
Journal of pharmaceutical policy and practice
|July 4, 2025
概括
全球监管机构通过紧急使用授权 (EUA) 和有条件营销授权 (CMA) 加快了COVID-19疫苗的批准. 国际合作大大缩短了审查时间,提高了全球流行病的准备.
科学领域:
- 监管科学是一种监管科学.
- 全球卫生政策 全球卫生政策
- 药品监管法规 药品监管法规 药品监管法规
背景情况:
- 由于COVID-19大流行,监管机构需要迅速授权疫苗.
- 实施了紧急使用授权 (EUA) 和有条件营销授权 (CMA) 等加速机制.
- 现有的有限研究强调需要对全球疫苗批准途径进行全面审查.
研究的目的:
- 在不同国家探索多样化的COVID-19疫苗批准途径.
- 调查用于支持和加速疫苗授权的战略.
- 分析COVID-19疫苗批准审查时间表.
主要方法:
- 进行了范围审查,重点关注具有严格监管机构或大量疫苗制造/推广的国家.
- 搜索包括在数据库和监管机构网站上搜索"批准程序"和"COVID-19疫苗"等术语.
- 数据的提取和分析涉及授权流程,支持策略和时间表的内容和比较监管分析.
主要成果:
- 来自20个国家的24条监管途径被确定 (10个欧元,8个CMA,6个TA).
- 共同的要求包括良好的制造实践 (92%),利益风险评估 (86%) 和未满足需求 (83%).
- 像滚动提交 (85%) 和提交前会议 (85%) 这样的加快策略是普遍存在的;审查时间比标准快3-27倍.
结论:
- 尽管有不同的途径,但在全球范围内,最初的COVID-19疫苗批准速度很快.
- 国际合作对于加速疫苗授权流程至关重要.
- 流行病的经验对全球对未来健康危机的准备有积极的影响.
相关概念视频
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
180
Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
180
Vaccinations
45.3K
Overview
45.3K
Drug Control Governance: Regulatory Bodies and Their Impact
255
Drug control governance involves the oversight and regulation of pharmaceuticals to ensure their safety and efficacy while preventing illegal drug use and trafficking. Regulatory bodies, including the US Food and Drug Administration (FDA) and the European Union's European Medicines Agency (EMA), play a central role in this process. These agencies evaluate the safety and efficacy of drugs before they can be marketed. They fund clinical trials and assess the benefits and risks associated with...
255
Pharmacovigilance
999
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...
999
Drug Administration and Therapy Phases: Overview
766
Drugs, the chemical agents used in diagnosing, treating, or preventing diseases, undergo a four-phase process of development: pharmaceutic, pharmacokinetics, pharmacodynamics, and therapeutic.
The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
The pharmacokinetic phase...
The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
The pharmacokinetic phase...
766
Drug Regulation
1.9K
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...
1.9K


