弥合差距:通过比较分析在非洲环境中增强血液调节功能
Washington T Samukange1,2,3, Verena Kluempers1, Chancelar Kafere1
1Centre for International Cooperation, Paul-Ehrlich-Institut, Langen, Germany.
Frontiers in medicine
|May 16, 2025
概括
非洲国家监管机构 (NRA) 在授权血液制品方面表现更强,而不是在批准血分离过程方面. 优先考虑全球基准测试工具 (GBT) +血液对于加强监管能力和确保获得安全血液制品至关重要.
科学领域:
- 监管科学 监管科学
- 公共卫生 公共卫生
- 血液产品安全 血液产品安全
背景情况:
- 血液调节系统的独立评估对于改善获得安全血液,血液成分和产品的机会至关重要.
- 世界卫生组织的全球基准测试工具 (GBT) 加上血液有助于制定国家监管机构 (NRA).
研究的目的:
- 评估和比较非洲国家对血液,血液成分和血分离的注册,营销许可和批准的监管职能的实施和执行情况.
- 使用GBT加血工具评估监管系统的有效性.
主要方法:
- 在12个非洲国家使用GBT加血液工具进行了辅助自我基准测试.
- 该研究评估了34个用于注册和营销许可功能的子指标和24个用于批准血液,血液成分和血的分离功能的子指标.
- 在世界卫生组织指定的成熟度3级 (ML3) 国家监管机构和非指定的国家监管机构之间进行了比较评估.
主要成果:
- 注册和营销许可功能的实施得分较高 (平均73%) 与血液,血液组件和血的分成功能 (平均45%) 的批准相比.
- 被ML3指定的NRA在注册和营销许可方面表现明显更高 (91%) 比未被指定的NRA (71%).
- 在批准血液,血液成分和血用于分化功能方面,ML3指定和非指定NRA之间的性能差异是最小的.
结论:
- 大多数国家监管机构在授权血衍生物药物方面表现良好,但在调节血液,血液成分和血分成过程方面表现出显著的弱点.
- 在被评估的非洲国家,血液和血液制品的监管框架在很大程度上是新生的.
- 迫切需要使用GBT加血液对NRA进行正式的基准测试,以加强非洲血液和血液制品的监管能力.
更多相关视频
相关概念视频
Blood Transfusion
443
Blood transfusion is a critical medical procedure that saves lives and treats various medical conditions. It involves transferring blood from a donor to a recipient. This process requires a thorough understanding of the ABO blood group system and its associated antigens and antibodies.
Blood Transfusion Overview
A blood transfusion is a medical procedure used to replace blood lost due to injury, surgery, or to treat conditions such as anemia or cancer. During a transfusion, donor blood is...
Blood Transfusion Overview
A blood transfusion is a medical procedure used to replace blood lost due to injury, surgery, or to treat conditions such as anemia or cancer. During a transfusion, donor blood is...
443
Hormonal Regulation
32.8K
The renin-aldosterone system is an endocrine system which guides the renal absorption of water and electrolytes, thus managing blood pressure and osmoregulation. Activation of the system begins in the kidneys with a small cluster of cells adjacent to the afferent and efferent blood vessels of the renal corpuscle. As the nephrons are filtering blood, juxtaglomerular cells monitor blood pressure. If they detect a decrease in pressure, they release the hormone renin into the bloodstream.
32.8K
Hormonal Regulation of Blood Pressure
2.3K
Endocrinal or hormonal intervention in the cardiovascular system is predominantly exerted by the catecholamines - epinephrine and norepinephrine, as well as a slew of hormones that interact with renal function to modulate blood volume.
Epinephrine and Norepinephrine
The adrenal medulla releases epinephrine and norepinephrine, catecholamines that enhance and extend the sympathetic or "fight or flight" physiological response. These hormones escalate heart rate and the force of contraction...
Epinephrine and Norepinephrine
The adrenal medulla releases epinephrine and norepinephrine, catecholamines that enhance and extend the sympathetic or "fight or flight" physiological response. These hormones escalate heart rate and the force of contraction...
2.3K
Blood Studies I: ABG and VBG
433
Blood studies are critical in the medical field, enabling healthcare professionals to assess a patient's health status accurately. This page will focus on two significant blood studies: Arterial Blood Gas (ABG) and Venous Blood Gas (VBG).
Arterial Blood Gas (ABG)
Arterial Blood Gas (ABG) studies are crucial for assessing the lungs' ability to supply oxygen and remove carbon dioxide, reflecting the patient's ventilation status. They also help understand the kidneys' capacity to...
Arterial Blood Gas (ABG)
Arterial Blood Gas (ABG) studies are crucial for assessing the lungs' ability to supply oxygen and remove carbon dioxide, reflecting the patient's ventilation status. They also help understand the kidneys' capacity to...
433
Factors affecting Blood pressure
2.8K
Several physiological and lifestyle factors influence blood pressure (BP). Understanding these factors is crucial as they are significant in patient education and blood pressure management.
Physiological Factors:
Physiological Factors:
2.8K
Role of Hematopoietic Growth Factors
1.2K
Hematopoietic growth factors are molecules that regulate the differentiation rate of hematopoietic stem cells (HSCs). Erythropoietin (EPO), primarily produced by the kidneys, plays a crucial role in erythrocyte production. When oxygen levels in the blood are low, EPO is released into the bloodstream, reaching the bone marrow, where it stimulates HSCs to differentiate and mature into erythrocytes, which are vital for oxygen transport.
Thrombopoietin (TPO), mainly released by the liver,...
Thrombopoietin (TPO), mainly released by the liver,...
1.2K


