In this review, we discuss the approval of new medicinal products, which particularly for new products containing a new active substance is increasingly done in collaboration between the European countries. This collaboration has strengthened and harmonised the scientific basis for approval of new drugs in the EU.
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Food Chem X
January 2025
Guangdong Provincial Key Laboratory of Utilization and Conservation of Food and Medicinal Resources in Northern Region, Shaoguan University, Shaoguan 512005, China.
Soil contamination with heavy metals poses a significant health risk as these metals can be transferred to humans through agricultural products. This study aimed to identify pumpkin varieties with low cadmium and arsenic accumulation. To this end, we evaluated 25 pumpkin varieties.
View Article and Find Full Text PDFDrug Des Devel Ther
January 2025
State Key Laboratory of Component-Based Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin, 301617, People's Republic of China.
Purpose: The major cardiac voltage-gated sodium channel Na1.5 (I) is essential for cardiac action potential initiation and subsequent propagation. Compound Chinese medicine Wenxin Keli (WXKL) has been shown to suppress arrhythmias and heart failure.
View Article and Find Full Text PDFJ Tradit Complement Med
January 2025
Department of Chinese Pharmaceutical Sciences and Chinese Medicine Resources, College of Chinese Medicine, China Medical University, Taichung, 40402, Taiwan.
The medicinal value of herbal products is often rooted in their "traditional" use, recontextualized by modern biomedical research granting them certain medical uses. L. (Asteraceae), native to Mexico, exemplifies such historical developments of a species that played a key role in developing a major pharmacologically active compound - lutein.
View Article and Find Full Text PDFJ Tradit Complement Med
January 2025
Immunomodulation of Natural Products Research Unit, Faculty of Allied Health Sciences, Chulalongkorn University, Bangkok 10330, Thailand.
Background And Aim: A critical causative factor of oxidative stress and inflammation leading to several skin complications is ultraviolet-B (UVB) irradiation. (LR), or tiger milk mushroom, is native to Southeast Asia. Cold water extract of an LR cultivar, TM02® (xLr®) is a promising anti-oxidant and anti-inflammatory source.
View Article and Find Full Text PDFBMJ Open
December 2024
European Medicines Agency, Amsterdam, The Netherlands
Objectives: In the European Union, a new orphan medicinal product must demonstrate 'significant benefit' over approved medicinal products targeting the same indication. To demonstrate a significant benefit, comparisons between the new product and the already approved medicinal products-either directly by a head-to-head comparison within a clinical trial or indirectly as a cross-trial comparison-are necessary. In this study, we investigate the types of trial designs and statistical approaches used for demonstrating a significant benefit of a new orphan medicinal product against approved comparators used between 2012 and 2022.
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