营养药和功能食品的管理,安全和有效性评估:全球视角
Feibiao Shan1,2, Le Liu2, Ling Li2
1Inner Mongolia Traditional Chinese & Mongolian Medical Research Institute, Hohhot, China.
概括
全球对传统和补充医学 (T&CM) 的需求正在上升. 协调分散的法规和利用技术对于确保T&CM安全,有效性和国际贸易至关重要.
科学领域:
- 药理学 药理学是指药理学的学科.
- 公共卫生政策 公共卫生政策
- 监管科学 监管科学
背景情况:
- 全球对传统和补充药物 (T&CM) 的需求增加,包括营养药和功能性食品,是由健康意识和人口老龄化驱动的.
- 慢性病和预防性医疗保健趋势进一步加速了T&CM市场的增长.
- 分散的监管框架,不一致的定义和分歧的安全评估阻碍了全球贸易和消费者对T&CM的信任.
研究的目的:
- 为了比较包括中国,美国,欧盟,日本,韩国,澳大利亚,印度,俄罗斯,非洲国家和可舍/哈拉尔系统在内的全球主要地区的T&CM治理.
- 在这些不同的监管环境中分析立法里程碑和风险管理模型.
- 确定标准化,成分批准流程和T&CM的证据要求中的关键差异.
主要方法:
- 对T&CM在选定的国家和地区的立法框架和监管政策进行比较分析.
- 审查在T&CM治理中使用的风险管理策略和安全评估系统.
- 探索新兴技术,如人工智能,多omics和区块链,用于T&CM质量控制和可追溯性.
主要成果:
- 在全球范围内,在T&CM标准化,成分批准和证据要求方面存在重大差异.
- 亚洲和西方国家通常有强有力的T&CM法规,而非洲国家面临着将传统做法与现代安全标准相结合的挑战.
- 新兴技术为提高T&CM安全性,有效性和可追溯性提供了潜在的解决方案.
结论:
- 迫切需要为T&CM制定国际协调的监管框架,以促进全球贸易并确保消费者安全.
- 将传统知识与科学验证相结合,得到明确的成分清单和跨境合作的支持,可以优化市场准入.
- 这项研究为决策者提供了可行的见解,以促进全球健康行业的公平贸易和创新,将文化遗产与公共卫生联系起来.
更多相关视频
10:18Author Spotlight: Exploring Seaweed's Bioactive Compounds for Sustainable Innovations in Industries
Published on: November 21, 2023
2.8K
07:36Analysis of Raw and Processed Cyperi Rhizoma Samples Using Liquid Chromatography-Tandem Mass Spectrometry in Rats with Primary Dysmenorrhea
Published on: December 23, 2022
1.6K
相关概念视频
01:25Drug 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
01:19Pharmacovigilance
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
01:03Drug 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
01:29Assessment of the Gastrointestinal System II: Health Perception Pattern
164
Assessing the gastrointestinal (GI) system is a complex process that begins with collecting subjective data. This data, collected through patient interviews, provides crucial insights into the patient's health history, perception patterns, and lifestyle habits, all contributing significantly to GI health.
Health Perception Patterns
Health perception patterns offer valuable insights into a patient's lifestyle habits and how they may impact their GI health. These patterns include:
Health Perception Patterns
Health perception patterns offer valuable insights into a patient's lifestyle habits and how they may impact their GI health. These patterns include:
164
01:28Preclinical Development: Overview
4.9K
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...
4.9K
01:11Clinical Trials: Overview
3.4K
Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
3.4K