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首页> 外文期刊>The Canadian Journal of Neurological Sciences: le Journal Canadien des Sciences Neurologiques >Canadian drug regulatory framework.
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Canadian drug regulatory framework.

机译：加拿大药品监管框架。

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摘要

The role of regulatory drug submission evaluators in Canada is to critically assess both the data submitted and the sponsor's interpretation of the data in order to reach an evidence-, and context-based recommendation as to the potential benefits and potential harms (i.e., risks) associated with taking the drug under the proposed conditions of use. The purpose of this document is to outline the regulatory framework in which this assessment occurs, including: defining what "authorization to market a drug in Canada" means, in terms of the role of the sponsor, the responsibility of Health Canada in applying the Food and Drugs Act prior to and after marketing authorization, and the distinction between regulatory authorization versus physician authorization; highlighting organizational, process and legal factors within Health Canada related to authorization of clinical trials and authorization to market a drug; considerations during the review process, such as regulatory and scientific issues related to thedrug, patient populations and trial designs; application of international guidelines, and decisions from other jurisdictions; regulatory realities regarding drug authorization, including the requirement for wording in the Product Monograph to accurately reflect the information currently available on the safe and effective use of a drug, and that hypothesis-confirming studies are essential to regulatory endorsement; current issues related to the review of therapies for dementia, such as assessing preventative treatments, and therapies that have symptomatic versus disease-modifying effects, statistical issues regarding missing data, and trial design issues.
机译：在加拿大，监管药物提交评估者的作用是严格评估提交的数据和申办者对数据的解释，以便就潜在的利益和潜在的危害（即风险）达成基于证据和基于上下文的建议与在建议的使用条件下服用药物有关。本文档旨在概述进行此评估的法规框架，包括：定义“授权在加拿大销售药品”，就保荐人的作用而言，意味着加拿大卫生部在应用食品方面的责任。以及上市授权前后的《药品法》，以及监管授权与医师授权之间的区别;强调加拿大卫生部内与临床试验授权和药品销售授权有关的组织，程序和法律因素;审查过程中的考虑因素，例如与药物，患者人群和试验设计有关的法规和科学问题;适用国际准则以及其他司法管辖区的决定;有关药物授权的监管现实，包括《产品专论》中的措词要求，以准确反映当前有关安全有效使用药物的信息，并且假设确认研究对监管认可至关重要;与痴呆症治疗的审查有关的当前问题，例如评估预防性治疗以及具有症状对疾病缓解作用的治疗，有关数据丢失的统计问题以及试验设计问题。

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