加拿大先进药品监管的现行做法与改革建议

Current practices and reform proposals for the regulation of advanced medicinal products in Canada.

作者信息

Viswanathan Sowmya, Bubela Tania

机构信息

Cell Therapy Program, University Health Network, Toronto, ON, Canada.

Institute of Biomaterials & Biomedical Engineering, University of Toronto, Toronto, ON, Canada.

出版信息

Regen Med. 2015;10(5):647-63. doi: 10.2217/rme.15.28.

DOI:10.2217/rme.15.28

PMID:26237706

Abstract

We describe the Canadian regulatory framework for evaluating advanced medicinal products based on current policies, guidance documents and regulations and analyze proposed reforms. Our analysis is based on a documentary review supplemented by discussions with Health Canada officials. We present an overview of the Canadian regulatory framework for cell and gene therapy, medical devices and manufacturing facilities. We use the approval of Prochymal™ to highlight Canada's conditional marketing approval system. Finally, we discuss proposed changes to the regulatory framework in response to identified gaps, stakeholder consultations and international harmonization initiatives. Based on our analyses, we suggest that Canadian regulators have taken a reasonable approach in applying their regulatory framework without compromising on product safety.

摘要

我们根据现行政策、指导文件和法规描述了加拿大评估先进医药产品的监管框架，并分析了拟议的改革。我们的分析基于文献综述，并辅以与加拿大卫生部官员的讨论。我们概述了加拿大细胞和基因疗法、医疗器械及生产设施的监管框架。我们以Prochymal™的获批为例，突出加拿大的有条件市场批准制度。最后，我们讨论了针对已发现的差距、利益相关方磋商及国际协调倡议对监管框架提出的拟议变更。基于我们的分析，我们认为加拿大监管机构在应用其监管框架时采取了合理的方法，且未在产品安全方面妥协。