中国孤儿药评价制度的改革

IF 2.7 4区医学 Q2 PHARMACOLOGY & PHARMACY Journal of Pharmaceutical Innovation Pub Date : 2021-05-21 DOI:10.1007/s12247-021-09560-7

Xiangyu Wang, Lin Wang, Xiaoying Zheng, Qiang Zheng

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引用次数: 1

摘要

这篇透视文章提供了中国罕见病和孤儿药监管的历史背景和当前思考，并在快速发展的中国所特有的看似错综复杂的政府机构和监管政策的背景下，展示了正在进行的孤儿药评估制度改革。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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The Reform of the Orphan Drug Assessment System in China

This perspective article provides historical background and current considerations of the regulation of rare diseases and orphan drugs in China, presenting the ongoing reform of the orphan drug assessment system in the context of a maze of seemingly convoluted government agencies and regulatory policies that are unique to the fast developing China.

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来源期刊

Journal of Pharmaceutical Innovation PHARMACOLOGY & PHARMACY-

CiteScore

3.70

自引率

3.80%

发文量

审稿时长

>12 weeks

期刊介绍： The Journal of Pharmaceutical Innovation (JPI), is an international, multidisciplinary peer-reviewed scientific journal dedicated to publishing high quality papers emphasizing innovative research and applied technologies within the pharmaceutical and biotechnology industries. JPI''s goal is to be the premier communication vehicle for the critical body of knowledge that is needed for scientific evolution and technical innovation, from R&D to market. Topics will fall under the following categories: Materials science, Product design, Process design, optimization, automation and control, Facilities; Information management, Regulatory policy and strategy, Supply chain developments , Education and professional development, Journal of Pharmaceutical Innovation publishes four issues a year.