Article(id=1322626729902981170, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322626690153562922, articleNumber=null, orderNo=null, doi=null, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=null, receivedDateStr=null, revisedDate=null, revisedDateStr=null, acceptedDate=1601827200000, acceptedDateStr=2020-10-05, onlineDate=1793268385625, onlineDateStr=2026-10-29, pubDate=1610640000000, pubDateStr=2021-01-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793268385625, onlineIssueDateStr=2026-10-29, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793268385625, creator=13701087609, updateTime=1793268385625, updator=13701087609, issue=Issue{id=1322626690153562922, tenantId=1146029695717560320, journalId=1235980733773295621, year='2021', volume='30', issue='1', pageStart='1', pageEnd='93', issueExtLink='null', onlineDate='null', pubDate='1610640000000', pubDateStr='2021-01-15', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1793268376148, creator='13701087609', updateTime=1793269030229, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322629433626837820, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322626690153562922, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322629433626837821, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322626690153562922, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=1, endPage=5, ext={EN=ArticleExt(id=1322626730116890675, articleId=1322626729902981170, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Analysis on orphan drug security policy from the perspective of drug life cycle in China, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

By combing the relevant policies of national and local orphan drug security policy, this paper analyzed the current situation of orphan drug security policy in China from the perspective of drug life cycle, and puted forward corresponding countermeasures and suggestions. In this paper, by consulting the relevant literature, searching the national and local government websites and the network platforms of rare disease-related organizations, combed the policies in the stages of drug research and development, registration, pricing and reimbursement, supply, post-market supervision (drug vigilance) and diagnosis and treatment of rare diseases from 2015 to 2020. In the past five years, the state and various ministries have issued a series of orphan drug protection policies, as well as some provinces and cities issued some orphan drug reimbursement policies, but there is no search for China's special post-market supervision policy for orphan drugs. It is suggested that under the premise of multi-sector cooperation, our country can set up full-time departments for rare diseases and orphan drug protection to provide diversified protection measures for patients with rare diseases.

, authors=Ni YUAN^{1, 2}, Na ZHOU², Hai-jun ZHANG³, Zheng LI², Xu ZHANG², Yong WANG¹, authorsList=Ni YUAN, Na ZHOU, Hai-jun ZHANG, Zheng LI, Xu ZHANG, Yong WANG, authorCompany=null, correspAuthors=Yong WANG, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1322626730372743220, articleId=1322626729902981170, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=药品全生命周期视角下中国罕见病药物保障政策简析, columnId=1236331162679955859, journalTitle=中国新药杂志, columnName=新药述评与论坛, runingTitle=null, highlight=null, articleAbstract=

通过梳理我国国家及地方罕见病药物保障方面的相关政策，从药品全生命周期的角度探析我国罕见病药物保障现状，并提出相应的对策建议。本文通过查阅相关文献，搜索国家及地方政府网站和罕见病相关组织的网络平台，梳理了2015—2020年在罕见病药物研发阶段、注册阶段、定价与报销阶段、供应阶段、上市后监管阶段（药物警戒）与罕见病诊疗等阶段的政策。近5年来，国家和各部委出台了系列罕见病药物保障政策，以及部分省市出台了罕见病药物报销政策，但目前尚未检索到我国专门针对罕见病药物上市后监管的政策。建议在多部门合作的前提下，国家能成立罕见病及其药物保障的专职部门，为罕见病患者提供多元化的保障措施。

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