Analysis of information sources in references of the Wikipedia article "孤儿药" in Chinese language version.
In an attempt to simplify the process for obtaining orphan status for medications targeting rare diseases, the FDA and the European Medicines Agency (EMA) have created a common application. ... U.S. and European regulators still will conduct independent reviews of application submissions to ensure the data submitted meet the legal and scientific requirements of their respective jurisdictions, the agencies said.Alt URL (页面存档备份,存于互联网档案馆)
我國依「罕見疾病及藥物審議委員會」的公告,則是以疾病盛行率萬分之一以下作為我國罕見疾病認定的標準。但罕病何其多,所以仍需經罕見疾病及藥物審議委員會認定,認定標準以罕見性〈萬分之一以下〉、治療困難性、遺傳性,三項指標來綜合認定。
In an attempt to simplify the process for obtaining orphan status for medications targeting rare diseases, the FDA and the European Medicines Agency (EMA) have created a common application. ... U.S. and European regulators still will conduct independent reviews of application submissions to ensure the data submitted meet the legal and scientific requirements of their respective jurisdictions, the agencies said.Alt URL (页面存档备份,存于互联网档案馆)
In an attempt to simplify the process for obtaining orphan status for medications targeting rare diseases, the FDA and the European Medicines Agency (EMA) have created a common application. ... U.S. and European regulators still will conduct independent reviews of application submissions to ensure the data submitted meet the legal and scientific requirements of their respective jurisdictions, the agencies said.Alt URL (页面存档备份,存于互联网档案馆)
我國依「罕見疾病及藥物審議委員會」的公告,則是以疾病盛行率萬分之一以下作為我國罕見疾病認定的標準。但罕病何其多,所以仍需經罕見疾病及藥物審議委員會認定,認定標準以罕見性〈萬分之一以下〉、治療困難性、遺傳性,三項指標來綜合認定。