3/13付でインドCDSCOから、2019年の新薬および臨床試験規則に関する懸念と不確実性に対処する一連の通知が発出されています。
また本件に絡んで、3/3付のRAPSがAsia Regulatory Roundup内に「India Addresses Multiple Concerns Related to new Drugs and Clinical Trial Rules」と題して記事に取り上げています。
関係者および興味のある方は、下記URLsの通知並びにニュース記事をご参照ください。
l3/13付「Testing of all categories of new drugs for their approval」
https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTc0NA
l3/13付「Requirement of CMC documents for approval of additional indication of an already drug product」
https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTc0Mg
l3/13付「Requirement of process validation report for permission to conduct Clinical trial BA-BE studies」
https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTc0Mw
l3/13付「Guidelines for approval of synthetically manufactured drug which has been previously approved as r-DNA derived drug」
https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTc0MQ
l3/17付RAPS「India Addresses Multiple Concerns Related to new Drugs and Clinical Trial Rules」
https://www.raps.org/news-and-articles/news-articles/2020/3/asia-regulatory-roundup-tga-partly-suspends-overse
また本件に絡んで、3/3付のRAPSがAsia Regulatory Roundup内に「India Addresses Multiple Concerns Related to new Drugs and Clinical Trial Rules」と題して記事に取り上げています。
関係者および興味のある方は、下記URLsの通知並びにニュース
l3/13付「Testing of all categories of new drugs for their approval」
https://cdsco.gov.in/opencms/
l3/13付「Requirement of CMC documents for approval of additional indication of an already drug product」
https://cdsco.gov.in/opencms/
l3/13付「Requirement of process validation report for permission to conduct Clinical trial BA-BE studies」
https://cdsco.gov.in/opencms/
l3/13付「Guidelines for approval of synthetically manufactured drug which has been previously approved as r-DNA derived drug」
https://cdsco.gov.in/opencms/
l3/17付RAPS「India Addresses Multiple Concerns Related to new Drugs and Clinical Trial Rules」
https://www.raps.org/news-and-
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