インドCDSCOから、新薬と臨床試験における申請について明確化する通知が複数発出されています。
本件について、2/25付のRAPSがAsia Regulatory Roundup内に「India’s CDSCO Clarifies Application of 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。
l2/18付FAQ「Notice regarding New Drugs dated 18.02.2020」
https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTU4OA ==
l2/20付Notice「Notice regarding Grant of Permission in Form CT-11/ CT-14/CT-15/ CT-17 under New Drugs and Clinical Trials rules 2019」
https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTYyMQ ==
l2/21付Notice「Notices for Streamlining Applications for New Drugs, Clinical Trials and Bioavailability/ Bioequivalence (BA/BE) Studies/ grant of COPP 1.Permission to conduct BA/BE study and Clinical trial. 2.Approval of FDCs containing new drugs. 3.Fixing of limit of impurities in the specification of INDs. 4.Pre-submission meeting. 5.Sub-acute toxicity study report for injectable products for BA/BE study in human for export. 6.Requirement of Stability Data for COPP」
https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTYyMg ==
l2/21付Notice「Notice regarding Processing of application for BA/BE permission issued in Form CT-07 and Import Licence issued in Form CT-17 for Export」
https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTYxOQ ==
l2/25付RAPS「India’s CDSCO Clarifies Application of new Drugs and Clinical Trial Rules」
https://www.raps.org/news-and-articles/news-articles/2020/2/asia-regulatory-roundup-tga-mulls-regulatory-refo
本件について、2/25付のRAPSがAsia Regulatory Roundup内に「India’s CDSCO Clarifies Application of 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。
l2/18付FAQ「Notice regarding New Drugs dated 18.02.2020」
https://cdsco.gov.in/opencms/
l2/20付Notice「Notice regarding Grant of Permission in Form CT-11/ CT-14/CT-15/ CT-17 under New Drugs and Clinical Trials rules 2019」
https://cdsco.gov.in/opencms/
l2/21付Notice「Notices for Streamlining Applications for New Drugs, Clinical Trials and Bioavailability/ Bioequivalence (BA/BE) Studies/ grant of COPP 1.Permission to conduct BA/BE study and Clinical trial. 2.Approval of FDCs containing new drugs. 3.Fixing of limit of impurities in the specification of INDs. 4.Pre-submission meeting. 5.Sub-acute toxicity study report for injectable products for BA/BE study in human for export. 6.Requirement of Stability Data for COPP」
https://cdsco.gov.in/opencms/
l2/21付Notice「Notice regarding Processing of application for BA/BE permission issued in Form CT-07 and Import Licence issued in Form CT-17 for Export」
https://cdsco.gov.in/opencms/
l2/25付RAPS「India’s CDSCO Clarifies Application of new Drugs and Clinical Trial Rules」
https://www.raps.org/news-and-
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