(1)第六项LIST OF APPROVED NEW DRUG,列出批准的新药页面,网址:cdsco.nic.in/forms/list (2)第一项CT APPROVAL 2015,第三项CT APPROVAL 2013,第四项CT Approvals,第七项CT APPROVAL 2016-2018,均是与临床试验相关的记录,点击进入后下载PDF即可查看 (3)第二项COPPs granted by CDSCO for Ayurvedic Products...
under rule 122-e of drugs and cosmetics rules, a new drug includes anything that has bulk drug substance or is a phytopharmaceutical drug. it has not been used in the country with the conditions prescribed. it hasn’t also been recognized as safe by the licencing authority mentioned under ...
The Central Drugs Standard Control Organisation (CDSCO) has introduced a system of formal Pre-submission Meetings (PSM) of applicants with CDSCO officers and subject experts to discuss regulatory pathway in respect of specific application for approval of clinical trial, new drug, medical devices, etc...