https://www.taxtmi.com/forum/issue?id=4756 Under Schedule Y, clinical trials must follow Phase I-IV definitions and category-based review tracks; applications require chemistry, manufacturing and control data, preclinical studies, protocols, investigator brochures, informed consent, and ethical committee submission. After trial completion a new drug application using Form 44 with full preclinical and clinical information, foreign marketing status, labels and samples is filed for regulatory review, typically taking many months. en-us Tue, 25 Sep 2012 18:17:40 +0530 Thu, 23 Jan 2025 15:57:53 +0530 TaxTMI RSS Generator https://www.taxtmi.com/forum/issue?id=4756 Under Schedule Y, clinical trials must follow Phase I-IV definitions and category-based review tracks; applications require chemistry, manufacturing and control data, preclinical studies, protocols, investigator brochures, informed consent, and ethical committee submission. After trial completion a new drug application using Form 44 with full preclinical and clinical information, foreign marketing status, labels and samples is filed for regulatory review, typically taking many months. Discussion-Forum Customs Tue, 25 Sep 2012 18:17:40 +0530 https://www.taxtmi.com/forum/issue?id=4756