**Summary:**
This notice, reference number F.No. 12044 9DCPT195, issued on [Date: 317 - assuming it means day 317 of a particular year, further clarification may be needed], by the Government of India, Directorate General of Health Services, Central Drugs Standard Control Organization, Drugs Controller General India, New Drugs Division, FDA Bhawan, Kotla Road, New Delhi-110002, concerns pre-submission meetings regarding new drugs and clinical trials. According to the New Drugs and Clinical Trials Rules 2019, any person intending to apply for a license or permission to import or manufacture new drugs, or to conduct clinical trials, may request a pre-submission meeting. This meeting allows applicants to seek guidance on the application process, clinical trial requirements, and other relevant aspects. The notice indicates that such pre-submission meeting requests will be addressed as they are received.
Key Entities Referenced
Drugs Standard Control Organization: An organization involved in drug regulation in India.
Drugs Controller General India: The head of the Drugs Standard Control Organization in India.
New Drugs Division: A division within the Drugs Standard Control Organization, likely responsible for new drug approvals.
FDA Bhawan, Kotla Road, New Delhi: The location of the Drugs Standard Control Organization office in Delhi.
New Drugs and Clinical Trials Rules 2019: A set of regulations governing the approval and conduct of clinical trials for new drugs in India.
clinical trial: A research study to evaluate the safety and effectiveness of new drugs or medical treatments.
import: The action of bringing goods or services into a country from abroad for sale.
manufacture: To make or produce something, typically on a large scale using machinery or industrial processes.
F.No. 12-04/4 9-DC(PT-195)
Government of India
Gunuree ae General of Health Services
ae rugs Standard Control Organization
of Drugs Controller General (India)
(New Drugs Division)
FDA Bhawan, Kotla Road,
New Delhi-110002
Date: 31)7!>-<-
NOTICE
Subject: Pre-submission meeting — reg.
Under the provision of New Drugs and Clinical Trials Rules 2019, any person
wi ) intends to make an application for grant of licence or permission for import or
facture of new drugs or to conduct clinical trial may, request by making an
ang 9 process, clinical trial and other requirements.
2gal 4, it is to mention that as and when application for a pre-
ating si received pe ee