Clinical Trial Application (CTA) submission in India

A Clinical Trial Application (CTA) is submitted to regulatory authority (Drugs Controller General of India) to seek approval for conduct of a clinical trial in India. Form 44 is an application made for grant of permission to import or manufacture a new drug or to undertake Clinical Trial. The trial sponsor has to submit the application (Form 44) and documents pertaining to chemical and pharmaceutical information, animal pharmacology, toxicology data and clinical pharmacology data.  Other trial-related documents that must be submitted for approval include the Investigator’s Brochure, trial protocol, case report form, informed consent form, patient information sheet, investigator’s undertaking and IEC approvals (if obtained  during review process). Regulatory status of the trial in other participating countries also needs to be reported. Additional requirements exist for studies in special populations, e.g., children, pregnant women, nursing women, elderly patients, patients with renal or other organ system failure, and those on specific concomitant medication(s).

Submission of clinical trial applications have been classified into two categories: A and B since 1st December 2006. Category A trial submission comprises of protocols which have been approved by EMEA or regulatory authorities in US, UK, Japan, Australia, Canada, Germany, Switzerland or South Africa. The projected timelines for approval of Category A application is around two to four weeks. Category B trial submission undergoes the standard review process by expert committee and the turnaround time for approval is about eight to twelve weeks. An impediment in approval timelines occur in case of incomplete applications or due to delay in resolution of queries by the sponsor.  If a submission is made under category B and later approvals are sought from a Category A country still the submission category cannot be modified. Review period may also get prolonged if Drugs Controller General of India (DCGI) requests assistance from Indian Council for Medical Research (ICMR) or Department of Biotechnology (DBT) based on the application.

We at WorkSure™ support in preparation of Clinical Trial Application and related documents viz. Investigator’s Brochure, trial protocol, case report form, informed consent form, patient information sheet, EC submission document etc. WorkSure™ also provides technical expert representation to undertake discussions with regulatory authority.