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.