Bengaluru : Indian pharma industry has noted that the recent US FDA’s electronic submission of IND (investigational new drug application) safety reports to the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER) will bring in the much-desired competency and clarity.
In the age of technology driven practices, the global regulatory guidance holds immense significance as it is a radical shift from the conventional paper-based submissions. In the case of INDs, there are several factors that need to be recorded and here the electronic format adoption is seen to be easier for revisions in the submissions, said the industry.
Coming to the guidance from US FDA, it provides specifications and recommendations on how to submit electronic investigational new drug application safety reports. It discusses the format for the submission of IND safety reports required under 21 CFR as individual case safety reports to the FDA Adverse Event Reporting System (FAERS).
According to Prema Desai, pharma consultant, this guidance briefs on how to submit electronic investigational new drug application safety reports and it would facilitate a systematic format for the industry and bring in a system in reporting adverse events.
Sponsors will be able to access future revisions of this guide through the FAERS electronic submissions web page and will provide information on the changes made to previous versions, she added.
Further, the regulations state that the sponsors should consult the guidance and web pages for other aspects of electronic IND safety reporting. These cover: US FDA Regional Implementation Guide of Individual Case Safety Reports for Drug and Biological Products. The FAERS Electronic Submissions web page for instructions on submission of ICSRs. Guidance for industry to provide submissions in electronic format the post marketing safety reports for instructions on contingency plans for submission of safety reports, for notification of receipt of submissions, and contingencies when the submissions systems are temporarily unavailable.
The IND safety reports that are not submitted to FAERS are those of the overall findings or pooled analyses from published and unpublished in vitro, animal, epidemiological, or clinical studies and increased rate of occurrences of serious suspected adverse reactions. This should be submitted using the Safety Report file-tag in eCTD section 4.2.3, Toxicology.
The regulatory authority has also noted that product names for Investigational Drugs, sponsors will need to use the established name which is generally the United States adopted name or international nonproprietary name, if applicable, in the appropriate E2B which is an electronic transmission of adverse event information for investigational drugs.
From an Indian pharma stand point companies like Glenmark, Lupin, Sun Pharma, Aurobindo, Zydus submit INDs.