The US Food and Drug Administration (FDA) has issued a draft guidance for the pharma and biotechnology industry to provide regulatory submissions in electronic format. This would be related to certain human pharmaceutical product applications. The companies will now have to adopt the eCTD (electronic-Common Technical Document) specifications. The industry has appreciated this draft and sees that this effort by the global regulatory authority would create transparency in submissions, efficient and faster turnarounds.

The technical specification documents of the guidelines indicates how sponsors and applicants must organize the content they submit to the USFDA via electronic mode under section 745A(a) of the FD&C Act. When finalised, this guidance will supersede the regulation for industry titled ‘Providing Regulatory Submissions in Electronic Format Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications’ that was issued in June 2008.

While the indsutry will need to submit their comments of this draft guidance before October 1,2014, the US FDA has indicated that it would take 24 months for this document to be finalised and implemented.

According to Kaushik Desai, Hon. Secretary, Indian Pharmaceutical Association, even though it would take two years for the guidance to be enforced, Indian pharma and biotechnology companies should be proactive and arm themselves to be ready for electronic submission. The effort by US FDA to insist on electronic submissions would transform the entire process of communicating with the regulator. Therefore, this draft guidance should be looked on by the industry as a future recommendation document and make efforts to augment their capabilities in this line of operation.

Industry experts pointed out that in an age of small machines, technology would only enable increased efficiency and expertise. In such a situation, there is need for constant training of personnel across the cadres.

“The best part of the guidance is that it will create a new age of simplification in submissions, adoption of paper-less procedures and initiate speedy approvals of applications, noted Desai.

According to the regulatory authority, submissions that are not presented electronically in the format specified will not be accepted, unless exempted from the electronic submission requirement.

FDA considers certain master files like the new drug application (NDA), Abbreviated New Drug Application (ANDA), Biologic Licence Application (BLA) or Investigational New Drug (IND) and therefore to fall within the scope of the requirements set forth in section 745A.

The requirements to submit electronically under this guidance would be that sponsors and applicants should use the version of eCTD specified in the Data Standards Catalog currently in effect.

The types of submissions that are exempted from the electronic submission are devices regulated by Centre for Biologicals Evaluation Research (CBER) as biological products under section 351 of the PHS Act (42 U.S.C. 262) which are intended for use in screening donated blood for transfusion-transmissible diseases.

For purposes of this guidance, the term noncommercial products refers to products that are not intended to be distributed commercially and includes investigator-sponsored INDs, emergency-use INDs, and treatment INDs.