FDA Delays eCTD Requirements for Master Files

In a revised guidance released Friday, FDA says it is delaying the requirement for drug master files (DMF) and biological product files (BPF) to be submitted in eCTD format until 5 May 2018.

Other documents, such as new drug applications (NDAs), abbreviated new drug applications (ANDAs) and biologics license applications (BLAs) must still meet the 5 May 2017 deadline.

In 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA) gave FDA the authority to require the use of specific electronic formats for submissions of drugs and biologics to the agency. However, in order to require the use of a specific electronic format, FDA must give industry 24 months after the publication of final guidance detailing the criteria and timetable for the requirements.

In its May 2015 revision to the guidance, Providing Regulatory Submissions in Electronic Format—Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications, FDA said it would require the use of eCTD format for NDAs, ANDAs, BLAs and master files.

However, FDA is extending the date to comply with the requirement for master files to 5 May 2018 in response to concerns that some companies might not be able to meet the rapidly approaching deadlines.

"FDA has determined, in response to industry comments and internal review that there have been challenges with submission of master files in eCTD format, and eCTD uptake data for master files in particular indicated that adhering to the May 5, 2017 date could have led to high rejection rates of master files and thus slower FDA review processes," FDA writes.

FDA's Guidance: Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications Guidance

Source: RAPS