Pharmaceutical manufacturers take note: The days of non-electronic submissions of establishment information to the US Food and Drug Administration (FDA) are coming to an end, possibly as soon as 2019.

On 28 December, FDA released draft guidance on the submission of manufacturing establishment information (MEI) in an electronic format.

Twenty-four months after the agency finalizes this guidance, all MEI contained in new drug applications, abbreviated new drug applications, biologics license applications and amendments, as well as supplements or resubmissions of these applications, must be provided electronically using the Health Level 7 (HL7) Version 3: Structured Product Labeling (SPL) standard.

Background

In terms of why this guidance and shift are necessary, FDA says that recently it has noticed that the required information on the manufacturing establishments is often provided in different sections throughout an application.

“This makes the MEI difficult to find and time-consuming to review. Consolidating the required electronic MEI to appear in a single location will facilitate the complete, timely, and accurate review of all manufacturing establishments involved in the preparation of a drug or biological product,” FDA says. “In addition, this consolidation of the MEI will help eliminate the inclusion and/or maintenance of potentially outdated and erroneous information that, lacking clear information in the submission, might otherwise be retrieved from other Agency files and will enable proper identification and timely evaluation of manufacturing establishments for conformance with requirements, including current good manufacturing practices.”

Moving Forward

To help resolve these issues, FDA is requiring that applicants consolidate the MEI into a single list encompassing (Field Establishment Identifier (FEI) number is recommended but not required):

• Establishment name and address: Specific information regarding the physical location (e.g., building number on a corporate campus or industrial complex)
• Unique Facility Identifier
• Contact information for the person responsible for scheduling inspections
• Specific manufacturing operations being conducted.

Electronic submissions of MEI must include complete information on the locations of all manufacturing sites, including packaging and control sites, for both drug substance and drug product. The agency notes that all noncommercial investigational new drug applications (INDs) are exempt from the MEI electronic submission requirements.

Providing Regulatory Submissions in Electronic Format—Submission of Manufacturing Establishment Information Guidance for Industry