On December 29, 2016, FDA issued a new draft guidance regarding drugs and biologics entitled “Providing Regulatory Submissions in Electronic Format—Submission of Manufacturing Establishment Information.” 81 FR 96013 (Dec. 29, 2016). The guidance provides an overview of the requirements for a valid electronic submission of manufacturing establishment information (MEI) under section 745(a) of the Federal Food, Drug, and Cosmetic Act (FDCA) as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA).

Background

Applicants and holders of approved applications are required to submit MEI, e.g., contact information for each manufacturing establishment involved in the manufacture of the drug or biologic product and other information relating to the manufacture of the product. See 21 CFR 314.50(d)(1)(ii)(A), 601.2(a); Form FDA 356h, ‘‘Application to Market a New or Abbreviated New Drug or Biologic for Human Use” at 2. Currently, MEI is occasionally incomplete and dispersed throughout submissions, which causes delays in processing applications and sometimes leads to the inclusion of outdated and erroneous information, according to FDA.

New Requirements

To respond to these issues, the guidance requires that applicants submit as one electronic file a single consolidated list of information about each manufacturing establishment referenced in an application. The information must include:

  • the name and address of each establishment,
  • specific information regarding the establishment’s physical location,
  • the Unique Facility Identifier,
  • contact information for the person responsible for scheduling inspections at the establishment, and
  • the specific manufacturing operations conducted.

The submission 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 master files must comply with the new requirements, but exempts noncommercial investigational new drug applications (INDs). Specific formatting details are also clarified.

Companies must comply within two years after the draft guidance is finalized.

FDA requests that comments be submitted by February 27, 2017. The new guidance is available here.