How to Interpret the Latest FDA Guidance on Manufacturing Establishment Information and its Relationship to IDMP Standards

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Editor’s Note: This is the first in a series of posts related to the Identification of Medicinal Products (IDMP) written by CAPT Vada A. Perkins (ret) that will appear on the eCTD Summit. Mr. Perkins is the Founder and Managing Principal of IDENTIFICA, a global life sciences consulting and IT firm specializing in global product lifecycle data management.

During my tenure at the FDA I had the opportunity to work on the recently published draft guidance Providing Regulatory Submissions in Electronic Format – Submission of Manufacturing Establishment Information (published December 28, 2016). The intent of the draft guidance is to help industry with the most pressing problems related to establishment information, which include:

  • Clearly identifying establishment information that’s presented in multiple locations within an application
  • Unstructured content in a PDF presentation doesn’t lend itself to validation and effective use/reuse of in information in any capacity through automated means

More specifically, the draft guidance on manufacturing establishment information coordinates all of the information about an establishment and its associated business operations into one structured format. The draft guidance states, “Electronic submissions of manufacturing establishment information (MEI) must include complete information on the locations of all manufacturing sites,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The draft guidance makes direct mention of the HL7 SPL message exchange format which is no coincidence, given that, to name a few, establishment registration and product listing, self-identification of generic drug facilities, lot distribution reports, and registration of human drug compounding outsourcing facilities, are submitted in this exact message format. (for a full list please visit the FDA website on Data Standards/Structured Product Labeling).

Here are three important points to note from the MEI guidance pertaining to SPL:

  • The format specified is a consolidated file of MEI in HL7 Version 3: SPL
  • FDA may refuse to file (RTF) or refuse to receive (RTR) an electronic submission unless it conforms to the HL7 V3 SPL format in one consolidated file
  • No waivers from this format will be issued

FDA and Identification of Medicinal Products (IDMP)

From an international standards perspective, the question that always comes up is ‘Will the FDA follow the ISO IDMP standards?’

To be clear, the FDA has made no official statement as explicit as their EU counterpart made legislatively. However, FDA has publicly stated that a Federal Register notice to this effect would be forthcoming when appropriate. Let’s not forget that the next iteration of the ISO IDMP standards and corresponding specifications have yet to be officially published by ISO. It would seem premature to make an announcement until the standards were officially published.

With that said, a lot of insight into FDA’s intentions can already be found by analyzing what’s been implemented or made publicly available to date.

If we simply connect the dots based on what FDA has implemented to date, what they’ve said publicly, and what information has been published related to future regulatory activities, the answer to the question ‘Will FDA follow the ISO IDMP standards?’ can be inferred.

The fact that HL7 Version 3 Common Product Model (CPM) and SPL are normative, i.e., required, as the exchange format in ISO IDMP, leads to the reasonable conclusion that FDA is in line, in both content and message, with the ISO IDMP standards and corresponding technical specifications that are due for publication in 2017.

 

Author: Vada Perkins

Vada A. Perkins is the co-editor of the ISO IDMP medicinal and pharmaceutical product standards/technical specifications, ISO IDMP Topic Lead and SME for the US delegation (ISO TC 215), and former IDMP Topic Lead and SME at the U.S. Food and Drug Administration (FDA). He is the Managing Principal of IDENTIFICA, a global life sciences consulting and IT firm specializing in global product lifecycle data management. Visit www.identifica.global for more information on IDENTIFICA’s comprehensive regulatory subject matter and technical expertise.

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