Structured Product Labeling (SPL) is a document markup standard approved by Health Level Seven (HL7) and adopted by the U.S. Food & Drug Administration (FDA) as a mechanism for exchanging product and facility information for regulatory submission in an electronic format.

The FDA’s SPL requirements have undergone a lot of developments over the past several years. As part of those developments, the FDA no longer accepts drug registrations and listings in paper forms. For nearly two decades, sponsors of pharmaceutical products have been mandated to submit labeling content in XML format compliant with the SPL standard. In 2005, this requirement was extended to biologics; and in 2009 was also applied to over the counter (OTC) and veterinary medicinal products, with requirements to include drug establishment registration, and drug listing information. All requests including national drug code (NDC) labels, establishment registration and drug listing data are required to be filed in fully electronic, SPL-compliant submissions.

The SPL requirements consist of two sections: Product Data Elements, which include the pharmaceutical, quality and packaging information; and Narrative Content, which includes the information related to the clinical use and safety of the product.

IQVIA’s SPL services include authoring, revision, versioning, validation, and submission of SPLs for the following categories:

• Establishment registration
• NDC / NHRC registration
• Drug / Product Listing
• Bulk Ingredient
• Human drug prescription labels
• Blanket no change certification
• Generic drug user fee amendments (GDUFA) self-identification
• Lot distribution reports
• Content of labeling
• REMS (Risk Evaluation & Mitigation Strategy)

Structured Product Monograph (SPM) Management Services:

The Canadian regulatory authority, Health Canada, has begun an initiative to transform product monograph (PM) into a structured extensible markup language (XML) format for drug labeling. The XML PM should include PM information, organizational information, and product metadata. The initiative currently proposed by Health Canada only currently only applies to existing and new PMs. However, Health Canada plans to make SPM mandatory by the end of 2023.

Implementing SPM will improve the searchability of PMs, as the XML format is machine readable and will make it easier to search for and find the needed product information. This controlled structure of SPM will improve consistency across all drug products. The move to XML PM will positively impact process around product monograph preparation, submission and approval for human prescription drugs marketed, sold, or distributed in Canada.

Creating an SPL and SPM is a lengthy and time-consuming process. Implementing SPM will include the transition of regulatory activities for new drug submission (NDS), supplemental new drug submission (SNDS), abbreviated new drug submission (ANDS) and supplemental abbreviated new drug submission (SANDS). So, it is important to get it right the first time. Otherwise, any missed errors, such as typos, missing data or incorrect data will impact the quality of products by being carried forward to the product label, packaging inserts, etc. This is where IQVIA can ensure that the SPL/SPM is appropriately reviewed and approved internally before submission to the regulatory authorities.

Case study #1 – Indian Bulk Drug Manufacturer Speeds Product Approval with FDA

Situation

One of the fastest growing bulk drugs manufacturers and leading chemical supplier company in India needed regulatory support for drug master file (DMF) submission and maintenance including US agent services.

Solution

• Self-identification of facility site.
• Annual drug establishment registration.
• Drug listing and renewals for active pharmaceutical ingredients (APIs).
• Lifecycle maintenance (electronic submissions and gateway submissions) for API and DMFs.
• US agent services.
• Yearly coordination of drug listing quantity reporting to FDA per site, developing submissions in the required format on the FDA NextGen portal which was implemented as part of the Coronavirus Aid, Relief, and Economic Security Act (CARES).

Results

Throughout the journey, IQVIA supported the manufacturer in converting their label into SPL XML format and managing the life cycle of SPL. This was executed by enabling version control, using the FDA’s specified standard parameters, with complete validation. These changes were implemented within a short turn-around time – helping the customer provide a prompt response to the FDA, thereby assisting in a faster product approval. IQVIA also aided the customer on the FDA’s new guidance stemming from the CARES act and submitted the data without any deviation in the timeline specified by the FDA.

Case study #2 – European Drug Substance Manufacturer Outsources DRLS Management

Situation

One major drug substance manufacturer in the European Union needed support in management of all drug registration and listing systems (DRLS) for their US market.

Solution

• Maintenance of licenses & listings.
• Maintenance of establishment registrations, as well as annual recertification and regulatory changes that occurred during the year.
• Preparation of generic drug user fee amendments (GDUFA) self-identification and renewals.
• Management of requests for new, or reassignment of, NDC labeler codes.
• Annual blanket no changes certification (BNCC).
• Yearly coordination of drug listing quantity reporting to FDA per site, with submission in the required format on the FDA NextGen portal.
• Lot distribution reports.

Results

IQVIA acted as a subject matter expert on FDA requirements for SPL, including stylesheets, document types, XML coding, etc. IQVIA also liaised with customer and the FDA to support the fast resolution of process-related queries.

For more information about IQVIA SPL (Structured Product Labeling) Management Services, please contact us.