Structured Product Labeling (SPL) and Structure Product Monograph (SPM) are the mandatory document mark-up standards for the submission of label content, product and facility information and any subsequent changes to the existing label information in an electronic format. SPL format defines the structure and content of label information as per the United States Food and Drug Administration (US FDA), whereas SPM is for Health Canada (HC). Across the industry, there are many types of drug registration, drug labeling and drug listing requirements which can be submitted through various SPL and SPM submission types. Complying with all of them requires a sophisticated and one-stop solution.
Need for an SPL/SPM Software
To submit SPL/SPM to the health authorities, applicants must have a thorough understanding of the submissions in XML format to avoid errors that may cause reworks viz. incomplete data, improper hyperlinking, section misalignment, etc. Hence, the need of the hour is to deploy a robust submission tool to create, validate, store and submit complex content structures aligning with SPL/SPM standard in the region-specific formats.
SPL/SPM Software - Ideal Features for Consideration
An SPL/SPM software must be equipped with:
- Automated process to reduce the burden of the end-user
- A tracking module to provide information on all the stages during the submissions and also to follow the review comments until the SPL format finalization/approval
- A strong editor to work on multiple SPL formats that helps to create MS Word & PDF documents, Control Versions, Table borders, Audit Trails, etc.
- A comprehensive repository to efficiently maintain the SPL lifecycle
- An inbuilt validator to provide accurate files as per the FDA/HA's guidelines
- Feasibility to import the earlier submissions, which enables the user to handle all the Regulatory submissions in one repository
As manufacturers aiming at the US market-entry need to update their drug listing with the US FDA or submit blanket no certification SPL between October and December, Health Canada market-entrants must quickly adapt to SPM guidelines. In the process what should be the ideal approach? Integrate a one-stop-solution for SPL and SPM. Act wise and be compliant.
