Regulatory Submission Software

Regulatory submission software takes the guesswork out of Structured Product Labeling (SPL)/Structured Product Monograph (SPM) submissions by giving you real-time validations. SPL Portal by Intagras is the all-in-one solution you need to ensure your regulatory submissions are compliant and complete.

Regulatory Submission Software

What Are Regulatory Submissions?

To bring its products to market, a pharmaceutical company’s regulatory documentation must be submitted and approved by that market’s regulatory authority. Regulatory submissions include product registrations, facility registrations and any associated documents.

What is Regulatory Submission Software?

Companies utilize regulatory submission software to ensure the regulatory compliance of FDA and Health Canada submissions. The FDA and Health Canada are regulatory authorities that require regulatory submissions to be made in a specific Structured Product Labeling (SPL) (in the U.S.) or Structured Product Monograph (SPM) format (in Canada), which are updated regularly.

Without regulatory submission software, you must navigate the confusing maze of regulatory submissions on your own. SPL Portal is the regulatory industry’s first and leading SaaS solution for SPL/SPM creation and management. SPL Portal users also get access to our team of experts who interact with the FDA every day.

Where Do Regulatory Submissions Go?

In the United States, Structured Product Label (SPL) submissions are sent to the FDA. Structured Product Monograph (SPM) submissions go to Health Canada.

FDA Submissions

Within the FDA are three centers for product label submissions: the Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), and the Center for Veterinary Medicine (CVM). CBER protects public health by making sure biological products are safe and effective, while CDER and CVM ensure the safety of over-the-counter and prescription drugs for humans and animals, respectively.

Pharmaceutical companies can easily navigate FDA submissions through the SPL Portal, which serves as one XML repository for your product labeling.

Health Canada Submissions

Currently, SPM drug submissions to Health Canada are voluntary, but the expectation is that Health Canada submissions will be mandatory starting at the end of 2022 or the beginning of 2023, and they will only be required when there is a new drug registration or an update to an existing drug registration. The good news is SPL Portal can manage your Health Canada submissions with ease, so when it’s time to make the switch, you have a reliable system that can take care of your submissions without delay.
 
Currently, SPM drug submissions to Health Canada are voluntary, but the expectation is that Health Canada submissions will be mandatory starting at the end of 2022 or the beginning of 2023, and they will only be required when there is a new drug registration or an update to an existing drug registration. The good news is SPL Portal can manage your Health Canada submissions with ease, so when it’s time to make the switch, you have a reliable system that can take care of your submissions without delay.

Where Do Regulatory Submissions Go?

In the United States, Structured Product Label (SPL) submissions are sent to the FDA. Structured Product Monograph (SPM) submissions go to Health Canada.

FDA Submissions

Within the FDA are three centers for product label submissions: the Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), and the Center for Veterinary Medicine (CVM). CBER protects public health by making sure biological products are safe and effective, while CDER and CVM ensure the safety of over-the-counter and prescription drugs for humans and animals, respectively.

Pharmaceutical companies can easily navigate FDA submissions through the SPL Portal, which serves as one XML repository for your product labeling.

Health Canada Submissions

Currently, SPM drug submissions to Health Canada are voluntary, but the expectation is that Health Canada submissions will be mandatory starting at the end of 2022 or the beginning of 2023, and they will only be required when there is a new drug registration or an update to an existing drug registration. The good news is SPL Portal can manage your Health Canada submissions with ease, so when it’s time to make the switch, you have a reliable system that can take care of your submissions without delay.

SPL Portal Supports SPM and 7 Types of FDA SPL Files

1. Drug Listing (FDA):

Drug establishments are required to provide the FDA with a current listing of all drugs/products manufactured, prepared, propagated, compounded or processed for sale in the United States at their facilities. Product Registrations/Listings SPL submissions are used to register/list those products with the FDA, as well as to register/list National Drug Codes (NDCs) with the FDA.

The product registration/listing information includes the product’s Labeler, Facility/Manufacturer information, key product details such as Active and Inactive Ingredients, Application Numbers, packaging configurations, and Content of Labeling.

For most drug products, the information provided in these SPL files is ultimately included in the National Library of Medicine DailyMed repository, which is publicly available via their website.

2. Establishment Registration

All U.S. drug manufacturers are required to be registered by the FDA. Before an establishment can be registered, it must have been assigned a DUNS number by Dun & Bradstreet.

Additionally, the registration file contains addresses and contact information, importer and U.S. Agent information for foreign establishments and the establishment’s business operations. A registrant can register multiple establishments within a single SPL file, but each establishment may only be listed in one registration.

Establishments must be registered within 5 days of beginning operations. Additionally, establishments must renew their registration annually between October 1 and December 31 of each year.

3. NDC Labeler Code Request

Products are identified and reported to the FDA using a unique, three-segment number called the National Drug Code (NDC), which serves as the FDA’s identifier for products/drugs. The first segment of the NDC is the Labeler Code. The FDA assigns this Code, which represents the Labeler entity that owns the product or markets it under their name or the establishment/facility that produces the product. Labeler Codes are obtained and maintained via the submission of NDC Labeler Code files to the FDA.
 

4. Lot Distribution Report

Lot Distribution Report (LDR) SPLs are sent to CBER for biologic drugs. These reports list all packages distributed within the reporting period and include the bulk, package, and label lot data, as well as the bulk manufacturer. Additionally, the same product data elements that are included in the drug listing file are included in the LDR. LDRs are required to be submitted every six months unless a waiver is received that allows for annual submission of the data to CBER.
 

5. Wholesale Drug Distributor/Third Party Labeler (WDD/3PL) Registration

Wholesale Drug Distributors and Third-Party Logistics Providers (3PL) are required to submit annually to the FDA an SPL file that contains license information for each state in which the facility conducts business. For those entities that operate as both wholesale drug distributors and 3PL providers, the same file may be used for both operations, but the license information is required to be entered for each operation, even if the license number for the respective state is the same between the two operations.1. 
 

When Are WDD/3PL Submissions Due?

Companies must submit WDD/3PL reports to the FDA between January 1 and March 31 every year.
 

6. GDUFA Self-Identification

All human generic drug facilities must be registered with the Generic Drug User Fee Amendments (GDUFA)-specific business operations each year by submitting a GDUFA Self-Identification SPL file. This is in addition to the Establishment Registration file that is also required each year. The GDUFA file contains similar information as the Establishment Registration, but because the operations differ, a separate file is required.
 

When Are GDUFA Submissions Due?

The FDA uses the GDUFA file to determine the GDUFA fees for the year. Therefore, companies must submit GDUFA files between May 1 and June 1.
 

7. Blanket No Change Certification

In order for a product to remain certified with the FDA, a product must have its listing information either updated based on a change or recertified using a Blanket No Change Certification (BNCC) SPL file. This file may only be used for those drugs that have not changed since the last submission and whose last SPL submission passes the current validation procedures. If an NDC Code has not been submitted using either of these methods in the current calendar year, the product and its NDC Code(s) will no longer be certified starting January 1 of the following year. All expired listings will be removed from the NDC Directory and may not be marketed or sold until the information is corrected.
 

When Are BNCC Submissions Due?

Organizations may submit BNCC files each year between October 1 and December 31.
 

Why Choose Intagras for your SPL/SPM Needs?

SPL Portal is the leading solution for SPL and SPM submissions. Converting Word files into SPLs can be challenging when you don’t know the idiosyncrasies. SPL Portal makes it possible to manage SPL submissions easily because it validates your files within the system. This means you don’t need to know how to code or keep up with current FDA guidance. SPL Portal handles all the details for you.

 If you are looking to outsource your SPL/SPM requirements, Intagras’ SPL outsourcing team has decades of experience with regulatory submissions and, since 2005, has worked closely with the FDA’s SPL experts. Our efficient documentation and process flow allow us to react to emergencies quickly and provide industry-leading turnaround times. If you have a labeling emergency or need help with a submission, our team can help.

Need regulatory submission help? Talk to us.

Have questions? Need more info? Talk to one of our experts or request a demo of our SPL Portal today.