If you are engaged in the pharmaceutical domain in the US, the Food and Drug Administration (FDA) authority will play a major part in your regulation and compliance process. Making regulatory submissions to the FDA is one area that could become a challenge for many organizations, and requires a solid plan for ensuring data security, efficiency and convenience.
FDA has a unified Electronic Submissions Gateway (ESG) for accepting and routing inbound submissions for most of its centers including Health Canada (HC). ESG provides additional flexibility for FDA electronic submissions by offering two transfer mechanisms to pick based on different organizational preferences: WebTrader and AS2.
WebTrader is FDA’s in-house developed application, that would be installed on the submitter’s premises/desktops for securely uploading submissions to FDA systems. It offers a browser-based graphical interface for users to manually choose the source files/content for their FDA submission, after which it will create a properly formatted .tar.gz archive compatible with FDA ESG on the local computer and transmit it to FDA over the local internet connection - with their own acceptable data security mechanisms in place. It authenticates using FDA’s own user registration system, and offers some additional functions like connecting network drives to pick source data.
AS2 is an industry-standard protocol, introduced in 2005 and brought into mainstream use by Walmart and other retailers. Although it is most popular for EDI (Electronic Data Interchange) activities in B2B domains like retail, shipping and logistics, the simple and flexible nature of the protocol makes AS2 suitable for transmitting any kind of document, including FDA submissions, natively fulfilling data security aspects of confidentiality, integrity, and non-repudiation. Because it is a generic protocol, submitters can use any preferred AS2 provider or platform, as long as it meets FDA AS2 requirements and has the capability to process multiple levels of acknowledgments returned by FDA for each electronic submission.
As mentioned before, FDA gives the freedom and flexibility to users to choose the submission mechanism that suits their needs; still, it is important to consider several factors when picking your FDA electronic submission mechanism for maximum efficiency, scalability and future-proof compatibility.
If you have a target of only a few dozen submissions per month (low-volume and infrequent), WebTrader would offer a simple and fast way to get going.
If you do not anticipate growth in your submission volume over the coming years, meaning that automation is not a priority - and a manual/human submission process is acceptable
WebTrader is a local application which reads source data from the local computer where it is installed. This means it would be usable as either:
individually installed on the submitters’ own computers, where each submitter locally has access to their own subset of source data; note, however, this involves the complexity and security risk of replicating sensitive medical data across multiple user-level computers, and the obvious need for keeping the user’s computer running while any submissions are ongoing - especially problematic with [large-sized (VLF)] submissions
centrally installed on an organization-level Windows server, which is then made available to all involved users through a mechanism like RDP (remote desktop protocol) over the corporate network; while this mitigates complexity and data security concerns to some extent, it requires users to have specialized software (like RDP clients) installed on their machines in order to access the central server
WebTrader takes care of the overall submission workflow including archive creation, upload, tracking of ACKs sent back from ESG and from individual centers, etc. So you can avoid any requirement for in-house expertise and specialized or custom-built software or data pipelines, and rely on the already-installed WebTrader application itself for all heavy lifting.
WebTrader is only compatible with Windows; so if you require a distributed installation (on individual user computers)
and do not have control over the target operating system, WebTrader may not be the right choice for you.
If your FDA submission frequency is beyond a few dozen per month - or is expected to grow beyond over the long run - AS2, despite its longer set-up process, would be a future-proof choice.
If automation - which cannot be easily achieved through the UI-based WebTrader - is on your roadmap, you would benefit from the various integration mechanisms offered by almost every AS2 vendor - to plug the FDA submission mechanism into the existing organizational workflow, thereby automating and streamlining it.
Being a generic and widespread protocol, AS2 products and providers offers several deployment options to choose from. While pay-as-you-go (SaaS - software-as-a-service) public-cloud solutions are also commonplace, handling sensitive clinical and pharmaceutical data often requires more stringent security and access control; thereby requiring on-premises, private-cloud or dedicated environments to hold and process relevant source data within the organization’s own control. On the other hand, if SaaS does happen to meet your requirements, you can still benefit from industry-grade data security combined with highly economical and flexible payment schemes.
Most AS2 products offer a web-based UI; so you can simply install the product on a central server (which has controlled access to submission source data) and grant suitable access levels to individual users/submitters; afterwards they can access it as a shared FDA electronic submissions interface - simply through their web browsers - to pick the source content (without involving any local upload and/or download), initiate a FDA submission, and simply log off or close the browser tab while the server takes care of the actual submission internals in the background. This centralization offers numerous additional benefits, such as the ability to audit and access-control user actions, introduce desired security and safety/backup mechanisms centrally to all data repositories, benefit from the organization’s own internal network/VPN robustness and security, etc.
Some AS2 products have additional features or even custom-tailored release lines for regulatory submissions, with specialized dashboards, automatic submission-archive generation capabilities, automated tracking and notifications on submission and ACK progress, and even similar built-in support for other major regulatory entities such as EMA (European Medicines Agency).
If your organization is also involved in supply chain activities for pharmaceutical products, clinical materials etc., chances are that you already have an AS2 or MFT (Managed File Transfer) solution in place; in that case, you can simply leverage the existing MFT product and infrastructure for the FDA submissions as well.
FDA electronic submissions will likely occupy a significant place in any medical or pharmaceutical organization’s workflow. If you anticipate a low and stable rate of manual FDA submissions across a handful of users, FDA’s own WebTrader application will usually meet your requirements. However if scalability, automation or robust security and safety compliance are among your priorities, it may be wise to engage an AS2-based regulatory submissions platform from the beginning itself.
Janaka is a Software Architect at Aayu Technologies. He is experienced in diverse areas including enterprise integration, B2B communication, and cloud and serverless technologies; and has been involved in the design and implementation of almost every Aayu product. Any interesting bug will keep him up overnight, as will tea, movies, and music.
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