Author: eCTD Submit

Deadlines. They have a habit of sneaking up.

Indeed, it’s hard to believe that it’s been 2 years since the changes to the FDA Adverse Event Reporting System (FAERS) were announced. And yet, here we are.

From 1^st April all submissions of Individual Case Safety Reports (ICSRs) must be electronically submitted via the ICH E2B(R3) standard; all legacy reporting methods, e.g. PDF MedWatch, E2B(R2), non-XML) are no longer allowed.

Why the change?

Electronic reporting of ICSRs via ICH E2B(R3) is driven by the need for greater efficiency in the reporting/review process. It will also bring reporting in line with the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use.

The new regulations will help to standardize and enhance data quality and improve safety signal monitoring, plus it will facilitate the use of AI to identify duplicate ICSRs and conduct causality assessments.

Is your organization affected?

In the majority of cases, application holders (both pre- and post-marketing) will be required to complete and submit ICSRs to FAERS. However, there are many other organizations involved that also have responsibility to report adverse drug reactions. These include contract development and manufacturing organizations, clinical research organizations and vendors. In addition, the reporting requirements apply to any organization with its name upon the label, such as manufacturers, packers and distributors.

eCTD Submit is ready to help

We’ve been working closely with our clients to ensure they’re ready for the 1^st April reporting adjustments. Hopefully, your organization is ready also, but if not don’t panic – eCTD Submit is here to help.

Our dynamic and highly experienced team can ensure that your reporting is compliant with the new requirements. For example, we can help set up your electronic submission gateway account (NextGen ESG) and assist with your XML test phase file submissions.

Under the new regulations, ICH E2B (R3) reporting can take one of three different routes:

• Unified Submission Portal – for sponsors who can produce E2B-compliant XML files with a low volume of ICSRs.
• AS2 gateway – for sponsors who can produce E2B-compliant XML files with a high volume of ICSRs.
• Safety Reporting Portal – for sponsors unable to produce E2B-compliant XML files.

If your submissions provider isn’t ready for 1^st April, reach out to eCTD Submit. It might feel like time is not on your side, but we most definitely are.

Letting go of your old eCTD consultant is no small feat. Here are a few things you might like to consider before reaching out.

When it comes to regulatory submissions, few eCTD consultants have more experience than eCTD Submit. We were there at the beginning when electronic submissions first started. Indeed, several members of our senior team were involved in the first ever test FDA submissions — even helping to design the original submission system.

Years of innovation

Over the past decade, hundreds of sponsors have trusted eCTD Submit to deliver tens of thousands of successful applications. Most new sponsors contacted us following recommendations from existing partners. This is something we are proud of, but that doesn’t mean we rest on our laurels.

We are continually looking for ways to improve the eCTD publishing process for our partners. For example, we have adopted a dynamic set up that increases responsiveness. It means we can put together a highly skilled team based on a sponsor’s specific needs. So, when timelines shift or projects change direction no one gets caught out.

Straightforward eCTD submission software

Another innovation occurred following sponsors’ complaints about other vendors clunky reviewing programs. So, we developed our own — The eCTD Navigator^TM. Intuitive, web-based and not just a viewer; it’s the complete eCTD submission and document review tool. All eCTD Navigator^TM documents appear exactly as required by the FDA. And both version and quality control are simply better.

If you’d like to find out what we can do for you, reach out today.

After all, when it comes to regulatory submissions, it’s good to know you’re in safe hands.

For years, we’ve been keeping our clients’ submission documents secure and easy to access. Because, as any sponsor knows, maintaining FDA submission records is not just a responsibility ‒ it’s a regulatory publishing requirement.

How do we achieve this? Well, first we use a document management platform that doesn’t lock you into a single system. This gives you full control with immediate access to any module, section, or document in your eCTD submission.

And locating documents couldn’t be easier with our Navigator^TM tool. It’s an intuitive web-based interface that mirrors the FDA’s lifecycle view. So, your view of your regulatory submission is the same as that of the FDA reviewer.

The dangers of taking a wrong turn

Failing to meet the FDA’s regulatory publishing requirements can lead to missed deadlines, which can increase costs – and greater costs mean unhappy management.

Often the delays have nothing to do with the sponsor. Many find themselves under pressure from the FDA due to their vendor’s choices. For example, a vendor may mistakenly:

• Use an outdated regulatory submission system that causes compliance risks – poor document management is major FDA compliance issue.
• Rely on an archaic, hard-to-navigate submission platform – an FTP site, for example. If the information requested by the FDA is not at your fingertips, you may quickly become the subject of a formal inspection finding.
• Be unclear as to where or how your submission is stored – this runs the risk of the FDA ruling your program as noncompliant.

You know where you are with eCTD Submit

At eCTD Submit we help smooth the path from early development right through to regulatory approval and beyond. After all, a well mapped out eCTD submission isn’t just helpful – it’s essential.

To find out more get in touch today.

Because with eCTD Submit you can improve accuracy, reduce costs, avoid delays and reach your destination sooner.