In recent years, a lot has happened surrounding the development and evolution of the eCTD standard. You have probably already sat through an eCTD 4.0 presentation at an industry conference or an internal meeting and heard about some of the deliberations and revisions going on behind the scenes. In short, life science organizations, authorities, and vendors alike have been waiting for things to unfold for quite some time.
The first time a client asked me about my company’s plan for eCTD 4.0 was back in 2007. Ten years later, we will need to follow through on my answer of “We are working through the specifications and will support eCTD 4.0 as it comes into use.” Implementation guides from the ICH, FDA, EMA, and PMDA (Japan) have all been drafted. While there are several new regulatory initiatives on the horizon, such as IDMP and Structured Content, the momentum for eCTD 4.0 is clearly pushing forward. However, each of the players has a slightly different motivation for eCTD 4.0 acceptance by the industry:
So what motivation is there for you, as a sponsor company, to move to eCTD 4.0?
So what’s new in eCTD 4.0 for sponsor companies? Here are the most important changes from a sponsor perspective:
Over the past two years, every US client I have worked with has asked the same question: “Should we switch to the newest FDA eCTD specification?” I have found that the answer is based on two other questions: 1.) Are you already submitting eCTDs? and 2.) Are you submitting Advertising and Promotional Materials to the FDA? Even for clients who have decided to upgrade to the newest version of the specifications on their own, we find that those questions correlate with their decision.
In our next blog, we will take a look at the timelines from various agencies for eCTD 4.0. While there will be a transition period to continue to submit eCTD 3.2 before eCTD 4.0 becomes mandatory, as a sponsor, you do not want to delay your transition to eCTD 4.0 for too long. We will discuss the tasks that are necessary from a technical perspective to transition to eCTD 4.0 in the third blog in our series. They will require planning and time, so companies that delay implementation until the specification becomes required may find they have issues with getting all of their submissions sent in time. The transition period puts sponsor companies in a similar situation to what we have seen with the newest FDA specifications. So as you decide when to upgrade your submissions from eCTD 3.2 to eCTD 4.0, what questions should you ask?
From my perspective, here are the four most important ones:
1. Have you needed to correct metadata on your submissions consistently?
2. Are you often re-using the same document content across different applications?
3. Are you planning new submissions for multiple regions? What are your plans for re-using the content?
4. How much communication are you doing with the FDA? Are you managing multiple Meeting Requests or Requests for Information/Advice at a time?
The more “yes’s” you have to the questions above, the more benefit you will see from eCTD 4.0. This may drive you to implement eCTD 4.0 sooner rather than later.
In our next blog post, we will help you to decode all of the information being presented about eCTD 4.0 with a dive into the terminology and concepts. In our third post, we will take a look at Health Agency timelines and implementation concerns.
In the meantime, you can contact EXTEDO with any questions about eCTD 4.0 and for help with your eCTD 4.0 planning or download our whitepaper: eCTD 4.0: Objectives, benefits & impact on life science organizations