Simultaneous eCTD Submissions to Multiple Regions

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Traditionally, a pharmaceutical company would seek to have a drug approved in one region, and then move to other regions around the world to seek approval. Typically, companies would seek approval in their country of origin, then pursue the biggest markets, and finally focus on the rest of the world.

The advent of CTD provided a common organizational structure to create submissions around the world. The ability to reuse large parts of submissions created for one region to submit to another provided the opportunity to submit to more than one region at the same time. Furthermore, with electronic submissions, the ability to reuse and manage submissions was greatly streamlined, while also introducing some new challenges. Namely, with the realistic opportunity to simultaneously submit to multiple regions, there is an increasing pressure to provide new applications to major markets at the same time.

So the question becomes: Is it advisable to submit to multiple regions at once?

From experience we know that simultaneous submission to multiple regions is possible; however, planning this approach is directly related to its success. Oftentimes when new filings are created by the regulatory operations group, it is an all-hands on deck experience with everyone working to 110% of capacity. Once the submission is out the door and the adrenaline has worn off, fatigue sets in. Naturally, your team is exhausted, the personal and vacation days that were put off are taken, and your staff is no longer capable of producing at heroic levels. Fortunately, the number of follow-ups and responses after the initial submission is manageable to a single agency with reduced resources. Nevertheless, if your team chooses to submit to two or three or (gulp!) more agencies at the same time, the number of commitments for follow-ups and responses to the agencies after the initial filings will overlap from a timing perspective. That said, the information requests will diverge. This leaves you vulnerable to having too much work and too few resources.

The key to success is planning and communication. Planning far ahead of the actual submission and setting achievable milestones and expectations with the entire team is essential for success. Communication among the many contributors is important because the decisions and delays upstream have tremendous impact on other team members. The earlier you can finalize sections of the application, the easier it will be to handle the last minute changes which are inevitable. For example, Module 4 can realistically be locked down, finalized, and published six months in advance of the actual submission date. By finalizing sections of your submission in advance and allotting enough time for multiple reviews, you ensure that a high quality submission is being built throughout the process.

Lastly, during the planning process you need to map out the post-filing commitments for each region that you are submitting to, and ensure you have the resources in place to manage that process. You may find that delaying one submission in a region by two weeks will provide a less stressful and more realistic project plan for your team.

Author: Rahul Mistry

Rahul Mistry is a veteran of the software industry. Mr. Mistry has two decades experience working in the technology product and services field. He was instrumental in the development of the eCTD REVIEW™ and VALIDATE™ software now used exclusively by the U.S. Food & Drug Administration to assess the technical integrity of each drug application the FDA receives.

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