Hello, esteemed Regulatory professionals! As a member of the life science industry, you are likely to be familiar with the electronic Common Technical Document (eCTD) submission format that is revolutionizing the Life Sciences Regulatory industry. Its standardized structure is a true game-changer. With this blog, we aim to provide valuable insights into the best practices for eCTD submissions. So, let's get ready to become eCTD submission experts together!

Imagine working on a new drug to treat a devastating disease. After years of hard work, you've finally gathered the data you need to submit a regulatory submission to the FDA. But then, you realize that your electronic records and eSignatures don't comply with 21 CFR Part 11. This is a scenario that no one wants to find themselves in. The world of regulatory compliance is complex and ever evolving. With new regulations being introduced all the time, it can be difficult for businesses to keep up.

In the dynamic world of pharmaceuticals, the role of real-world data (RWD) and real-world evidence (RWE) is becoming more pivotal. These tools provide a bridge between the controlled environment of clinical trials and the real-world complexities of patient care. Several pharmaceutical companies have successfully used RWD/RWE to support their regulatory submissions.

Since 2003, eCTD has been accepted by several Health Authorities around the world. Its standard has evolved incrementally over time. Based on the Health Level Seven (HL7) standard called RPS (Regulated Product Submission), eCTD 4.0 brings in major changes and introduces certain substantial updates. The updates focus on addressing a few key constraints that both Agencies and sponsors have discovered over the last two (02) decades.

Pharmaceutical professionals in the Regulatory space face complicated, rigorous, and ever-evolving requirements for the Regulatory approval of products in any market. But as technology advances, our ability to obtain data from other sources also changes. The amount of data in the Life Sciences industry is rising exponentially. The rise of the required information within Regulatory submissions occurs due to the fact that patients can have safer and more effective treatments coming into the market.