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Automation
Sep 27, 2018

Automated solutions for eCTD baseline conversion

Transforming regulatory affairs processes just became one step easier with AI

  • Claire Colville Assistant Vice President, Genpact Pharmalink

For pharmaceutical companies and their regulatory affairs teams, 2018 heralds the end of Non-eCTD electronic Submission (NeeS) submissions for all European procedures (centralized, decentralized, and mutual recognition), with a mandatory requirement for submissions to be made in an electronic common technical document (eCTD). As of January 2019 the same will be required for all license updates to National Procedures.

Ensuring all submissions are now submitted via eCTD is due to the improved efficiency, compliance, and transparency in submissions. But the creation of an eCTD baseline can be challenging for many companies, as there are many factors they must take into account.

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Are you prepared?

As we prepare for the mandatory eCTD requirements for all national submissions in 2019, National Health Authorities are recommending that companies create the baseline in eCTD. Depending on the National Authority, the baseline may be Module 3 only, or Modules 2 to 5.

Nationally registered product dossiers vary in size and complexity. Some may not even have a full CTD dossier. And many made up of several different formats ranging from initial submissions in Notice to Applicants to CTD paper scans, PDFs, multiple license updates on paper, NeeS, and even some eCTD. The complexity of each dossier makes it difficult to determine exact volumes and scale.

As companies look for ways to reduce the burden of time, labor, and money in facilitating the creation of these baselines, many are turning to new technologies for a solution.

Mining for data compliance

Artificial intelligence and automation have rarely been seen within regulatory affairs activities – that is, until now.

Machine learning can automate the process of analyzing, identifying, and extracting information directly from authoritative source data to produce a full, consolidated baseline dossier of the most currently registered information.

The results? Compared to the traditional manual approach, which can take a subject matter expert between one and three days, with data mining the initial consolidation process can take less than 30 minutes. With such obvious benefits at a small scale, consider the impact for an overall portfolio-conversion project. In practice, that equates to cutting costs by over 30% and delivering projects more than 20% faster.

We believe in the power of transformation and want to help companies understand how technology can revolutionize their end-to-end processes.

Read more about how organizations are transforming regulatory affairs.

About the author

Claire Colville

Claire Colville

Assistant Vice President, Genpact Pharmalink

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