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Closing the "Black Hole" of Global Regulatory Labeling Submission for Biopharma

White Paper Published By: SDL
Published:  Sep 20, 2019
Type:  White Paper
Length:  6 pages

In a global and highly regulated marketplace, pharmaceutical and biotech firms face a challenge in managing regulatory labeling submissions that meet multiple country and regional requirements in many different languages. This process has historically required substantial manual intervention and review by highly paid professionals, contributing to unnecessary costs and delays in medicinal product launches. Biopharma executives hope that new, cloud-based tools will help solve this costly dilemma.

To market their products globally, biopharmaceutical firms must ensure their product information complies with local regulatory filing requirements. Submissions often need to be revised to reflect in-country linguistic, formatting, and timing mandates. In-country compliance is usually overseen by local affiliates that manage the process internally. Tasks such as translation and formatting are typically outsourced to in-country providers.

For the corporate global regulatory affairs (GRA) function, establishing a link and maintaining compliance between the corporate source of truth that is managed centrally and the in-country labeling information that is on file with the local regulators represent a challenge that could be described as a "global regulatory labeling submission black hole."

Unfortunately, legacy linguistic technologies such as translation management and translation memory systems historically have come up short in capabilities for managing the dynamic nature of the labeling process, leading to substantial manual intervention in categories such as variations and update filings. Manual approaches invite errors and inconsistencies, and they increase the risks of mislabeling and delays while substantially increasing costs and associated overhead.

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