August 05, 2025

In the highly competitive world of life sciences, companies are continuously challenged to accelerate development timelines, minimize costs, and maintain scientific integrity. Literature-Based Submissions (LBS) have emerged as a powerful regulatory approach, allowing organizations to leverage existing scientific evidence to support their drug approval dossiers—often bypassing the need for new clinical or non-clinical studies. Understanding how to structure and execute an effective LBS can be a game-changer in speeding market access while satisfying global regulatory expectations.

What Is a Literature-Based Submission?

A Literature-Based Submission is a regulatory filing that utilizes published, peer-reviewed scientific literature as primary evidence for demonstrating the safety, efficacy, and sometimes the pharmacokinetics/pharmacodynamics (PK/PD) of an active pharmaceutical ingredient or product. This approach is especially applicable when the drug substance has a long-standing history of clinical use—usually more than 10 years—in major markets such as the US, EU, UK, Canada, Australia, and New Zealand.

LBS are well-suited for scenarios including label extensions, dosage form modifications, or the pursuit of new therapeutic indications where robust company-generated clinical data are unavailable or unnecessary. Typically, quality (CTD Module 3) data still require original studies, while Modules 4 (non-clinical) and 5 (clinical) can rely heavily on existing published evidence.

When Is LBS the Right Strategy?

LBS offers distinct advantages and is commonly used for:

  • Generics containing well-established active substances
  • Product repurposing or expansions based on real-world data
  • Regulatory applications in reliance or acceptance markets where literature is accepted as part of the evidence package
  • Orphan drug approvals based on case series and observational studies alone

Using LBS helps avoid costly, time-consuming new trials while utilizing the wealth of global scientific knowledge available.

Building a Successful Literature-Based Submission: Best Practices

  1. Early Engagement with Regulators
    Discuss your intention to submit an LBS early with agencies such as the TGA or EMA. Early alignment clarifies acceptability criteria, aligns expectations, and smooths the pathway ahead.
  2. Comprehensive Literature Search Strategy
    A robust search extends beyond popular databases like PubMed. Incorporate EMBASE, Cochrane, Web of Science, and specialized medical databases. Applying structured frameworks such as PICO (Patient, Intervention, Comparison, Outcome) ensures comprehensive and relevant retrieval.
  3. Full Transparency and Documentation
    Document every step—search protocols, inclusion/exclusion criteria, and appraisal methods (using tools like GRADE or CASP). This transparency fosters credibility and regulatory trust.
  4. Crafting a Cohesive Scientific Narrative
    Rather than a mere list of studies, the submission should synthesize data into a clear, expert narrative that connects findings to the product’s regulatory questions, emphasizing consistency, risk-benefit, and clinical relevance.
  5. Address Potential Biases and Gaps
    Proactively discussing limitations, conflicting results, or data gaps head-on increases regulatory confidence and mitigates risk of rejection.
  6. Consistent Quality and Formatting
    Using standardized templates, controlled vocabularies, and checklists ensures editorial consistency and facilitates smooth eCTD submissions.

Maven’s Role in LBS Success

Maven Scientific Laboratories serves as a strategic partner, providing expert regulatory medical writing that bridges scientific data and regulatory expectations. Our services include:

  • Designing rigorous literature search strategies and generating screening logs
  • Drafting clinical overviews, benefit-risk analyses, and regulatory narratives
  • Ensuring alignment with ICH CTD guidelines and agency-specific formats
  • Preparing eCTD-ready modules with meticulous quality control

Our multidisciplinary team collaborates closely with subject matter experts and regulatory affairs teams to deliver compelling, compliant submissions that advance your product lifecycle.

The Competitive Edge of Literature-Based Submissions

Opting for an LBS approach yields several tangible benefits:

  • Faster Time to Market — Avoid lengthy and costly new studies.
  • Cost Efficiency — Maximize use of existing, validated scientific evidence.
  • Broader Data Access — Incorporate diverse, real-world, and historic data points.
  • Regulatory Reliability — Demonstrate transparency and scientific rigor, building trust with regulators.

Conclusion

Literature-Based Submissions are more than just a shortcut; they represent a strategic, scientifically sound pathway to regulatory approval. By skillfully harnessing existing evidence and partnering with expert regulatory writers like Maven, life sciences companies can expedite approvals, reduce costs, and robustly demonstrate product benefits—achieving success in an increasingly demanding global marketplace.