What Is a Literature-Based Submission (LBS)?

 A Regulatory Writer’s Guide to LBS

In today’s fast-paced life sciences arena, literature-based submissions (LBS) have emerged as an agile, cost-effective, and scientifically robust route to Regulatory approval. If your organization is looking to optimize resources without compromising scientific rigor, this blog is for you.

What is an LBS—and When Is It Appropriate?

A literature-based submission (LBS) relies primarily—or entirely—on published, peer‑reviewed data, rather than sponsoring proprietary clinical or non‑clinical studies. Regulatory authorities typically allow LBS in scenarios where:

• The active ingredient has a well-established registration history in mature markets (>10 years), with consistent use across countries like the US, UK, Canada, EU, and New Zealand.
• You’re pursuing label expansions, dosage updates, pharmacokinetic/pharmacodynamic changes, or new indications .
• There’s limited—or no—company‑sponsored data to support certain submission modules, particularly non‑clinical (CTD Module 4) and clinical (Module 5).

However, Modules related to product quality (Module 3) typically require your own validated data—not literature . Similarly, updating clinical trial sections almost always needs full study reports, not just published papers.

Best Practices for a Successful LBS

1. Plan ahead & consult early
   Engage regulators (e.g., TGA’s OMA case manager) at least 3 months before submission to align on methodology and expectations.
2. Craft a sound search strategy
   Go beyond PubMed—tap into EMBASE, Cochrane, Web of Science, and field-specific sources. Use PICO frameworks, anticipate synonyms/trade names/CAS numbers .
3. Transparency is key
   Document every step: search syntax, screening logs, full-text retrievals, quality appraisals (e.g., GRADE or CASP), and reasons for exclusion.
4. Curate a scientific narrative
   Develop expert overview sections (e.g., CTD Module 1.4) that synthesize findings—not just list studies. Subject-matter experts lend credibility.
5. Address biases proactively
   Acknowledge gaps, handle conflicting data thoughtfully, and guard against cherry-picking.
6. Consistent style & QC standards
   Unified formatting via style guides/lexicons makes dossiers easier to review, reduces RTF risk, and reflects professionalism certara.com.

The Regulatory Writer’s Role

As the bridge between science and regulators, a skilled Regulatory medical writer:

• Shapes the storyline: Converts raw data into a persuasive, accessible narrative.
• Ensures compliance: Aligns with ICH, CTD, TGA, EMA, FDA formatting and style rules.
• Coordinates across teams: Collaborates with SMEs, librarians, Regulatory affairs, quality, and publishing.
• Implements quality controls: peer reviews, formatting checks, cross-referencing, and eCTD-publishing readiness.

This holistic approach ensures that submissions don’t just check Regulatory boxes—they communicate clearly and strengthen credibility.

The Competitive Edge: When LBS Makes Sense

• Faster time-to-market: No new trials = quicker submissions.
• Optimized budgets: Reduced cost compared to de novo studies.
• Wider evidence base: Access to global, real-world, and historical data.
• Regulator-friendly: When well-executed, LBS demonstrates transparency, integrity, and scientific robustness.

Literature-based submissions, when crafted properly, offer a strategic advantage in today’s Regulatory environment. But success demands structure, transparency, scientific acumen, and meticulous execution.

As a global provider of Regulatory medical writing services, we help life sciences and pharma organizations navigate the complexities of LBS freelancing or outsourcing—from search strategy development and expert write-up drafting to dossier formatting and submission-readiness. Let us strengthen your Regulatory path and accelerate your product’s lifecycle—all while showcasing your scientific excellence.