REVIEW RESPONSIBILITIES
Limitations
RegLens operates as an early-stage automated creative review tool for pharmaceutical and healthcare advertising, but it carries several built-in compliance and technical limitations.
1. Legal and Regulatory Scope Limitations
- Pre-Screening Only (No Legal Guarantee)
- As explicitly stated in its platform disclaimer, RegLens functions strictly as an AI pre-screen. It does not provide legal advice, nor does it guarantee regulatory clearance or immunity from regulatory enforcement actions.
- Non-Replacement of MLR/PRC Teams
- It cannot substitute for formal internal Medical, Legal, and Regulatory (MLR) or Promotional Review Committee (PRC) sign-offs. Final creative approval must still proceed through qualified regulatory and legal professionals.
- Jurisdictional Nuances
- While it supports seven global markets (India, US, UK, EU, UAE, Japan, Australia), local enforcement interpretations vary widely (e.g., FDA OPDP untitled/warning letters vs. UK ABPI Code or CDSCO/ASCI directives in India). AI screening may miss nuanced, evolving case law, localized guidelines, or unpublished regulatory enforcement trends.
2. Technical & Input Constraints
- Format & File Size Caps
- The auditor is restricted to static image formats (PNG, JPG, or WEBP) with a maximum file size of 15 MB. It does not support native video, animated banners (HTML5/GIF), audio scripts, or dynamic interactive web formats.
- Static Context Gaps
- If critical context (such as therapeutic indication, patient population, fair balance disclosures, or mandatory black-box warnings) is spread across multiple slides, linked references, or landing pages, single-asset image audits may flag false positives or fail to detect omitted mandatory risk information.
- AI Hallucinations and False Assumptions
- Generative/vision AI models can misinterpret layout hierarchy, subtle disclaimers, or technical medical phraseology, leading to false negatives (failing to catch subtle unsubstantiated efficacy claims) or false positives (over-flagging compliant clinical wording).