Is Local Language Review Causing Delays in Compliance?

Pharmacovigilance (PV) is the cornerstone of patient safety in the pharmaceutical and life sciences industry. It involves the continuous monitoring, detection, assessment, and prevention of adverse effects or other drug-related problems. With regulatory authorities across the globe tightening the rules for reporting Individual Case Safety Reports (ICSRs), maintaining compliance timelines has never been more critical. However, one persistent challenge that many pharmaceutical companies and Contract Research Organizations (CROs) face is local language review, which can significantly delay regulatory submissions and threaten compliance.

In this blog, we explore why local language review is a bottleneck, its impact on regulatory compliance, and how Tesserblu can help streamline the process.

The Role of Local Language Review in Pharmacovigilance

Pharmacovigilance is a global activity, but regulations are local. Each country has its health authority requirements, including submission timelines, formats, and language mandates. Regulatory agencies such as the European Medicines Agency (EMA) and US FDA require ICSRs to be submitted in a standard format, but many regional authorities also require documents, narratives, and summaries to be reviewed or submitted in their local language.

Key instances where local language review is essential:

1. Adverse Event Narratives: While the primary ICSR may be generated in English, the narrative often must be translated for local authorities to ensure accurate understanding.

   
   

2. Periodic Safety Update Reports (PSURs)/Periodic Benefit-Risk Evaluation Reports (PBRERs): Local health authorities may require summaries in their national language.

   
   

3. Risk Management Plans (RMPs): Country-specific annexes and communications often need local language review.

   
   

4. Labeling and Patient Safety Communications: Local instructions for use, warnings, and safety leaflets require precise translation and approval.

This multilingual requirement is essential for patient safety but can quickly become a time-consuming bottleneck.

Why Local Language Review Causes Delays

The pharmacovigilance process is inherently time-sensitive. For example, serious ICSRs have to be reported to regulatory authorities within 7 to 15 days, depending on the country and type of event. Local language review introduces several challenges:

1. Manual Translation and Review

Most companies rely on human translation teams to convert safety narratives or documents into local languages. This process is:

• Slow, as expert translators and safety reviewers are limited.

• Prone to errors, especially if translators lack medical or pharmacovigilance expertise.

• Resource-heavy, as the same content may require multiple rounds of review to meet accuracy and regulatory standards.

  
  

2. Inconsistent Quality and Terminology

Medical terminology and regulatory language are highly specialized. If translations are inconsistent or inaccurate, it can lead to:

• Queries or rejections from health authorities.

• Delays in case closure and submission.

• Risks of non-compliance if timelines are breached.

  
  

3. Time Zone and Regional Bottlenecks

When safety teams operate globally, local language reviewers often reside in different time zones. Limited reviewer availability can cause:

• Bottlenecks during peak reporting periods.

• Delayed signal detection and aggregate reporting.

  
  

4. Increased Compliance Risk

Regulators impose strict submission timelines for both individual and aggregate reports. Any delay in local language approval can result in:

• Late submissions, leading to regulatory warnings or fines.

• Audit observations or findings during inspections.

• Reputational risk, as delays indicate weak PV operational control.

  
  

Impact on Regulatory Compliance and Business

Delays in local language review have both regulatory and business implications:

1. Missed Timelines for ICSRs: Even a single delay in translation or review can cause late submissions to EudraVigilance, FDA FAERS, or national agencies like ANSM (France) or BfArM (Germany).

2. Increased Operational Costs: Rework due to translation errors or inconsistent medical terminology increases costs for both CROs and pharma companies.

3. Regulatory Penalties and Inspection Risks: Non-compliance can trigger audits, inspection findings, and in some cases, monetary penalties.

4. Strained PV Teams: Teams spend significant time chasing translations, coordinating with local reviewers, and performing quality checks instead of focusing on signal detection or risk management.

The growing volume of ICSRs, especially with the rise in biologics, vaccines, and global clinical trials, further exacerbates these challenges.

Strategies to Overcome Local Language Review Delays

Pharmaceutical companies and CROs can consider several strategies to mitigate delays:

1. Centralized Translation and Review Teams

Creating a centralized pool of trained medical translators can ensure consistent quality, standardized terminology, and quicker turnaround times. However, this requires significant investment and ongoing training.

2. Technology-Enabled Language Solutions

AI-driven translation tools are increasingly being explored in PV operations. These tools:

• Offer rapid first-pass translations.

• Reduce dependency on human translators.

• Can be integrated with case processing workflows for efficiency.

However, AI translations still require human medical review to ensure regulatory compliance and patient safety.

3. Standardization of Terminology

Implementing MedDRA-based glossaries, local language dictionaries, and translation templates can speed up review and minimize inconsistencies.

4. Outsourcing to Specialized Vendors

Partnering with vendors specializing in PV translations and local submissions can reduce operational load. But it requires careful vendor qualification to ensure compliance.

How Tesserblu Can Help?

Tesserblu is transforming how organizations handle local language reviews in pharmacovigilance. Its innovative platform integrates AI-driven translation, workflow automation, and compliance tracking to eliminate common bottlenecks.

Here’s how Tesserbluhelps:

1. Accelerated Translation and Review

• AI-Powered Translation: Tesserblu provides immediate first-pass translations for adverse event narratives, RMPs, and PSURs.

• Medical Context Recognition: Unlike generic translation tools, Tesserblu is built for pharmacovigilance and life sciences, ensuring contextually accurate outputs.

• Built-In Glossary: Integration with MedDRA and local language glossaries ensures consistent terminology.

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2. Integrated Compliance Tracking

• Tracks translation and review timelines to ensure nothing breaches regulatory deadlines.

• Provides real-time alerts for pending reviews, reducing submission delays.

  
  

3. Seamless Workflow Automation

• Automates routing of ICSRs and safety documents to local reviewers.

• Enables parallel processing, reducing wait time caused by time zone differences.

• Facilitates collaboration between global PV teams and local affiliates.

  
  

4. Audit-Ready Documentation

• Maintains traceable records of translations, reviews, and approvals.

• Simplifies regulatory audits and inspections with a centralized log of all local language activities.

By reducing manual translation efforts, improving accuracy, and ensuring timely submission, Tesserblu helps pharmaceutical companies maintain compliance without unnecessary delays or costs.

The Future of Local Language Review in PV

As the pharmacovigilance landscape becomes more globalized and digital, regulatory agencies are also adopting electronic submissions and automated safety reporting. However, local language requirements will continue to exist because patient safety communications must be understandable by local healthcare providers and patients.

The future lies in digitally enabled PV operations, where:

• AI and automation handle routine translation and routing.

• Local reviewers focus only on high-value quality checks.

• Compliance dashboards ensure proactive monitoring of deadlines.

With solutions like Tesserblu, pharmaceutical companies and CROs can transform local language review from a bottleneck to a streamlined, compliance-driven process.

Conclusion

Local language review is an unavoidable aspect of pharmacovigilance, but it is also a critical bottleneck impacting compliance timelines and operational efficiency. Manual processes, inconsistent terminology, and time zone challenges often lead to delayed ICSR submissions and increased regulatory risk.

By leveraging technology-enabled solutions like Tesserblu, organizations can accelerate translations, standardize terminology, and ensure real-time compliance tracking. This not only reduces delays but also allows PV teams to focus on patient safety and strategic risk management, instead of chasing translations.

In the high-stakes world of pharmacovigilance, where every day counts, streamlining local language review is not just operational efficiency—it is a compliance imperative. Book a meeting, if you are interested to discuss more.