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🧪 How Inaccurate Translations Can Delay Pharma Product Approvals.Â
🧪 How Inaccurate Translations Can Delay Pharma Product Approvals.Â
March 8, 2021
In the pharmaceutical world, every word matters.
A single mistranslation in labeling, packaging, or regulatory documentation can cause costly setbacks — and in some cases, full rejections from health authorities.
1. Regulatory Non-Compliance
1. Regulatory Non-Compliance
Health agencies like the FDA, EMA, and Health Canada require precise terminology in submissions, patient leaflets, and IFUs. Even minor language errors can trigger requests for clarification or re-submission, delaying approvals by weeks or months.
2. Misaligned Terminology
2. Misaligned Terminology
Each country has its own approved medical vocabulary and abbreviations. When translations aren’t handled by subject-matter experts, inconsistent terms can appear across documents — raising red flags during review.
3. Labeling & Packaging Risks
3. Labeling & Packaging Risks
Incorrect dosage units or warnings on packaging can lead to product recalls or halted launches. Consistent, accurate translations ensure patient safety and compliance from the start.
The takeaway:
Professional translation in the Pharmaceutical industry isn’t just about words — it’s about patient safety. At WeTranslate, we combine native-language precision with industry expertise to help life-science companies communicate clearly across markets.
📦 3 Ways to Make Your Packaging Compliant Across Markets
📦 3 Ways to Make Your Packaging Compliant Across Markets
November 9, 2023
Expanding internationally? Before you print that next batch of product packaging, make sure your translations meet local market and regulatory standards. Here are three key steps to keep your packaging globally compliant:
1. Localize, Don’t Just Translate
1. Localize, Don’t Just Translate
Different countries require specific terminology, symbols, and layout rules. Localizing your packaging ensures your message fits both linguistically and culturally — not just word-for-word.
2. Validate with Native Reviewers
2. Validate with Native Reviewers
Always have a native-speaking linguist review final packaging proofs before printing. They’ll catch context issues, measurement errors, and cultural nuances that automated tools miss.
3. Stay Ahead of Regulatory Updates
3. Stay Ahead of Regulatory Updates
Labeling laws change frequently — from ingredient listings to recycling icons. Partner with translation teams familiar with your target region’s current compliance standards to avoid last-minute redesigns.
Packaging is the first impression your brand makes abroad. With WeTranslate’s accurate, localized translations, your packaging stays fully compliant and culturally aligned — helping your products earn trust and recognition in every market.
🌍 Harmonizing Multilingual Labeling During MAA Lifecycle Management
🌍 Harmonizing Multilingual Labeling During MAA Lifecycle Management
June 2, 2023
MAA Labeling Translation & Lifecycle Management | WeTranslate
During the Marketing Authorization Application (MAA) lifecycle, labeling updates are continuous — variations, renewals, and new indications all trigger changes across multiple languages. The challenge is ensuring alignment across all markets, especially when each Health Authority may require unique phrasing or formatting.
Consistency failures can delay renewals or trigger Health Authority queries. That’s why a strong translation management and version control process is crucial.
At WeTranslate, we harmonize multilingual labeling by maintaining master terminology databases, version-controlled translation memories, and cross-market reconciliation tools. This allows our clients to update 20+ language versions simultaneously — ensuring every update remains compliant, consistent, and traceable throughout the MAA lifecycle.
⚙️ Why Translation Validation Should Be Part of Your Quality Management System (QMS)
⚙️ Why Translation Validation Should Be Part of Your Quality Management System (QMS)
December 8, 2024
Translation Validation & QMS Compliance | WeTranslate
In a GMP or ISO 13485 environment, every controlled document must be validated for accuracy — including translations. Yet, many manufacturers overlook language validation within their Quality Management System (QMS).
Translation validation ensures that critical content—such as IFUs, SOPs, and labeling—is accurately rendered and verified by qualified linguists. Without this step, discrepancies between the source and translated versions can lead to compliance gaps or audit findings.
WeTranslate integrates translation validation directly into our QMS-aligned workflows. Every translation undergoes independent review, back-translation (where required), and QA traceability, providing full audit trails and linguistic certificates of accuracy — so your documentation meets ISO and GMP standards every time.
đź’Š Implementing Back-Translation for Pharmacovigilance Documents: When and Why It Matters
đź’Š Implementing Back-Translation for Pharmacovigilance Documents: When and Why It Matters
February 12, 2025
Pharmacovigilance (PV) content — such as Patient Information Leaflets (PILs), Risk Management Plans (RMPs), or safety communications — demands the highest linguistic precision. In such cases, back-translation becomes a key validation step.
Back-translation involves re-translating the target text back into the source language to identify discrepancies or shifts in meaning. It’s particularly valuable for patient-facing content, informed consent forms, and adverse event reports, where misinterpretation could compromise safety.
At WeTranslate, we implement structured back-translation workflows using two independent linguists, followed by a comparative analysis and reconciliation report. This ensures that every PV translation is not only accurate but validated for both regulatory and ethical compliance.
🇨🇦 Bridging Labeling Updates Between EMA QRD Templates and Health Canada Formats
🇨🇦 Bridging Labeling Updates Between EMA QRD Templates and Health Canada Formats
July 3, 2025
While both EMA and Health Canada require product information in standardized templates, their terminology, structure, and regulatory phrasing differ significantly. Maintaining consistency across both regions is one of the biggest challenges in multilingual labeling.
Phrases accepted in the EU’s QRD template may need adaptation to align with Health Canada’s monograph style and bilingual (English/French) requirements. Misalignment between the two can lead to approval delays or additional queries.
At WeTranslate, we specialize in cross-agency harmonization, ensuring every update aligns with each region’s expectations. Our translators are trained in both EMA QRD and Health Canada formatting, guaranteeing consistent tone, layout, and compliance across your international submissions.
⚕️ The Role of Controlled Terminology in Medical Device IFU Translations (ISO 15223-1 & MDR Requirements)
⚕️ The Role of Controlled Terminology in Medical Device IFU Translations (ISO 15223-1 & MDR Requirements)
Augusr 25, 2025
Medical device labeling must follow precise, regulated terminology defined by ISO 15223-1, MDR Annex I, and IMDRF guidelines. Translators can’t simply choose synonyms — they must use controlled terminology that matches regulatory expectations.
Challenges often arise when terms like “sterile barrier system” or “non-pyrogenic” have no direct linguistic equivalent, or when symbols must be aligned with textual descriptors.
WeTranslate leverages a centralized terminology management system built specifically for medical device translations. Our linguists cross-reference ISO terms, UDI data, and IFU context to ensure every translation reflects the correct regulated meaning — reducing audit risk and ensuring device safety documentation is fully compliant worldwide.
🧾 What Is SPL (Structured Product Labeling)?
🧾 What Is SPL (Structured Product Labeling)?
October 17, 2025
Structured Product Labeling (SPL) is an FDA and Health Canada–approved XML-based format used to submit and exchange product information about drugs, biologics, and medical devices.
It was created to standardize how labeling data is stored, shared, and updated across systems and markets.
Instead of submitting a plain Word or PDF label, companies submit an XML file that includes:
All product information (name, dosage, indications, warnings, etc.)
The structure of the data (tags and attributes that define what each section means)
Linked assets (like logos, barcodes, and package inserts)
That’s a tiny piece of what a structured label looks like —it’s machine-readable and standardized so it can be used across regulatory systems like:
FDA’s DailyMed (for approved drug labeling in the U.S.)
Health Canada’s Drug Product Database
EMA’s ePI framework (Electronic Product Information)
đź’¬ Why SPL Translation Is So Complex
đź’¬ Why SPL Translation Is So Complex
Unlike a normal document, SPL isn’t just text. It’s data + language + structure.
That means when you translate, you’re working inside a coded file where the tags (like <title> or <text>) must remain perfectly intact.
Here are the main challenges:
Tag Integrity – If a translator accidentally edits or deletes a tag, the XML file can “break,” causing submission errors.
Text Limitations – Some fields have strict character limits (e.g., headings). Translations need to be precise but fit within those limits.
Regulatory Phrasing – Each region’s authority uses specific standard language (e.g., EMA QRD templates vs. FDA structured headings).
Version Control – Every update must stay aligned across all languages and versions to maintain data traceability.
This makes SPL translation part linguistic expertise, part data engineering, and part regulatory compliance.
At WeTranslate, we combine linguistic precision with technical accuracy to deliver compliant, submission-ready SPL translations.
Our process ensures your multilingual product labeling remains consistent, validated, and regulator-approved.
1. XML-Safe Translation Tools
We use CAT tools that protect XML tags while allowing translators to focus on the content. This prevents formatting errors and maintains structural integrity throughout the translation.
2. Regulatory Terminology Management
Our linguists specialize in life-science terminology and maintain controlled glossaries aligned with FDA, EMA, and Health Canada standards. This ensures consistent, compliant language across every label version and region.
3. Two-Layer Quality Assurance
Each SPL translation undergoes:
Linguistic review by a second subject-matter expert
XML validation to ensure file structure, encoding, and tags remain submission-ready
4. Collaboration with Regulatory Teams
We partner directly with Regulatory Operations and Labeling departments to align translations with submission templates, QRD requirements, and Health Authority feedback.
5. Secure File Handling
All SPL files are processed under strict confidentiality and version control, with encryption and audit-ready documentation to support your internal quality systems.
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