Milestone Localization releases a comprehensive handbook on QRD translation compliance for EMA approvals
Milestone Localization, a specialist regulatory translation provider for the life sciences sector, has released a new ebook titled Translating for EMA Approval – The Complete QRD Compliance Handbook. The guide focuses on QRD translation requirements for pharmaceutical companies seeking EU market authorization.
- (1888PressRelease) January 17, 2026 - Milestone Localization, a specialist regulatory translation provider for the life sciences sector, has released a new ebook titled Translating for EMA Approval – The Complete QRD Compliance Handbook. The guide focuses on QRD translation requirements for pharmaceutical companies seeking EU market authorization.
The handbook addresses a core challenge in centralized procedures - delivering QRD-compliant Product Information translations across all EU languages within fixed timelines of 180–235 days. It supports Regulatory Affairs teams working on SmPC, Package Leaflets, and labelling submissions to the European Medicines Agency.
The guide offers practical guidance on translation quality, terminology control, and country-specific requirements, helping teams avoid linguistic review comments and approval delays.
Focus on EMA QRD translation requirements
The EMA’s QRD Template defines mandatory structure, wording, and formatting for Product Information documents submitted through the centralised procedure. Any deviation identified during linguistic review can result in resubmission requests and compressed correction timelines.
What the handbook covers:
The ebook provides practical, implementation-focused guidance across five core areas:
QRD Template translation requirements: Defining exactly which documents require translation and how they must be structured for EMA submissions
Translation quality standards: Measurable criteria including MedDRA terminology usage, glossary management, and error classification
Managing translations for Day 180 compliance: Realistic project timelines, handling source text changes, and preparing for the five-day Day 210–215 window.Country-specific and blue box requirements: Detailed guidance on Member State variations, multi-language markets, and linguistic review focus areas.
Responding to Member State translation questions: Structured response strategies for terminology, readability, blue box content, and technical accuracy comments. The guide is designed as an operational reference for Regulatory Affairs Managers rather than a high-level overview, with clear workflows and examples that reflect actual EMA review practices.
Industry perspective
Commenting on the release, Nikita Agarwal, Founder of Milestone Localization, said:
“Regulatory teams face zero tolerance for translation errors during EMA submissions, yet they work under extreme time pressure and frequent template updates. This handbook translates QRD requirements into clear, actionable guidance so teams can control translation risk instead of reacting to Member State comments.”
Availability
Translating for EMA Approval - The Complete QRD Compliance Handbook is available for free download on Milestone Localization’s website and is intended for pharmaceutical companies planning or actively managing EU centralised procedure submissions. https://www.milestoneloc.com/translating-for-ema-approval-qrd-compliance/
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