From SmPC to EMA Approval: 5 Steps to Risk-Free Pharmaceutical Translation

In the European regulatory environment, precision is not just a matter of linguistic quality—it is a compliance requirement. An error in the translation of a Summary of Product Characteristics (SmPC), Patient Information Leaflet (PIL), or labelling can trigger requests for clarification during the review process by the European Medicines Agency, directly impacting approval timelines and market access. 

For Regulatory Affairs teams, translation cannot remain a bottleneck. It must be a controlled, traceable process aligned with EMA standards from the very first submission. 

Below, we outline the five critical steps to ensure your multilingual documentation successfully passes regulatory scrutiny across Europe.

1. Strict alignment with QRD templates 

In European procedures, product information (SmPC, PIL and labelling) must comply with the QRD (Quality Review of Documents) templates published by the EMA. 

Why it matters: 

QRD templates define not only format, but also structure, headings, and standard wording. Any deviation may lead to comments during the linguistic review phase following a positive CHMP opinion. 

The Lexic approach: 

We work directly with the latest QRD templates across all required EU languages, ensuring structural consistency and compliance from the outset.

2. Multilingual consistency and version control 

A centrally authorised product must present consistent information across up to 24 official EU languages. Lack of alignment between language versions is one of the most common risks in the final stages of the procedure. 

Common risks: 

• Discrepancies between SmPC, PIL and labelling 

• Inconsistencies across language versions 

• Errors introduced during post-approval variations 

Best practices: 

• Product-specific translation memories 

• Validated regulatory glossaries 

• Version control aligned with eCTD structure 

This ensures that any future updates (variations) remain fully consistent with previously approved content. 

3. Terminological accuracy in pharmacovigilance 

In the EMA context, terminology is not just technical—it is regulatory. 

Critical example: 

The distinction between serious and severe is essential: 

• Serious adverse event → adverse event classified as ‘serious’ (regulatory definition) 

• Severe → refers to intensity 

Incorrect usage may lead to inconsistencies with pharmacovigilance databases based on MedDRA (Medical Dictionary for Regulatory Activities). 

The Lexic approach: 

Our linguists specialise in Life Sciences, with proven experience in EMA regulatory documentation and validated terminology management. 

4. Review process in line with ISO 17100 

The EMA expects a level of quality that eliminates ambiguity in information provided to both patients and healthcare professionals.

A robust process should include: 

• Translation by a native Life Sciences specialist 

• Independent revision by a second qualified linguist 

• Final quality assurance (QA) to verify completeness, formatting and QRD compliance 

This workflow, aligned with ISO 17100, significantly reduces the risk of comments during the linguistic review phase. 

5. Preparation for the EMA linguistic review phase 

Following a positive CHMP opinion, product information undergoes a linguistic review coordinated by the EMA in collaboration with Member States. 

What this involves: 

• Validation of all language versions 

• Review by national competent authorities 

• Identification of inconsistencies or QRD deviations 

Key to success: 

Submitting translations that are already aligned with regulatory expectations, thereby avoiding additional revision cycles that may delay the final decision.

The Lexic approach: 

We prepare documentation to pass this phase smoothly, anticipating the criteria applied by European reviewers.

Comparison: Generalist agency vs EMA-specialised partner 

 Preparing for an EMA approval? 

The linguistic phase should not be the weakest point in your centralised procedure. 

At Lexic, we help Regulatory Affairs teams turn multilingual complexity into a controlled, predictable process aligned with EMA standards. 

Accelerate your approval with documentation ready to pass European review. 🚀