How many patients are needed for PIL readability testing per language?

EMA guidance recommends testing with a minimum of 10 individuals per language, though 20 is more typical for key languages. The test participants should be lay people who represent the intended patient population — not healthcare professionals. You must demonstrate that at least 90% of participants can find the relevant information and understand how to act on it. If your first round doesn't meet the threshold, you revise and retest.

Can the same PIL template be translated into all 24 languages without major adaptation?

The structure can be consistent across all 24 — EMA specifies the required headings and content order, which don't change by language. But the language itself requires meaningful localization, not just translation. Readability conventions differ by language, health literacy levels vary across EU populations, and some concepts that are expressed efficiently in English require different framing in other languages to be equally clear. A direct translation of the English structure is a starting point, not a finished product.

How do label variations between member states affect translation requirements?

For centralized procedure authorizations, the core Product Information is standardized across all member states — the same SmPC, same PIL structure, same approved indications. Member states may add national-level information (like local contact numbers) to the labeling, but the core content doesn't vary. For decentralized or national authorizations, the requirements vary by country — you may have 27 different versions of the Product Information rather than one centralized version. Decentralized procedures multiply the translation complexity significantly.

Global

Translating Drug Information into 24 EU Languages — What EMA's Requirements Actually Mean in Practice

EMA marketing authorization requires patient-facing materials in all 24 EU official languages. The translation isn't the hard part — the readability requirement is. Here's what that means for your submission.

TL;DR — Key Takeaways

1.EMA's centralized procedure marketing authorization requires the Product Information (SmPC, labeling, and Patient Information Leaflet) to be provided in all 24 EU official languages.
2.The Patient Information Leaflet (PIL) must pass user testing — EMA requires evidence that real patients, without medical training, can understand and act on the information correctly.
3.Translation quality for the PIL isn't evaluated by linguistic accuracy alone — it's evaluated by whether patients who read it can answer key safety questions correctly.
4.24 languages means 24 translation projects, but it doesn't mean 24 separate workflows — a consistent termbase and structured process can handle the volume efficiently.

What EMA's Language Requirements Actually Cover

The EMA's centralized procedure applies to medicines that require EU-wide authorization — typically medicines for serious diseases, new active substances, and biotechnology products. For these, the Product Information — Summary of Product Characteristics (SmPC) for healthcare professionals, the labeling, and the Package Leaflet (PIL) for patients — must be provided in all 24 official EU languages: Bulgarian, Croatian, Czech, Danish, Dutch, English, Estonian, Finnish, French, German, Greek, Hungarian, Irish, Italian, Latvian, Lithuanian, Maltese, Polish, Portuguese, Romanian, Slovak, Slovenian, Spanish, and Swedish.

The SmPC and labeling are primarily used by healthcare professionals and pharmacists, so they're evaluated primarily on linguistic and terminological accuracy. The PIL is different. It's designed to be read and acted on by patients who may have no medical training, may be managing a serious condition, and may be making dosing decisions based on what it says.

This is why EMA evaluates the PIL differently from other product information documents. It's not enough for the PIL to be linguistically accurate — it must be comprehensible and actionable for the patient population of each member state in their native language.

The Readability Test — Why Language Accuracy Isn't Enough

EMA guidance requires readability testing for the PIL as part of the marketing authorization application. The standard approach involves testing the PIL with a sample of target users — typically 10–20 lay people without medical training in each language — and demonstrating that they can correctly answer a defined set of questions about the medicine's use, dosage, side effects, and contraindications.

A PIL that is technically accurate but uses complex medical terminology will fail readability testing. A PIL that uses simple language but is ambiguous about dosing instructions will also fail. The EMA's standard is functional comprehension, not just linguistic correctness — can the patient actually do what the PIL instructs them to do?

This creates a different translation requirement than most pharmaceutical documents. The translator must not only be accurate — they must actively simplify, use lay terminology where available, and structure instructions in a way that supports action. This is more demanding than translating SmPC text, and it requires reviewers who can evaluate comprehension, not just accuracy.

The Challenge of Less-Resourced EU Languages

24 EU official languages includes languages with limited pharmaceutical translation resources: Maltese, Irish, and some of the smaller Central and Eastern European languages have fewer qualified pharmaceutical translators and less developed translation memory resources than major languages like French, German, and Spanish.

For these languages, translation quality assurance is harder to verify. Fewer pharmaceutical LSPs (Language Service Providers) specialize in them, fewer in-country pharmaceutical regulators review the translations before submission, and the available translation memory resources are thinner. This creates higher variability in translation quality across the 24 required languages.

The practical response is to invest more QA resources proportionally for the less-resourced languages. A French PIL with an error will be caught by the large pool of French pharmaceutical reviewers; a Maltese PIL with an equivalent error has fewer reviewers to catch it. Additional review steps for languages with limited specialist resources reduce the risk of a gap in one language requiring re-submission.

Managing 24-Language Translation Efficiently

The key to managing 24-language translation at reasonable cost is front-loading: all terminology decisions, regulatory term mappings, and structural requirements should be resolved in English before translation begins. Revisions in English are cheap; revisions in 24 languages simultaneously are expensive. A clean, final English source document with resolved terminology reduces the compounding cost of changes across all language versions.

AI translation with a pharmaceutical-specific termbase and style guide can efficiently handle the first pass for all 24 languages, producing drafts that qualified reviewers then evaluate for regulatory compliance and readability. The reviewer's job is focused on what AI can't evaluate: whether the language reads naturally for the target population, whether the dosing instructions are unambiguous, and whether the safety information is appropriately prominent.

For post-approval label changes — which pharmaceutical products require regularly throughout their lifecycle — a consistent translation workflow with maintained termbases means that label changes can be propagated across all 24 languages with consistency and auditability. The investment in building the infrastructure pays dividends over the product's entire approved lifecycle.

Frequently Asked Questions

Get expert-level translation without the expert cost

43 AI agents run the full professional translation workflow — analysis, terminology, translation, review, QA — starting at $0.01/word.

Try it free