Can AI be trusted with EMA-compliant medical translations?

The life sciences landscape is rapidly transforming as artificial intelligence becomes more integrated into multilingual content processes. With stricter regulatory timelines, an increasing number of required languages, and escalating documentation demands, many clinical, regulatory, and quality professionals are asking: 

Is AI-assisted translation a viable option for regulated medical materials such as SmPCs, patient leaflets, and other documentation required under EMA or MDR/IVDR frameworks, including IFUs and patient-facing communications? 

This article examines the responsible use of AI within compliance-driven environments, and the conditions that make it a reliable solution for medical document translation. 

How AI is changing regulated translation workflows 

AI-enhanced translation technologies have seen considerable advancement recently. When used correctly, they can enhance efficiency, consistency, and scale across various applications, such as: 

• Submissions under centralised EMA procedures in all EU official languages 

• Rapid updates to Instructions for Use (IFUs) and product leaflets 

• Clinical trial materials for multinational research 

These advantages make AI an appealing solution for projects with tight deadlines and large content volumes. Still, regulatory content calls for more than speed, it demands meticulous accuracy, traceability, and strict adherence to terminology and formatting as set by authorities like the EMA, FDA, and others. 

Why AI on its own falls short 

While AI holds great promise, it still struggles with the intricacies of certified medical document translation in specialised fields. Key issues include: 

• Linguistic complexity in languages such as Greek or Finnish 

• Compliance with regulated vocabularies like MedDRA, EDQM, and EMA QRD templates 

• Nuanced wording essential for patient comprehension 

For these reasons, unedited AI output is unsuitable for regulatory use. Quality assurance, compliance, and patient safety can only be maintained through the involvement of expert human reviewers. 

The human element: ensuring safe AI-supported translation 

AI can play a supporting role in translation workflows, but only under the close oversight of trained professionals. In regulated environments, human experts do far more than post-edit: 

• They confirm proper use of regulatory templates and terms 

• They ensure consistency with existing product data and previous filings 

• They evaluate tone, clarity, and patient-friendliness of content 

• They offer the accountability necessary for compliance 

This “human-in-the-loop” method enables the benefits of AI while maintaining the high standards required for translation services for medical offices and regulated industries. Human reviewers function as quality gatekeepers, not just editors. 

Beyond tools: creating compliant AI systems 

Adopting AI in regulatory translation requires more than simply selecting software. The entire workflow must be compliance-ready from the outset. Best practices include: 

• Testing AI models across different languages, content types, and fields 

• Syncing AI output with existing translation memories, termbases, and approved glossaries 

• Defining internal guidelines for AI use depending on content sensitivity 

Such systems reduce the need for extensive post-editing while preserving alignment with regulatory terminology and standards. 

Ensuring EMA compliance through standards and oversight 

Although the EMA hasn’t released AI-specific translation guidance, current regulations offer a clear path forward. AI-assisted processes are permissible when accompanied by thorough human review, transparent workflows, and secure data handling. 

Key industry standards include: 

• ISO 18587 for post-editing machine translations 

• ISO 13485 for quality systems in medical device translation services 

• MDR/IVDR guidance for clarity and consistent language in IFUs and patient documents 

Responsible organisations embed these standards into their clinical research management processes, pairing automation with human validation and ongoing quality control. 

Where regulations stand on AI in translation 

So far, no EU law forbids AI in medical record translation or other regulated workflows. EMA and national authorities prioritise the accuracy and compliance of the final output, regardless of how it’s produced. Key regulatory requirements include: 

• Review by qualified human translators 

• Clear traceability of tools that are used 

• Consistent terminology referencing official sources 

• Transparency and data privacy safeguards 

When these principles are upheld, AI can safely contribute to pharma translation services and regulatory compliance. 

Conclusion 

AI is not a substitute for human knowledge, it’s a tool that, when applied responsibly, can increase the efficiency, accuracy, and scalability of certified language translation services. For regulated medical content, the key lies in merging intelligent automation with human oversight, quality-driven systems, and adherence to global standards. 

As healthcare and pharmaceutical sectors evolve, AI’s role in multilingual communication will continue to expand. But in the realm of regulated translation, one thing remains clear: compliance begins with strong systems, not just software.