Louvain concentrates an exceptional density of biomedical research: the UZ Leuven(more than 2,000 beds), the KU Leuven (world top 50 in medicine), the Rega Institute (antivirals of world reference) and UCB Pharma. Medical translation in Louvain operates at the boundary between the clinic, fundamental research and global pharmaceutical regulation - PCT patents, IND dossiers for the FDA, IMPD for the EMA and Phase I/II/III trial protocols.
Louvain, world capital of biomedical research
The UZ Leuven, with its Gasthuisberg and Sint-Pieter campuses, is one of the largest hospitals in Europe by number of beds and volume of surgical activity. Its liver transplantation, oncology and interventional cardiology departments welcome patients from all over Belgium and abroad. In parallel, the UZ Leuven is one of the most active clinical trial centres in Belgium: it participates in several hundred clinical studies simultaneously, covering phases I to III for innovative medicines, gene therapies and next-generation medical devices.
The KU Leuven, ranked among the 50 best universities in the world in medicine, generates a continuous flow of scientific publications, patent dossiers and technology licensing contracts. Its technology transfer office, the LRD (Leuven Research & Development), regularly negotiates licences with pharmaceutical giants such as UCB, Johnson & Johnson, Pfizer and Sanofi. These contracts, often drafted in English, must sometimes be translated into Dutch for Belgian legal obligations or into other languages for the Asian or American partners.
The Rega Institute for Medical Research, attached to the KU Leuven, is world renowned for its work on antivirals. The Rega researchers have developed anti-HIV and anti-herpes molecules that have become reference medicines. Their publications, their research protocols and their patent applications constitute a considerable volume of scientific texts of very high technicality, requiring translators who master virology, pharmacokinetics and molecular biology.
UCB Pharma, whose global headquarters is in Brussels but a large part of whose R&D is conducted in Louvain and in the Mechelen region (with Galapagos), focuses on rare diseases, epilepsy and autoimmune diseases. The MA dossiers, the Clinical Study Reports and the reports of the DSMB (Data Safety Monitoring Board) that accompany their clinical trials represent tens of thousands of pages to translate for each EMA or FDA procedure.
Types of documents translated in the Louvain ecosystem
- Phase I/II/III clinical trial protocols: complete translation of the protocols for the UZ Leuven and the associated DSMBs, including the statistical analysis plan, the investigator's brochure and the amendments, into English, French or the languages of the international co-investigators
- Pharmaceutical and medical patents (PCT, EP): translation of the claims, the description and the drawings for the PCT (Patent Cooperation Treaty) and EP dossiers filed by the LRD/KU Leuven, notably for the Chinese, Japanese, American and Korean markets
- Technology licensing contracts: translation of the term sheets, the exclusive and non-exclusive licence contracts and the co-development agreements concluded between the LRD and global industrial partners such as UCB, Johnson & Johnson or Pfizer
- Regulatory IND and IMPD dossiers: translation of the Investigational New Drug applications (IND) for the American FDA and the Investigational Medicinal Product Dossiers (IMPD) for the EMA, including the preclinical, toxicological and pharmaceutical data
- Publications of the Rega Institute: translation and linguistic revision of the scientific articles in virology and antivirals for the peer-reviewed journals, from English into Dutch or French for local communications
- Multilingual DSMB reports and informed consent forms: for the international multicentre trials, translation of the reports of the Data Safety Monitoring Board and the informed consent forms in more than 20 languages, covering all participating sites in Europe, Asia and Africa
TranslateBE
Medical and regulatory translation in Louvain
Specialised translators for the UZ Leuven, the KU Leuven, the Rega Institute and UCB Pharma. PCT patents, EMA/FDA dossiers, clinical trial protocols and licensing contracts.
Regulatory requirements: ICH, EMA, FDA and AFMPS
The clinical trials conducted at the UZ Leuven fall within the framework of the good clinical practices (GCP) defined by the ICH E6(R2) guideline. This guideline imposes precise requirements on the documentation of the trials, including on the quality and the traceability of the translations. The informed consent forms must be drafted in language accessible to the participant and validated by the local ethics committee. For international multicentre trials, each language version of the consent must be validated separately.
The IND (Investigational New Drug) dossiers submitted to the American FDAfor molecules developed at the Rega Institute or by UCB must be entirely in English. On the other hand, when the same molecule is the subject of an IMPD dossier for a clinical trial authorisation by the EMA or by the AFMPS in Belgium, specific sections may require a translation into Dutch or French. The navigation between the FDA and EMA requirements requires in-depth knowledge of the two regulatory systems, which our specialised pharmaceutical translators possess.
For patents, the European unitary patent system which came into force in June 2023 modified the translation obligations. The patent applications are now filed in English, French or German with the EPO, without a systematic obligation to translate into all the EU languages. However, for the markets outside the EU - China, Japan, Korea, United States - the national or regional filings require certified translations in the language of the country concerned. The LRD of the KU Leuven regularly entrusts this type of translation to agencies specialised in pharmaceutical intellectual property.
Indicative timelines and rates for medical translations in Louvain
| Type of medical document | Indicative rate | Timeline |
|---|---|---|
| Complete clinical trial protocol (with annexes) | On quote | 7-15 days |
| Pharmaceutical patent (per page) | 55-80 €/page | 5-10 days |
| Technology licensing contract | 0,14 €/word | 5-7 days |
| Complete regulatory IMPD / IND dossier | On quote | 10-20 days |
| Multilingual informed consent (20+ languages) | 0,13 €/word/language | 3-7 days |
For large-scale multilingual projects - informed consent forms in 20 languages or complete IMPD dossiers - we form teams of pharmaceutical translators dedicated to the project, with a single project manager and a shared terminology glossary to guarantee consistency between the language versions. Project management is included in the quote. VAT not applicable (art. 44 §3 Belgian VAT Code).
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Your medical translation in Louvain within 24h
From the KU Leuven patent to the multilingual informed consent for the UZ Leuven - our pharmaceutical translators master the ICH, EMA and FDA requirements for the most complex projects.
FAQ
Frequently asked questions
Does the UZ Leuven require an ICH E6 certification for the translators of clinical trial protocols?
The ICH E6(R2) guideline on good clinical practice does not define a specific certification for translators, but requires that all translations be accurate and verifiable. In practice, the ethics committees of the UZ Leuven and the trial sponsors require that translators have medical or pharmaceutical training, documented experience in clinical trials and sign confidentiality agreements. We systematically provide a translator CV and a certificate of experience in clinical trials on request.
How do I translate a KU Leuven pharmaceutical patent for filing in China and Japan?
The translation of a pharmaceutical patent for China (CNIPA) and Japan (JPO) is a highly technical exercise. In China, the translation into simplified Mandarin must comply with the chemical terminology standardised by the Chinese pharmacopoeia and the drafting practices specific to patent claims. In Japan, the translation into Japanese must follow the very formalised stylistic conventions of Japanese patent claims. Our translators specialised in pharmaceutical intellectual property work in tandem with native patent engineers for these markets, guaranteeing claims that are defensible before the national offices.
Does UCB Pharma use external translators for its EMA dossiers?
Like the majority of large pharmaceutical companies, UCB Pharma outsources a significant part of its regulatory translations to specialised agencies. The volumes of a complete MA dossier (several tens of thousands of pages in 24 EU languages) exceed the capacities of the internal teams. The partner agencies must demonstrate their experience in pharmaceutical regulation (ICH, EMA, CTD), have translation memories for UCB terminology and comply with ISO 17100 quality processes. We work for actors in this sector with dedicated glossaries and stable project teams.
What is the difference between medical translation and regulatory pharmaceutical translation?
Medical translation covers the clinical documents arising from medical practice: patient records, operative reports, discharge letters, informed consent forms in the clinical sense. It requires training in medicine or nursing and a command of anatomy and nosology. Regulatory pharmaceutical translation deals with the documents of the life cycle of a medicine: MA dossiers, CTD modules, SmPCs, IMPD, clinical study reports, patents. It requires knowledge of European pharmaceutical law (EMA, AFMPS), the ICH guidelines and the CTD/eCTD submission formats. At the UZ Leuven and in the Louvain ecosystem, these two types of translation often coexist within the same clinical trial project.