Brussels concentrates the European Union's key pharmaceutical decision-making bodies - DG SANTE, EFPIA, EuropaBio - and hosts the representative offices of the world's largest pharmaceutical groups. Regulatory translation is a daily strategic challenge for regulatory affairs and European lobbying teams based in the Belgian capital.
DG SANTE and European pharmaceutical regulation
The Directorate-General for Health and Food Safety (DG SANTE) of the European Commission is based in Brussels. It steers EU pharmaceutical policy, coordinates centralised authorisation procedures with the EMA, and develops revisions to medicinal product directives and regulations.
Pharmaceutical companies with regulatory affairs teams in Brussels produce a large volume of documents requiring precise translation: submissions to the Commission, responses to public consultations, position papers for European institutions, and market access dossiers. These documents demand a perfect command of European regulatory jargon in English, French, German and Dutch.
- Position papers and responses to DG SANTE consultations: technical translation into all official EU languages
- Market access dossiers (HTA): health-economic assessments for Belgian and European bodies
- Communications for EFPIA and EuropaBio: sector reports, impact studies, position papers for Brussels decision-makers
- Documents for EMA centralised procedures: although the EMA is in Amsterdam, its procedures involve many Brussels-based actors
Pharma tenders and translation in Brussels
The European Commission and decentralised agencies regularly publish tenders for pharmaceutical and scientific translation services. Tendering companies must produce precisely translated application documents respecting the official terminology of the institutions.
Beyond institutional tenders, CRMOs (Contract Research and Manufacturing Organisations) and CROs (Contract Research Organisations) operating in the Brussels region have ongoing needs for the translation of clinical protocols, study reports and quality documents. TranslateBE supports these actors with teams specialised in clinical research and European pharmaceutical regulation.
TranslateBE
Pharmaceutical translation in Brussels
Specialists in DG SANTE, EFPIA and EMA procedures. Regulatory translation in 24 to 72 hours for your Brussels dossiers.
Rates for pharmaceutical translation in Brussels
Regulatory pharmaceutical translation for Brussels institutions is priced according to the terminological complexity and format requirements of the destination documents.
- Position papers: from €200 for 2,000 words, delivery in 2 to 4 business days
- Responses to public consultations: bespoke quote based on volume, express delivery possible within 48 hours
- HTA dossiers (health technology assessment): personalised quote based on volume and required language pairs
- Multilingual translation for EU submissions: multilingual project management covering up to 24 official EU languages
FAQ
Frequently asked questions
Is the EMA based in Brussels or in Amsterdam?
The European Medicines Agency (EMA) has its main headquarters in Amsterdam since 2019, after Brexit forced it to leave London. However, many pharmaceutical actors working with the EMA maintain their regulatory affairs teams in Brussels, primarily due to proximity to the European Commission and the European Parliament. EMA centralised procedures involve submissions in English, but national documents still need to be translated into the languages of member states.
Which DG SANTE documents require professional translation?
Documents submitted to DG SANTE in connection with public consultations, centralised MA procedures and regulatory revisions must be absolutely precise. These include responses to consultations on directive revisions, early access dossiers, pharmacoeconomic studies and pharmacovigilance reports. A terminological error in these documents can jeopardise the outcome of a regulatory procedure.
What are the turnaround times for urgent regulatory translation in Brussels?
For urgent submissions to the Commission or European agencies, TranslateBE offers an express 24-hour option for documents up to 3,000 words and 48 hours for larger volumes. Our Brussels teams are available Monday to Friday and can handle emergencies outside business hours on specific request. Contact us as soon as your deadline is known to guarantee specialist availability.