Pharmacy
Compliance with pharmaceutical industry regulations
Depending on the market where a medicine is to be introduced, different guidelines apply. In the European Union the regulatory body is EMA (European Medicines Agency), in the United States FDA (Food and Drug Administration) and in Japan MHLW (Ministry of Health, Labour and Welfare). Most often we provide pharmaceutical translations for companies and entities within the European Economic Area (EEA) based on guidelines issued by the European Medicines Agency. EMA is responsible for the scientific evaluation of innovative medicinal products. Its established guidelines are available to all manufacturers and reflect the most up-to-date conclusions on the development of biomedical sciences.
Examples of documents requiring translation
- Patents
- Descriptions of pharmaceutical manufacturing processes
- Summaries of product characteristics (SmPC)
- CTD (Common Technical Document) registration dossiers
- Documentation on validation of analytical methods
- Medicine and dietary supplement leaflets, packaging labels (PILs)
- Scientific publications and articles
- Marketing materials and pharmaceutical labels
Pharmacovigilance
The monitoring of the safety of medicinal products covers their entire life cycle on the market. Safety monitoring activities are subject to legal regulations worldwide. Pharmacovigilance (PhV) involves activities and studies related to the detection, assessment, understanding and prevention of adverse effects or any other problems arising from the use of medicinal products. Monitoring adverse reactions enables a rapid response whenever risks associated with medicine use are identified.
Translations of registration dossiers
The registration of a medicine requires the preparation of scientific and administrative documentation. In recent years scientific documentation has been standardised and regulated by guidelines to make the registration process clear for all responsible parties. To this end the CTD (Common Technical Document) format has been introduced, which applies to all entities responsible for a medicinal product.
Translations of product materials
Patient safety relies on accurate and unambiguous translation of product materials. Information on composition, indications, dosage, contraindications, interactions, warnings, adverse reactions and storage conditions is essential not only for patients but also for medical professionals. Translating pharmaceutical content requires particular care in maintaining accuracy in nomenclature, numerical values and medicine dosages. For translations of product documentation we recommend our service compliant with ISO 17100:2015.