An incorrect dosage translation may either postpone the approval of the drug or cause a risk to the patient. This is why, for companies engaged in the international pharmaceutical business, translations cannot be treated like a simple tick in the checklist, and it is a major part of compliance. Each country’s regulatory authorities require product information in local languages, which has to be done correctly. This is where pharmaceutical translation services come in. Semantics, which provides translation services in native languages and has an international reach, offers reliable assistance to manufacturers.
What is Pharmaceutical Translation Service?
The scope of these services includes all the documents needed for every stage of the drug life cycle, including:
- Clinical trial protocols
- Informed consent forms
- Patient information leaflets
- Product labels
- SmPCs
- regulatory files
- Safety reports
This work must be carried out by professional linguists who are knowledgeable about both the medical vocabulary as well as the regulatory language that governs the process to ensure utmost accuracy.
What Manufacturers Should Know About Pharmaceutical Translation and Regulatory Compliance
Each Market Has Its Own Rules
Regulatory bodies such as EMA, FDA, PMDA (Japan), and CDSCO (India) have their regulations related to language and format. The European Union is an example where the product information has to be provided in the official languages of the respective member states where the product is sold. Knowing these rules beforehand will save a lot of time and effort in the later stage.
Term Consistency
Inconsistencies could draw the attention of the reviewers. Therefore, it is important to have vocabulary provision for drug names, dosage terms, and adverse event descriptions in the glossary or translation memory.
Patient-Specific Language
Leaflets and labels are meant for patients, not doctors, so they should be written clearly enough for them to understand.
Significance of Data Protection
It is important to understand that clinical data and any unreleased medications are confidential. It is the duty of your translation firm to ensure that the protocols regarding access to data are in place. Look for proof of ISO certification to find out if these controls have been implemented.
Need for Quality Control
It is not advisable to rely on a single translator when working with sensitive information. It is best to get acquainted with the system in use, which should cover independent verification of documents, back translations done when necessary, and approval by the team of specialists before submitting any documents to the regulatory body.
Conclusion
An accurate translation makes a difference between getting approval for a pharmaceutical product or its rejection. The good news is that you don’t have to navigate pharmaceutical translation alone. Semantics provides pharmaceutical translation services to companies, and its work is certified according to ISO 9001 and ISO 27001, which guarantees quality assurance and strong data protection. Having over 5000 native speakers involved in over 150 languages, who have already completed 2500+ projects during 15 years, we know what our clients want. Get in touch with us today and discuss your pharmaceutical translation needs today!
FAQs
What documents require translation in the pharmaceutical industry?
Documents that require translation in the pharmaceutical industry include clinical trial protocols, consent letters, labels, patient brochures, summary of product characteristics, registration documents, and reports of drug safety control.
Can we leverage machine translations to prepare regulatory documents?
The machine outputs can sometimes lack context, confuse the meaning of acronyms, and wrongly claim the dosage instructions. Regulators demand precision, so machine-produced outputs need a lot of editing and improvement by qualified specialists.
What does back translation mean?
It means translating translated texts back to the source language through different translators and enabling the comparison of both versions to understand whether anything has changed in the meaning or content.
What is the usual time required for pharmaceutical document translation?
It relies on the amount of work, languages involved, and revisions needed. For instance, translating small labels may take a few days, while working on a process dossier may last for weeks.
Why is ISO certification vital for selecting a translation vendor?
ISO 9001 means the supplier pursues a systematic quality policy, while ISO 27001 guarantees the protection of confidential data.
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