Q1101. What pharmaceutical standards govern FDA drug approval document translations?

Answered by the NYC Visa & Translation certified translation team

Drug approval documents for the Thai FDA follow the ASEAN Common Technical Dossier (ACTD) format, and the translation practice is shaped by it. The dossier structure: administrative documents and product information (Part I), quality (Part II), nonclinical (Part III), and clinical (Part IV) — with the Thai-language requirements concentrated in Part I: the product label, package insert, and summary of product characteristics must be in Thai for marketed products, and the administrative documents follow Thai FDA forms. The translation workflow: the foreign manufacturer's quality and clinical documentation is generally submitted in English (the FDA accepts English technical sections); the Thai label and insert translation must follow the FDA's labelling requirements exactly — the Thai product name, the active ingredients with strengths, indications, dosage, warnings, and storage conditions in the prescribed order; and the manufacturing-site documents (GMP certificates, CPP — Certificate of Pharmaceutical Product) follow the legalisation chain for the administrative file. Standards that matter: the CPP follows the WHO format and is the anchor document for imported product registration — its data fields must match the dossier exactly; stability data and specifications are transcribed with their methods and limits exact; and for biological products and vaccines, the additional lot-release and cold-chain documentation adds layers. Timing: label and insert translation on a timeline confirmed after document review per product; full administrative file preparation longer. Confirm the Thai FDA's current requirements for the specific product category (modern drug, generic, biological) before preparing the dossier.