Frontier Information | Interpretation of FDA's Translation of Good Laboratory Practice (GLP) Research Report: Questions and Answers Industry Guide (Draft)
2024-01-22
On November 23, 2023, several centers or offices of the U.S. Food and Drug Administration (FDA) jointly issued a guide entitled "Translation of Good Laboratory Practice (GLP) Research Reports: Questions and Answers Industry Guidelines (Draft)" (Translation of Good Laboratory Practice Study Reports: Questions and Answers Guidance for Industry(DRAFT GUIDANCE)) to provide guidance on how to translate GLP-compliant research reports, to ensure the standardization, clarity and accuracy of the translation of GLP research reports to support regulatory decision-making.
The main contents include:
The translation of the GLP research report should reflect the original report truthfully, accurately and completely, and the translators should have relevant academic qualifications and experience;
The translation of the GLP study report shall contain a translation statement, stating the translator's information, the date of translation, and certifying that the translated version faithfully reflects the original report;
A written translation procedure shall be established, including the qualification requirements for translators and the documented management requirements for the translation process;
The final report of the translated GLP study shall be retained together with the original report, and the revised report shall be translated separately;
The second person shall review the integrity of the translation report;
The translated version does not require a signature, but should contain the name of the person involved in the original report and the date of signature.
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