FDA Guidance Breakdown: Translating Non-English GLP Study Reports

A new draft guidance helps sponsors and nonclinical laboratories accurately translate study reports from non-English languages into English.

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The FDA released a new draft guidance on November 21 that outlines the requirements for sponsors and nonclinical laboratories when translating study reports for studies conducted in compliance with good laboratory practice (GLP) regulations (21 CFR part 58) that are submitted for FDA review. The guidance aims to ensure that the language used in the translated reports is accurate and meets the necessary standards.

Below, we briefly distill the key points of the guidance and provide some recommendations for impacted firms in light of it.

Background

In a recent FDA podcast explaining this new guidance, Rick Wasko, a biologist in CDER’s Office of Study Integrity and Surveillance set the stage for this new guidance with some helpful background.

Here’s the gist:

The FDA receives many reports from around the world each year, which are crucial for research and marketing of FDA-regulated products. The FDA GLP regulations are essential for nonclinical laboratory studies. GLP studies involve evaluations like toxicology and safety pharmacology, which are vital for different FDA Centers.

GLP study reports play a significant role in assessing product safety by identifying potential safety concerns and toxic effects. However, the FDA has identified inconsistencies in translation practices across the industry, which require improvement during the agency’s review of these translations.

Some observed issues include:

• Translations of the final study reports may not accurately represent the original raw data.

• Translations with errors such as misspellings, typographical mistakes, omissions, mislabeling, and discrepancies in tables compared to the original reports.

• In some cases, compliance with FDA GLP regulations is claimed in the translated reports but not in the original signed reports. For example, the original report might list the regulations of the country where the study was conducted.

• The practice of signing and dating the translated study reports lacks consistency and can lead to confusion.

To address these issues, the FDA has developed guidance for translating GLP study reports submitted to the FDA. The aim is to standardize the translation process and enhance the quality of these reports.

Key takeaways from the guidance

The definition of a “translated GLP study report”:

• A translated GLP study report is the English version of a report originally written in a non-English language from a GLP study conducted outside the English-speaking regions.

• It's not an amendment but a complete translation of the entire original report, maintaining the same format, tables, appendixes, and amendments.