Translation of Good 
Laboratory Practice Study 
Reports: Questions and 
Answers 
Guidance for Industry 
 
DRAFT GUIDANCE 
 
  This guidance document is being distributed for comment purposes only. 
 
Comments and suggestions regarding this draft document should be submitted within 90 days of 
publication in the Federal Register of the notice announcing the availability of the draft 
guidance. Submit electronic comments to https://www.regulations.gov. Submit written 
comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the 
docket number listed in the notice of availability that publishes in the Federal Register. 
 
For questions regarding this draft document, contact (CDER) Office of Study Integrity and 
Surveillance at CDER-OSIS-GLP@fda.hhs.gov or 240-402-6002, (CBER) Office of 
Communication, Outreach and Development at 800-835-4709 or 240-402-8010, (CDRH) Office 
of Device Evaluation at 301-796-5550, (CVM) Office of New Animal Drug Evaluation at 
AskCVM@fda.hhs.gov, (CFSAN) Office of Center Director at CFSANBIMO@fda.hhs.gov, 
(CTP) Small Business Assistance at 1-877-287-1373, or Office of Regulatory Affairs (ORA) at 
ORAPolicyStaffs@fda.hhs.gov. 
  
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
Center for Biologics Evaluation and Research (CBER)  
Center for Devices and Radiological Health (CDRH)  
Center for Veterinary Medicine (CVM) 
Center for Food Safety and Applied Nutrition (CFSAN)  
Center for Tobacco Products (CTP) 
Office of Regulatory Affairs (ORA) 
 
November 2023 
Pharmacology/Toxicology 
   
Translation of Good 
Laboratory Practice Study 
Reports: Questions and 
Answers 
Guidance for Industry 
 
Additional copies are available from: 
 
Office of Communications, Division of Drug Information  
Center for Drug Evaluation and Research 
Food and Drug Administration 
10001 New Hampshire Ave., Hillandale Bldg., 4th Floor  
Silver Spring, MD 20993-0002  
Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353 
Email: druginfo@fda.hhs.gov  
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs  
 
and/or 
 
Office of Communication, Outreach and Development  
Center for Biologics Evaluation and Research 
 Food and Drug Administration 
10903 New Hampshire Ave., Bldg. 71, Room 3128 
Silver Spring, MD 20993-0002 
Phone: 800-835-4709 or 240-402-8010 
Email: ocod@fda.hhs.gov 
https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances   
   
and/or 
 
Office of Policy 
Center for Devices and Radiological Health 
Food and Drug Administration 
10903 New Hampshire Ave., Bldg. 66, Room 5431 
Silver Spring, MD 20993-0002 
Email: CDRH-Guidance@fda.hhs.gov 
https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-
and-radiation-emitting-products  
 
and/or 
 
Policy and Regulations Staff, HFV-6 
Center for Veterinary Medicine 
   
Food and Drug Administration 
7500 Standish Place, Rockville, MD 20855 
https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry 
 
 and/or 
 
Office of Nutrition and Food Labeling Nutrition Programs Staff, HFS-830 
Center for Food Safety and Applied Nutrition Food and Drug Administration 
5001 Campus Drive College Park, MD 20740 
http://www.fda.gov/FoodGuidances 
 
and/or 
 
Office of Small Business Assistance 
Center for Tobacco Products 
Document Control Center, Bldg. 71, Room G335, 10903 New Hampshire Ave. 
Silver Spring, MD 20993-2000. 
http://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/default.htm 
 
and/or 
 
Division of Operational Policy 
Office of Regulatory Affairs 
Food and Drug Administration 
12420 Parklawn Drive. Room 4044 
Rockville, MD 20857 
ORAPolicyStaffs@fda.hhs.gov. 
 
 
 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
Center for Biologics Evaluation and Research (CBER)  
Center for Devices and Radiological Health (CDRH)  
Center for Veterinary Medicine (CVM) 
Center for Food Safety and Applied Nutrition (CFSAN)  
Center for Tobacco Products (CTP) 
Office of Regulatory Affairs (ORA) 
 
 
 
November 2023 
Pharmacology/Toxicology 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
TABLE OF CONTENTS 
 
 
 
I.  INTRODUCTION............................................................................................................. 1 
II.  BACKGROUND ............................................................................................................... 2 
III.  QUESTIONS AND ANSWERS ....................................................................................... 2 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
Translation of GLP Study Reports: Questions and Answers 
1 
Guidance for Industry1 
2 
3   
4   
5  This draft guidance, when finalized, will represent the current thinking of the Food and Drug 
6  Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not 
7  binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the 
8  applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible 
9  for this guidance as listed on the title page.   
10   
11   
12   
13   
14  I.  INTRODUCTION  
15   
16  This guidance provides information to sponsors and nonclinical laboratories regarding the 
17  language translation of study reports for studies conducted in compliance with good laboratory 
18  practice (GLP) regulations (21 CFR part 58).2,3 GLP studies include, but are not limited to 
19  nonclinical toxicology studies, safety pharmacology studies, and device safety studies received 
20  by different FDA Centers. When study reports of GLP studies are translated from their original 
21  language into English, adequate documentation is critical to ensure accurate and complete study 
22  data are submitted to FDA. This question-and-answer document is intended to clarify FDAs 
23  recommendations concerning the translation of study reports from a non-English language into 
24  English for studies conducted in compliance with GLP regulations. We expect that the 
25  recommendations for translating GLP study reports described in this guidance will increase our 
26  stakeholders understanding of the documentation needed to ensure study reports translated from 
27  the original language into English are clear, accurate, complete, and truthful.  
28   
29  This draft guidance does not address the reliable translation of other study reports submitted to 
30  support a marketing authorization, including studies that are not conducted in compliance with 
31  GLP regulations, but the concepts described in the guidance may be informative for the 
32  translation of study reports from those studies that are intended for submission to FDA to support 
33  a marketing authorization. FDA may issue guidance regarding questions & answers for the 
 
1 This guidance has been prepared by the Office of Study Integrity and Surveillance in the Center for Drug 
Evaluation and Research in cooperation with the Center for Biologics Evaluation and Research, Center for Devices 
and Radiological Health, Center for Veterinary Medicine, Center for Food Safety and Applied Nutrition, Center for 
Tobacco Products, and Office of Regulatory Affairs at the Food and Drug Administration.  
 
2 An accurate and complete translation is a regulatory requirement if any part of the application submitted to FDA is 
in a foreign language (21 CFR 312.23 (c) and 21 CFR 514.1(a)). 
 
3 We support the principles of the 3Rs, to reduce, refine, and replace animal use in testing when feasible. We 
encourage sponsors to consult with us if it they wish to use a non-animal testing method they believe is suitable, 
adequate, validated, and feasible. We will consider if such an alternative method could be assessed for equivalency 
to an animal test method.   
  1  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
34  translation of other study reports submitted to FDA in support of marketing authorizations as 
35  appropriate.  
36   
37  In general, FDAs guidance documents do not establish legally enforceable responsibilities. 
38  Instead, guidances describe the Agencys current thinking on a topic and should be viewed only 
39  as recommendations, unless specific regulatory or statutory requirements are cited. The use of 
40  the word should in Agency guidances means that something is suggested or recommended, but 
41  not required.  
42   
43   
44  II.  BACKGROUND 
45   
46  Studies conducted in compliance with GLP regulations (21 CFR part 58) are sometimes 
47  conducted by testing facilities located outside of the United States. In instances where the GLP 
48  study report is generated in a non-English language, the study report is often translated into 
49  English for submission to FDA. When translating a study report into English from a study 
50  conducted in compliance with GLP regulations, the translation should be clear, accurate, 
51  complete, truthful, and follow written processes and procedures. The sponsor should ensure that 
52  the translated report is an accurate representation of the original GLP study report. 
53   
54   
55  III.  QUESTIONS AND ANSWERS     
56   
57  Q1: What is a translated GLP study report? 
58   
59  A1: For purposes of this guidance, a translated GLP study report is an English language study 
60  report rendered from a GLP study that was conducted in a non-English speaking country/region 
61  where the original study report was generated in the testing facilitys native language. The 
62  translated GLP study report is not an amendment to the study report, but rather the original study 
63  report in its entirety translated from the original language into English. The translated GLP study 
64  report should be the clear, accurate, complete, truthful representation of the original report text 
65  and tables with captions, including but not limited to, the study summary, materials and methods, 
66  results, discussion, and conclusion sections and should use the same format, tables, appendixes, 
67  and amendments as the original report. It is understandable that different words/sentences may 
68  be used to translate a report into English; however, the content should be an accurate and 
69  complete representation of the original study report.  
70   
71  Q2: What qualifications should the translator(s) hold? 
72   
73  A2: English translation should be performed by a translator or translators with education, 
74  training, experience, or combination thereof, in English and in the original language being 
75  translated. The translator(s) should be familiar with translating medical and scientific documents 
76  into English. The requirements and qualifications of the translator(s) should be clearly described 
77  in written processes and procedures (see Q4 below).   
78   
79   
  2  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
80  Q3: Should a translation statement be included in the translated GLP study report? 
81   
82  A3: Yes, the translator(s) should generate a signed and dated translation statement or certificate, 
83  separate from the translated GLP study report, which should be placed immediately in front of 
84  the translated study report cover page. 
85   
86  The translation statement or certificate should include the following: 
87   
88    Name of the person(s) that performed the translation and their affiliation 
89    Translator(s) qualifications 
90    Date(s) the translation was performed 
91    Statement signed by the translator(s) attesting that the translated document is a clear, 
92  truthful, accurate, and complete representation of the original GLP study report. 
93   
94  Q4: Should written procedures be in place for the translation of GLP study reports? 
95   
96  A4: Yes, the sponsor or testing facility, as applicable, should have written procedures in place for 
97  GLP study report translation for studies conducted in compliance with GLP regulations. These 
98  written procedures should include requirements for translator qualifications and requirements for 
99  the translation, such as documentation, verification of translation accuracy, and completeness 
100  checks. Current written procedures should be available to, and followed by, the translator.  
101   
102  Q5: Should the translated final study report be retained by the sponsor or testing facility? 
103   
104  A5: The translated GLP study report should be retained along with the original study report by 
105  the sponsor or testing facility, as applicable. Communications related to the translation should be 
106  documented and retained by the sponsor or testing facility who was responsible for the 
107  translation.  
108   
109  Q6: Should the final study report amendments be translated separately from the original 
110  final study report? 
111   
112  A6: Yes, each amendment to the original final study report should be translated as a separate 
113  document. The final study report and all versions of final study report amendments should be 
114  kept as separate individual documents. 
115   
116  Q7: Should GLP study report tables and appendixes be translated? 
117   
118  A7: Yes, the entire GLP study report, inclusive of all tables, appendixes, contributing scientist 
119  reports, and protocol and any amendments, should be accurately and completely translated into 
120  English. Data tables should include the same tabular data, with the same format and translated 
121  text, including but not limited to table headers, units, tissue names, captions, and footnotes, as in 
122  the original report.  
123   
124   
125   
  3  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
126  Q8: Should the translated GLP study report be reviewed for completeness?  
127   
128  A8: Yes, the complete translated GLP study report should be reviewed by a second person (e.g., 
129  testing facility staff, sponsor staff), apart from the translator, to check the report format, tabular 
130  content, and figures (graphical representation of data) for completeness. This second person does 
131  not need to be fluent in scientific and medical terminology or English. The review for 
132  completeness should be performed on the final version of the translated study report. If issues are 
133  identified during the completeness check, the translated study report should be returned to the 
134  translator for review and revision, as appropriate. If changes are made to the translated report in 
135  response to the review, another completeness check should be performed. The process should be 
136  documented and retained with the study records and report. 
137   
138  Q9: Should the translated GLP study report include signatures?  
139   
140  A9: The translated GLP study report should not be signed. The translated GLP study report 
141  should include, at a minimum, the typed names of the study director, quality assurance auditor, 
142  and testing facility management and the signature dates from the original final study report.  
143   
144  The study report translator should sign and date the translation statement, which is separate from 
145  the translated study report, as outlined in A3 above. 
  4