Pathology Peer Review

Dec. 27, 2021: FDA Pathology Peer Review in Nonclinical Toxicology Studies: final Q&A Guidance for Industry
September 11, 2019: FDA Pathology Peer Review in Nonclinical Toxicology Studies: draft Q&A Guidance for Industry
July 24, 2015: The Toxicologic Pathology journal published an article entitled "Review of the Organisation for Economic Co-operation and Development (OECD) Guidance on the GLP Requirements for Peer Review of Histopathology". (Free full text)
July 23, 2015: JSTP visited the Department of Quality Assurance at Pharmaceuticals and Medical Devices Agency (PMDA). JSTP presented summary of "Review of the Organisation for Economic Co-operation and Development (OECD) Guidance on the GLP Requirements for Peer Review of Histopathology", which was developed in collaboration with 12 international societies of toxicologic pathology (Toxicologic Pathology, Published online before print July 24, 2015, doi: 10.1177/0192623315596382). The purpose of this review is to provide a unified interpretation of the guidance and serve as a framework for organizations to modify their processes as needed to comply with the guidance. JSTP suggested to PMDA that the framework of Japanese pathology peer review should be unified with other countries. JSTP also requested that PMDA instruct Japanese organizations how to interpret this guidance. PMDA will present the summary of guidance for pathology peer review at the GLP training seminar in this fall. (PDF in Japanese)
July 7, 2015: Symposium titled "Recent topic of pathology peer review in toxicology study" was presented at 42th Japanese toxicology meeting in Kanazawa, Japan.

Chair: Dr. Hiroshi Onodera
S13-1: Dr. Yuji Oishi, "Summary of pathology peer review and progress of GLP requirements" (PDF in Japanese)
S13-2: Dr. Munehiro Teranishi, "Commentary on OECD guidance document for pathology peer review" (PDF in Japanese)
S13-3: Dr. Katsuhiko Yoshizawa, "Differences of perspective between pathology peer review in Europe, US and Japan" (PDF in Japanese)
Discussion
Mar. 17, 2015: Japanese translation of the "OECD No.16 Guidance on the GLP Requirements for Peer Review of Histopathology"
Sept. 26, 2014: The OECD working group on Good Laboratory Practice have published the advisory document "No.16 Guidance on the GLP Requirements for Peer Review of Histopathology". This guidance is as a complement to the guidance provided in page 104-6 of the No. 116 OECD guidance document published in 2012.
Feb. 13, 2014: JSTP issued an updated draft OECD guidance document for pathology peer review (ver2) (Members only)
Please refer to the current version of the guidance: "3.6.3.7 Peer review of histopathology " (page 104-105) in the document No. 116 (PDF).
Jan. 31, 2014: Dr. Onodera, chair of the communication committee, presented "Summary of OECD guidance document for pathology peer review" (Members only) at the luncheon seminar in the 30th annual meeting of the JSTP in Tokushima, Japan.

Dr. Oishi, the member of the International committee, presented "JSTP's progress report - OECD guidance document for pathology peer review" at the luncheon seminar in the 30th annual meeting of the JSTP in Tokushima, Japan (PDF).
Nov. 18, 2013: JSTP presented "the comments of OECD Guidance on the GLP Requirements for Peer Review of Histopathology" to Japanese OECD GLP Working Group, PMDA, JPMA, JACL, JFMDA and JSQA.
Nov. 15, 2013: Executive Committees of the Japanese (JSTP), European (ESTP), North American (STP), British (BSTP), French (SFPT), Indian (STP-I) and the International Federation of Societies of Toxicologic Pathologists (IFSTP) submitted "the comments of Draft OECD Guidance on the GLP Requirements for Peer Review of Histopathology" to OECD (PDF).
Nov. 8, 2013: JSTP visited to PMDA and discussed the draft of OECD guidance document for pathology peer review with JPMA, JACL, JFMDA and JSQA.
Oct. 11, 2013: JSTP discussed the draft of OECD guidance document for pathology peer review with JPMA, JACL, JFMDA and JSQA before the meeting with PMDA.
Sep. 13, 2013: PMDA described the draft of OECD guidance document for pathology peer review at the GLP training seminar (PDFs- Japanese).
Sep. 13, 2013: JSTP contributed the comments on the draft of OECD guidance on the GLP requirements for peer review of histopathology with other major ToxPath societies before sending it to OECD (ESTP meeting at Ghent, Belgium, 2013).
July 25, 2013: PMDA introduced their draft of the OECD guidance document for pathology peer review to JSTP, JPMA, JACL, JFMDA, JSQA and Japan Crop Protection Association (JCPA) (PDF -Japanese).
May 22, 2013: JSTP appealed to PMDA again to provide the current status of the draft OECD document: "Guidance on the GLP requirements for peer review of histopathology" since PMDA did not release the official OECD guidance document by this time (PDF -Japanese).
Jan. 29, 2013: PMDA answered JSTP's questions to the president of JSTP by phone.
1)The status of the draft of OECD guidance document: After releasing the draft OECD guidance document in 2010, OECD advisory members discussed comments from a number of countries.
2)Announcement of guidance document: PMDA is planning to announce the official OECD guidance document in April.
3)The details of the guidance document: PMDA will try to revise the section of peer review of histopathology with flexibility.
Dec. 18, 2012: JSTP requested to PMDA to provide the status of the draft OECD guidance document: "Guidance on the GLP Requirements for Peer Review of Histopathology" (PDF-Japanese).
Sep. 14, 2012: In GLP training seminar, PMDA announced; 1) Study Director (SD) could use the pathology report prepared by Study Pathologist if it is necessary for the final report; 2) the revised draft OECD guidance of peer review of histopathology document was discussed in 2012 OECD GLP Working Group (WG). The major modification in the revision was "the definition of peer review under the GLP" rather than "how to conduct peer review". Members approved the outline and will discuss further details of the guidance.
Sep. 11, 2012: JSTP presented "Peer Review in Toxicologic Pathology - Current Situation in Japan" at ESTP meeting in Stresa, Italy (Abstract-PDF, Presentation-PDF).
Aug. 21, 2012: JSTP will give an oral presentation "Peer Review in Toxicologic Pathology - Current Situation in Japan" and will discuss "INHAND project" at ESTP meeting next month.

PMDA will announce that it will be acceptable that the pathology report is attached in the final report at GLP training seminar in Sep., 2012.
Jan. 16, 2012: The session titled "International Perspective of Pathology Peer Review" was presented at the 3rd Global Quality Assurance Conference (3rdGQAC) in Kyoto, Japan on Nov. 16th (PDF - Japanese).
Aug. 11, 2011: The 3rd Global Quality Assurance Conference (3rdGQAC) will be held at Kyoto, Japan in Nov. 2011. The session for peer review of histopathology will be presented in the morning on Wednesday, Nov. 16, 2011.
Nov. 24, 2010: PMDA submitted the comments of the draft OECD guidance document to OECD after discussing with JSTP, JPMA, JACL, JFMDA and JSQA on Oct. 4th, 2010, (PDF - Japanese).
Aug. 16, 2010: JSTP discussed the draft OECD guidance document "Guidance on the GLP requirements for peer review of histopathology" with PMDA, Japan Pharmaceutical Manufacturers Association (JPMA), Japan Association of Contract Laboratories (JACL), The Japan Federation of Medical Devices Associations (JFMDA) and Japan Society of Quality Assurance (JSQA) (PDF - Japanese).
April 28, 2010: JSTP discussed peer review of histopathology under GLP condition with Pharmaceuticals and Medical Devices Agency (PMDA) (PDF - Japanese).