10th European Congress of Toxicologic Pathology
September 11 – 14, 2012
Stresa, Italy

Title of thePresentation:Author(s):name(s) &affiliation(s):Peer Review in Toxicologic Pathology - Current Situation in Japan
Harada T, Nishikawa A, Oishi Y, Suzuki M, Teranishi M, Yoshida M,
Yoshizawa K, and Mitsumori K
Peer Review Ad hoc Working GroupThe Japanese Society of Toxicologic Pathology

It is generally accepted that pathology peer review (PPR) is an important
Abstract Text: procedure to verify and improve the accuracy and quality of histopathology data
generated by the study pathologist in toxicological studies of xenobiotics
including pharmaceuticals and agrochemicals with experimental animals.
However, the timing of PPR relative to data locking and the definition of raw
data differ among countries. In the United States and Europe, PPR is usuallyconducted before pathology data are fixed or locked. In Japan, internal PPR
within the testing facility is conducted before data locking, but sponsor PPR ismostly performed after pathology findings are fixed, which is in line with theguidance described in the GLP Guidebook 2006 that is recommended by theJapanese representative regulatory agency, Pharmaceuticals and Medical
Devices Agency (PMDA). The purpose of the guidance by PMDA appears toensure transparency of PPR process and to minimize the influence of sponsor
power on the original data by the study pathologist. In order to clarify differencesin definition of pathology raw data and peer review process among countries, aPanel Discussion on Regulatory Perspective for Pathology Data was held during
the 25th Annual Meeting of the Japanese Society of Toxicologic Pathology(JSTP) at Hamamatsu in 2009. The panelists who participated in the discussion
represented multiple societies of toxicologic pathology including the JSTP,
Society of Toxicologic Pathology (STP), and European Society of ToxicologicPathology (ESTP) together with the Japanese Society of Quality Assurance(JSQA). It was also cooperated by the International Federation of Societies ofToxicologic Pathology (IFSTP) and its Regulatory Interaction Committee (RIC)
for assistance in pursuing a globally acceptable approach to peer review. At thatmeeting, it was revealed that USA and European regulatory agencies do not
request that data be locked before peer review or an audit trail of changes in thepathology report be produced, which is different from that in Japan. Sinceinternational harmonization of PPR practices is very important, the JSTP andother relevant parties including JSQA had a face to face meeting with PMDA in2010 to discuss the differences between Japan and other countries and also thecontent of a draft OECD guidance on pathology peer review. At the meeting, theJSTP recommended to PMDA that PPR prior to data locking would be moresuitable to improve the quality and reliability of pathology data to be submitted toregulatory agencies. The JSTP position is consistent with that of STP which isshown in “Recommendations for Pathology Peer Review” by the STP Peer
Review Working Group published in Toxicologic Pathology in 2010. PMDA also
gathered information on PPR in other countries as much as possible. Taken
together, PMDA showed new draft viewpoints on PPR at the 3rd Global Quality
Assurance Conference which was held at Kyoto in 2011. The PMDA’s draft
viewpoints are summarized as follows: PPR is not mandatory to nonclinical studies of pharmaceutical products,
but if PPR is carried out, then it is subject to GLP inspection.
 At the moment, PMDA considers that pathology raw data is the report orESTP Speaker Abstract Form 2012

10th European Congress of Toxicologic Pathology
September 11 – 14, 2012
Stresa, Italy
data signed and dated by the study pathologist.
 PPR before or after data locking would be acceptable either way, but
PPR by pathologists outside from sponsors or academia may berequired to ensure the transparency of review process and to be
described in the protocol if the conduct is scheduled in advance.
 In addition, the name of the pathology peer reviewer and reviewed
organs with disagreement should be described in the final report.
 The report or data generated by the peer reviewer should be archived
together with the other study documents.
The JSTP basically agree with the new draft viewpoints of PMDA, although weneed further discussions in details before it is finalized.

ESTP Speaker Abstract Form 2012