ICAMA
and the US Environmental Protection Agency (EPA) jointly initiated the
evaluation for mutual-Acceptance of GLP. The inception is marked by the visit
of Ms. Francisca E. Liem, head in charge of Good Laboratory Practice program of
EPA (EPA/GLP) during Oct. 13-24, 2014.
The
visit aimed at implementing the Letter Of Intent on Continued Good Laboratory
Practice Standards Compliance Monitoring Project signed by ICAMA and the Office
of Enforcement and Compliance Assurance of EPA(EPA / OECA) in 2013 and
promoting mutual acceptance of data system. The evaluation activities included
a meeting with ICAMA officials and experts, documentation review, on-site
inspection and training course for GLP inspectors.
ICAMA
held a meeting with Ms. Francisca Liem during Oct. 13-14, 2014. Mr. Chen
Youquan, Deputy Director General of the Department of Crop Production of MOA,
and Mr. Sui Pengfei, ICAMA Director General, attended and addressed the
meeting. The meeting was chaired by Ms. Ji Ying, ICAMA Chief Agronomist. In his
speech, Sui welcomed Francisca Liem for her visit to ICAMA. He noted that the
Chinese side highly values the evaluation which marks a milestone for mutual
acceptance of data and hoped for satisfactory outcome. Chen pointed out in his
speech that China-US cooperation mode for GLP can provide reference for
cooperation betweenChinaand other countries, and hoped that US could
offerChinaany help in joining the OECD Working Group on GLP for engaging in
mutual acceptance of data activities. Francisca Liem reviewed relevant
documents which make up the framework ofChina's GLP system to ensure compliance
with EPA/GLP principles. These documents include laws and regulations, records
of inspection, procedures and archives. At the documentation review, Mr. Chen
Tiechun, Director for ICAMA Pesticide Quality Control Division, briefed
Francisca Liem on the development of GLP system inChina. Responsible officials
explained and clarified some questions raised by the guest. GLP system for
in-house tests (lab. tests) required by registration won recognition from
theUSexpert.
To
get detail and better understanding of inspection procedure and requirements of
GLP system inChina, Francisca Liem conducted an on-site visit to a pesticide
enterprise during Oct. 15-17, 2014. She observed the operation of the GLP
system carried out by inspectors at Suzhou Xishan Zhongke Drug R & D Co.,
Ltd., and spoke highly of inspectors' conforming to GLP principles during
operation and the proficiency of audits.
A
training course for GLP inspectors and testing technicians was held in Wuxi,
Jiangsu Province during Oct. 20-22, 2014. The training aimed at enhancing
inspectors' capacity building and accelerating GLP development in experiment
facilities. Francisca Liem, Dr. Ulrich. Schepers from BASF (Germany) and Dr.
Michael Floyd Regehr from BASF (U.S.A), lectured at the training. More than 200
representatives from test facilities and pesticide enterprises attended the
training course. Mr. Sui Pengfei, ICAMA Director General, addressed the
meeting. Sui stressed the significance and urgency of GLP development
inChinaand proposed to establish a GLP working group to further GLP development
in the next step. He called on the inspectors to play greater role in promoting
and leadingChina's GLP development apart from being inspectors. While
highlighting concepts, challenges and responsibilities regarding GLP system,
Mr. Sui put forward requirements for test facilities, stressing that GLP stands
for not only Good Laboratory Practice, but also Global License Pass. The new
conception confirms the vital role GLP plays in the harmonization of pesticide
system. In her closing statement, Ms. Ji Ying, ICAMA Chief Agronomist,
emphasized that reliable data are the basis for the evaluation. She also encouraged
test facilities to develop GLP system and to apply for GLP
certification.
ICAMA
and EPA held a summing-up meeting for the evaluation on GLP system inChinain
Beijing on Oct. 23, 2014. At the meeting, Mr. Gu Baogen, ICAMA Deputy Director
General, thanked Francisca Liem for her support toChina's GLP development. Ms.
Liem had candid communication with ICAMA on deficiencies revealed by the
evaluation, and drew the conclusion that ICAMA's GLP project is in good
compliance with EPA/GLP program. A Memorandum of Understanding on MAD
cooperation is anticipated to be signed by ICAMA and EPA after evaluation on
EPA/GLP system to be conducted by the Chinese delegation.
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false
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X-NONE