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ICAMA, EPA initiate evaluation for mutual-Acceptance of GLP

Release time:2014-10-24page views: Author: Origin:

ICAMA and the US Environmental Protection Agency (EPA) jointly initiated the evaluation for mutual-Acceptanceof 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 Intenton Continued Good Laboratory Practice Standards Compliance Monitoring Project signed by ICAMA and the Office of Enforcement and Compliance Assuranceof 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 QualityControlDivision, 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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