Sep. 28, 2012
Following participation in the 19th OECD GLP Working Group Meeting in 2005 as an ad hoc observer, China has been working actively to promote the progress of GLP for adhering to OECD GLP Mutual Acceptance of Data (MAD). Over recent years, the establishment of GLP system in China has progressed significantly, which are outlined as the following:
1. Establishment of GLP System
Over recent years, China has established and issued series of GLP related regulations and guidance documents including Management Procedure for the Monitoring of Good Laboratory Practice for Pesticides (MOA Notice No.739 ), Requirements for GLP inspector and Evaluation Form and Criteria for GLP Compliance.
There have been clear descriptions of regulations relevant to the whole GLP system, from inspection and management of GLP recognized Labs, selection of GLP inspector, GLP recognization application, data review and on-site inspection, certificate issuance and supervision.
Agricultural industry standards of GLP principles for safety evaluation on pesticide physiochemical, residual, toxic and environment effect have been established, which provides a strong technical support for the establishment and management of GLP recognized labs.
2. Promote to make research on and establish Pesticide Safety Assessment Test Method
There are two preconditions for achieving international MAD: one is to comply with GLP principles, the other is to apply internationally acceptable guidelines like OECD guidelines. Both can’t lack.
According to Regulation on pesticide registration data requirement and GLP principle while referring to the test method of OECD and U.S. EPA, in recent years, China has revised its pesticide test methods and has translated all the latest OECD guidelines, which provides an important technical support for China’s OECD GLP MAD progress.
3. GLP training program
China has translated and published the Chinese version of OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring and its revisions, which has greatly increased GLP knowledge and awareness.
Since 2005, GLP inspectors from US, Germany etc. have been invited to hold on-site training courses for Chinese GLP inspectors and technicians from test facilities; Some Chinese inspectors also have been invited to participate in several GLP inspections conducted by EU inspectors as observer.
4. GLP recognition
According to the results of the GLP inspection in 2010 based on MOA Notice No.739, 6 pesticide GLP laboratories were recognized in May 2010 by Chinese Ministry of Agriculture including the Safety Assessment Center of Shenyang Chemical Research Institute.
5. Push forward the progress of International MAD
In recent years, China has strengthened exchange and communication with OECD GLP working group to have more knowledge on the policies and latest development of OECD GLP MAD and introduce China’s GLP progress.
A LOI on GLP has been signed between U.S. EPA and ICAMA to hold training courses and carry out inspection jointly.
While China becoming an important player in the global pesticide market, pesticide products in China should be regulated according to international standards. To ensure the data quality, China will strengthen labs management and promote the establishment of GLP recognized labs.
The legislation, personnel training and capacity building on China’s GLP system will be enhanced to ensure China achieving full adherent status on OECD GLP MAD finally.
Interview and edit by: Christina Tse, Judy Zhang and Xiayang Zhou.
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