China Pesticide Registration: Unilateral Acceptance of Overseas GLP Data to Cease

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China Pesticide Registration: Unilateral Acceptance of Overseas GLP Data to CeaseUnilateral acceptance of test reports from overseas GLP laboratory will no longer be supported. A transitional period before the implementation of this new stipulation is being considered.

On 1 Nov 2017 China begins practical implementation of new pesticide regulations. After this date all subsequent pesticide registration applications will be reviewed under new data requirements. New regulation specifies that test reports should be issued by a MoA-recognized testing facilities or overseas labs from a country or organization which have signed MAD (Mutual/ multilateral Acceptance of Data) agreement with China. The report from overseas OECD GLP labs (which China has recognized for decades) will no longer be usable in China. During the 9th Chemical Regulatory Annual Conference, Mr. Chen Tiechun from ICAMA introduced how GLP principles will be adopted for laboratory monitoring and shared with the audience the latest MAD achievements.

 

Experimentation Management under New Pesticide Regulatory System

In the past transparent and clear requirements on laboratory testing have not been available, requirements were based on ICAMA’s on laboratory inspection guidance and MoA’s voluntary measures on GLP-compliance. In fact there was no strong legislative or regulatory basis managing this aspect of pesticide administration in China. Under the new legislation, a ministerial regulation (which will parallel the regulations managing registration, production, marketing and management) was promulgated and two new mandatory supporting rules on laboratory accreditation and GLP management have been issued issued under the MoA Announcement 2570. Under this new framework testing labs are regarded as other business entities such as registrant, producers and dealers:

 

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