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Revised Data Requirements for China Pesticide Registration Issued
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By J. Brian Xu, M.D., Ph.D., DABT®

On September 29, 2017, the Ministry of Agriculture of China (MOA) issued the final revisions to Data Requirements on Pesticide Registration (MOA Proclamation No. 2569).  The revisions will become effective on November 1, 2017, under the new Regulation on Pesticide Administration (RPA) and Pesticide Registration Management Measures (MOA Order No. 3, 2017).  The draft revisions to Data Requirements on Pesticide Registration were initially released for public comment on June 30, 2017.  The new Data Requirements include 10 chapters and 14 annexes and a category of pesticides for specialty minor crops has been added.  More information on China’s new pesticide regulations is available in our blog under key word China.

Commentary

MOA Order No. 3, 2017 requires chemistry and toxicology tests to be completed in laboratories located in China approved by the MOA or overseas laboratories that have a mutual recognition agreement with the relevant Chinese Authority.  The new Data Requirements on Pesticide Registration do not provide any additional information about the acceptance of data generated in overseas laboratories.

It remains unclear whether, for example, for literature or data prepared in a foreign language, entire study reports/articles, or only summaries, must be translated into Chinese.  In addition, the final revision of Data Requirements on Pesticide Registration deletes the category of “Pesticides for Overseas Uses Only” that was set forth in the draft revision of Data Requirements on Pesticide Registration.

The new RPA, MOA Order No. 3, 2017, and the Data Requirements on Pesticide Registration significantly change the registration requirements and the registration process for pesticides in China.  These new requirements, and the many ambiguities they contain, will likely extend the time for obtaining registrations and impose additional challenges on manufacturers to overcome, particularly foreign manufacturers who wish to bring pesticide products to the Chinese market.