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NMPA Announcement on the Issues Related to the Implementation of the Measures for the Implementation of the Mechanism for Early Settlement of Drug Patent Disputes (interim)

CCFDIE|Updated: 2021-07-04

In order to complete the implementation of the Measures for the Implementation of the Mechanism for Early Settlement of Drug Patent Disputes (interim) (hereinafter referred to as the Measures), relevant issues are hereby announced on July 4 as follows:

I. As of today, the China's Patent Information Registration Platform for Marketed Drugs is officially put into operation. Marketing authorization holders of relevant drugs are required to complete the registration and voluntary disclosure of relevant drug patent information on the China's Patent Information Registration Platform for Marketed Drugs in advance as required. Any change to relevant information registered and disclosed in the previous period shall be updated by marketing authorization holders in time. Relevant patent information that has been registered and disclosed shall be used as the basis for the patent declaration made by the applicants for marketing registration of chemical generics, traditional Chinese medicine of the same name and formula and biosimilars. Registration platform and operation instructions can be found in the China's Patent Information Registration Platform for Marketed Drugs at the website of the Center for Drug Evaluation of the National Medical Products Administration (https://zldj.cde.org.cn/home).

II. As of today, in case of filing the application for marketing registration of chemical generics, traditional Chinese medicine of the same name and formula and biosimilars, applicants shall submit the patent declaration in accordance with the requirements of the Measures by contrasting relevant drug patent information registered at the China's Patent Information Registration Platform for Marketed Drugs, and notify the marketing authorization holders of the declaration and basis for the declaration. Where the patent declaration has not been submitted, the application shall not be accepted until the patent declaration is supplemented. The requirements related to the filling, printing and uploading of patent declaration are detailed in the Enterprises Operation Instructions in the Pharmaceutical Business Application System at the Online Service Hall of the NMPA (https://zwfw.nmpa.gov. cn/).