China’s National Medical Products Administration Launches Public Test for Drug Patent Linkage Registration Platform

On May 18, 2021, the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) issued a notice regarding the public testing of its newly developed patent information registration platform. This platform relates to the early settlement mechanism of drug patent disputes and other associated matters. The public testing period is scheduled to run through May 31, 2021.

The registration system is accessible at https://zldj.cde.org.cn, allowing stakeholders to engage with the platform during this testing phase.

This initiative is part of China’s broader efforts to implement the “Opinions on Deepening the Reform of the Review and Approval System to Encourage Innovation in Drugs and Medical Devices” alongside relevant provisions of the Patent Law. The NMPA has actively collaborated with other government departments to formulate and promulgate implementation measures aimed at the early resolution of drug patent disputes.

To support these measures, the CDE, following internal discussions and consultations with experts and relevant departments, established the patent information registration platform specifically for listed drugs in China. The platform includes an explanation of the registration format and provides a template for the disclosure of patent statements.

The CDE has invited marketing authorization holders of drugs already marketed in China to actively participate in the registration test by submitting relevant drug patent information. This includes chemical generic drugs, traditional Chinese medicines with the same name, and biosimilars, based on patent statements made by the drug applicants.

The notice emphasizes the responsibility of drug marketing authorization holders to ensure the authenticity, accuracy, and completeness of the information registered on the platform.

Information registered during the test period will be disclosed after confirmation by the marketing authorization holders, facilitating transparency and compliance once the early resolution mechanism for drug patent disputes is fully implemented.

The CDE encourages all sectors of society to provide valuable feedback and suggestions to improve the platform. Comments can be sent via email to zhangxx@cde.org.cn, with a copy to yjjdc@nmpa.gov.cn, indicating the subject line “China Listed Drug Patent Information Registration Platform.”