China’s Center for Drug Evaluation Opens Patent Linkage Registration Platform for Public Testing
On May 18, 2021, the Center for Drug Evaluation of China’s National Medical Products Administration has issued the “Notice on the public testing of the patent information registration platform related to the early settlement mechanism of drug patent disputes and other related matters” (关于药品专利纠纷早期解决机制相关专利信息登记平台公开测试等有关事宜的通知) opening up China’s patent linkage registration platform (similar to the FDA’s orange book) for testing through May 31, 2021. The registration system is available at: https://zldj.cde.org.cn.
A translation of the Notice follows:
In order to implement the “Opinions on Deepening the Reform of the Review and Approval System to Encourage Innovation in Drugs and Medical Devices” and the relevant provisions of the Patent Law, the NMPA has actively promoted the formulation and promulgation of implementation measures for the early resolution of drug patent disputes in conjunction with relevant departments. In order to cooperate with the implementation of the measures, in accordance with the overall work deployment of the State Food and Drug Administration, after internal discussions and consultation with experts and relevant departments, our center has established a patent information registration platform for listed drugs in China, with an explanation of the form and a template for the disclosure of patent statements. The registration platform is now being tested publicly and opinions from all parties are solicited. Test address: https://zldj.cde.org.cn .
Please actively participate in the registration test of relevant drug patent information for the marketing authorization holders of drugs that have been marketed in China. In order to facilitate work connection, after the implementation of the early resolution mechanism for drug patent disputes, relevant patent information that has been registered as required during the test period will be disclosed after confirmation by the drug marketing license holder, as chemical generic drugs, traditional Chinese medicines with the same name, and biosimilars Information on the basis of the patent statement made by the drug applicant. The drug marketing authorization holder is requested to ensure the authenticity, accuracy and completeness of the registered information. The test time is until May 31. At the same time, all sectors of society are welcome to put forward valuable opinions and suggestions so that we can continue to improve. Please send your feedback to email@example.com, copy to firstname.lastname@example.org, and indicate the subject “China Listed Drug Patent Information Registration Platform”
Thank you for your participation and great support.
Drug Evaluation Center of the NMPA
May 18 2021
Instructions and templates are available here (Chinese only):
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