Online Test of China Listed Drug Patent Information Registration Platform

Online Test of China Listed Drug Patent Information Registration Platform

In order to protect the legitimate rights and interests of drug patentees, encourage new drug research and promote the development of high-level generic drugs, establish an early resolution mechanism for drug patent disputes. As a comprehensive system, the early resolution mechanism for drug patent disputes requires the close cooperation of multiple departments and different systems. Organic coordination. Its establishment is not only the concrete embodiment of China's implementation of the first phase of the Sino-US economic and trade agreement, but also the development of China's pharmaceutical innovation and the entry of patent law.The important practice of the "new era. In order to implement the "Opinions on Deepening the Reform of the Review and Approval System and Encouraging the Innovation of Drugs and Medical Devices" and the relevant provisions of the "Patent Law", the State Food and Drug Administration and relevant departments actively promote the formulation and promulgation of the implementation measures for the early resolution mechanism of drug patent disputes.

In order to cooperate with the implementation of the measures, according to the overall work deployment of the State Food and Drug Administration, after internal discussion and consultation with experts and relevant departments, the Drug Evaluation Center of the State Drug Administration has set up a patent information registration platform for listed drugs in China. and set up a form filling instructions, patent declaration disclosure template. In order to better serve the society in the future operation of this platform, we are now conducting a public test of the registration platform and soliciting opinions from all parties. Test Address:https://zldj.cde.org.cnThis test address can be used to learn more about.

The marketing authorization holder of a drug already on the market in China may actively participate in the registration and testing of the relevant drug patent information. In order to facilitate the convergence of work, after the implementation of the early resolution mechanism for drug patent disputes, the relevant patent information registered as required during the testing period shall be made public after being confirmed by the drug marketing license holder, and shall be used as the basis information for the patent declaration made by the applicants for chemical generic drugs, the same prescription drugs of the same name of traditional Chinese medicine and biological similar drugs. In the operation of registration information, the drug marketing license holder shall ensure the authenticity, accuracy and completeness of the registered information.

Test time31 May,At the same time, all sectors of societyPeople can also actively cooperatePut forward valuable opinions and suggestions in orderThe Drug Evaluation Center of the State Drug Administration conducted the registration platform.ContinuedgroundPerfect. Your feedbackCanSendzhangxx@cde.org.cn, cc yjjdc@nmpa.gov.cn, with subject"China Listed Drug Patent Information Registration Platform".

The official online test of the "China Listed Drug Patent Information Registration Platform" marks a substantial step in the implementation of my country's drug patent linking system. People from all walks of life or marketing license holders of drugs already on the market in China are welcome to actively respond to this initiative. The Drug Evaluation Center of the State Drug Administration sincerelyThank you for your participation and support.