On February 26, the Center of Drug Evaluation of the NMPA issued the "Notice on Setting up a Legal Document Submission Module on the Patent Information Registration Platform for Marketed Drugs in China" (hereinafter referred to as the "Notice").

The following is the original content of the Notice:

Since the implementation of the "Implementation Measures for the Early Resolution Mechanism for Drug Patent Disputes (Trial)", patent disputes have been resolved simultaneously during the review of generic drug marketing applications. In order to further improve work efficiency and facilitate patent holders, interested parties and generic drug applicants to submit relevant legal documents, a legal document submission module has been set up on the Chinese marketed drug patent information registration platform.

From the date of issuance of this notice, patentees, interested parties or generic drug applicants can directly submit an "application for setting a waiting period", acceptance notice, judgment, decision or settlement on the China Marketed Drug Patent Information Registration Platform etc. There is no need to submit through official documents. For varieties for which relevant information has been submitted, patentees, interested parties and generic drug applicants can directly check the progress and processing results in the "Applicant Window".

If the patentee, interested parties or generic drug applicants have previously submitted information in the form of official documents, and the review of the relevant generic drugs has not yet been completed, in order to facilitate the review of subsequent processing progress and results, the patentee, interested parties or generic drug applicants are requested to Pharmaceutical applicants submit again in the China Marketed Drug Patent Information Registration Platform.

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