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NMPA Announcement on Issues Pertaining to Online Application for Drug Registration Affairs

CCFDIE| Updated: 2020-12-28

As per the requirements of the Notice of the General Office of the State Council on the Issuance of Implementation Program for Furtherance of the 'Internet + Government Affairs Service' and the 'One Network, One Door, One Time (One Network Online Service, One Door Offline Service and One Time On-Site Service)' Reform and the Guiding Opinions of the General Office of the State Council on Accelerating 'Crossprovincial Handling' of Government Affairs Services, the NMPA has enabled and officially launched on January 1, 2021 the online application module for drug registration affairs.

Applicants for drug registration shall complete user registration and authorization based binding of the drug business application system through the Online Service Hall of the NMPA (https://zwfw. nmpa.gov.cn/) as per the Operation Guidelines for Enterprises on Pharmaceutical Related Application System. As of January 1, 2021, drug registration can be applied online. For the smooth and steady transition of drug registration, relevant drug registration applicants can continue to use the original drug registration application software to fill in the application after the Online Application Module is launched. As of April 1, 2021, application offers generated by the original drug registration application software shall no longer be handled.