China’s National Medical Products Administration (NMPA) has released a notification indicating the initiation of electronic drug filings, replacing paper filings, starting from January 2023. This move aims to streamline the drug registration process and enhance efficiency.
Implementation Details
Applicants are required to prepare electronic application materials in accordance with relevant regulations and submit them on a CD to the Drug Evaluation Center (CDE). The CDE will conduct acceptance, review, and approval based on the electronic filings. The electronic document of the administrative license for drug registration application acceptance will be pushed in real-time by the “drug business application system” and “drug eCTD registration system.” These electronic documents have the same legal effect as their paper counterparts.-Fineline Info & Tech
