China NMPA Mandates Drug Registrations via E-Submission

Recently, China has shifted towards electronic submissions in an effort to expedite the review and approval process for drugs. At the end of November 2022, the China NMPA announced that starting January 1, 2023, all drug registration applications as well as supplementary information need to be submitted electronically in lieu of paper submissions. Before this announcement, the NMPA required hard copies of most documents and only required a few documents to be submitted via compact disc. However, starting this year, all documents will need to be in PDF format and stored in a compact disc, which will be submitted to the NMPA.