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.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.
Source used in the article: https://globalforum.diaglobal.org/issue/february-2023/china-applications-for-clinical-trials-and-drug-registration-must-now-be-electronic/