Starting on November 1, 2022, China’s NMPA will issue electronic drug certificates for marketing authorization, clinical trials, drug renewals, chemical APIs, etc. The electronic certificate will be as valid as a paper certificate. To be eligible for electronic certificates, drug applicants must register with the Online Service Hall on the NMPA website. Once registered, the applicant will receive an online account number.
Other documents such as the quality standard document, label, package insert, etc. will not be a part of the drug registration electronic certificate, but these other attachments will be available also on the Online Service Hall on the NMPA website. For drug applicants and market authorization holders, electronic files will be more efficient and allow other regulatory groups to access these important certificates more easily.
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.