Moving to modernize and standardize regulatory review of documentation from pharmaceutical manufacturers, Chinese regulators are launching a pathway to submit pharmaceutical applications, supplements, and reports to authorities using the electronic Common Technical Document (eCTD).
The Center for Drug Evaluation of the National Medical Products Administration (NMPA) plans to begin accepting eCTD submissions for certain kinds of drugs in late December. The drugs include Type 1 preventative and therapeutic biologics, as well as Type 1 and Type 5.1 chemical drugs. Applicants can still submit applications using other electronic and hard copy formats. But using the eCTD format makes the submission process simpler for both applicants and regulators.
The eCTD format was first introduced in 2002 by the International Council for Harmonisation of Technical Requirements for Human Use (ICH), an international consortium of regulatory authorities and pharmaceutical industry leaders. It has been the standard format in use in the United States and in Western Europe for many years.
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/