China drug registration electronic certificates are now possible according to announcement no. 83-2022 by the National Medical Products Administration (NMPA) on October 9, 2022.
As part of the drive to deepen the reform of drug market release and drug supervision, the NMPA will issue electronic certificates for eligible drug registrations in China from November 1, 2022, onwards.
Highlights
- Before the release of this announcement, China drug registration certificates were issued by the NMPA in paper format and then sent to the Marketing Authorization Holder (MAH) by express mail.
- From November 1, 2022, the electronic certificates will be issued for the following applications in China:
- drug clinical trial
- drug marketing license
- drug re-registration
- drug supplementary application
- protection of traditional Chinese medicine varieties
- imported medicinal materials
- chemical raw materials, etc.
- as well as the certificate of drug non-clinical research quality management specifications approved by the NMPA.
- China drug registration electronic certificates have the same legal effect as the paper registration certificate.
- The drug registration electronic certificate not only saves printing, copying, and mailing but it also reduces the timeline to obtaining the certificate by approximately 10 working days at least.
- Electronic drug certificates also means that applicants can receive real-time reminders by SMS to verify the authenticity of the electronic license by scanning the code, and querying the latest status of the electronic license.
- If there is a mistake on the certificate that needs to be corrected, this can be done quicker than for any errors on the paper version.
- The overseas applicant can obtain China drug registration electronic certificates through their local agent’s NMPA account.
- Applicants must incorporate methods of storing drug registration electronic certificates and relevant electronic documents into their quality management system.
Further information
Click here to read the announcement in full.
Or if you would like to know more about our services for China drug registration, please contact us.
