China Profile Updated in ClinRegs
April 17, 2020
The China profile in ClinRegs now includes the following updates:
- Updated information on implementing the revised Drug Administration Law (See the Regulatory Authority topic)
- Updated guidance on communication and technical review meetings with the National Medical Products Administration (NMPA) (See Scope of Assessment And Submission Process)
- New material to facilitate the clinical trial application process, such as a submission infographic (See Scope of Assessment and Submission Process)
- Information on a new national ethics committee for gene editing technology (See Authorizing Body)
- New regulations on the administration of clinical trial institutions (See Ethics Committee and Site Investigator/Selection)
- Information on importing specimens (See Specimen Import & Export)
- Incorporation of the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) (See the Clinical Trial Lifecycle, Sponsorship, and Investigational Products topics)
In addition, on March 30, 2020, the NMPA released an updated version of the Measures for the Administration of Drug Registration, which takes effect on July 1, 2020. The ClinRegs team will review the new regulation and incorporate it into the China profile prior to implementation.