China Profile Updated in ClinRegs

The China profile in ClinRegs now includes the National Medical Products Administration’s (NMPA) revised Measures for the Administration of Drug Registration, which took effect July 1, 2020.

Please note that NMPA has also released the following requirements which took effect July 1, 2020. The ClinRegs team will review and incorporate these into the China profile this year:

• Guidelines for the Preservation of Essential Documents for Drug Clinical Trials (Published on June 8, 2020) (Google translation of document preservation guidelines)
• Clinical Drug Trial Quality Management Standards (Published on April 26, 2020) (Google translation of quality management standards)
• Measures for the Supervision and Administration of Pharmaceutical Production (Published on March 30, 2020) (Google translation of pharmaceutical production measures)