The National Medical Products Administration ("NMPA") has recently drawn up and released the Administrative Provisions on On-the-spot Inspections for Drug Registration (Draft for Comment) (the "Draft for Comment") to seek public opinions by June 3, 2019.
The Draft for Comment expressly states that a drug registration applicant shall submit truthful information after its application has been accepted, in accordance with requirements of the national drug evaluation agency, to expound on the trials it has finished, major equipment and instruments involved in these trials, and other particulars, and shall also submit main files concerning trial venues and other materials necessary for inspections. The Draft for Comment notes that the national drug inspection agency will notify an applicant of the upcoming on-the-spot inspection and prepare the inspection plan, depending on the time of applications, their priority and the evaluation progress, adding that the national drug inspection agency will set up an inspection team made up of two or more randomly-selected individuals qualified for the inspections, and the head of the inspection team will bear responsibility. Moreover, the Draft for Comment requires that what needs to be rectified shall be clearly indicated on the list of deficiencies uncovered in on-the-spot inspections, and the entities under inspection shall give written feedback on rectification to the national drug inspection agency within seven days after the end of the inspections.