2017 Volume 7 Issue 1 Pages 45-51
Good Registration Management (GRM) is the concept to promote Good Review Practice (GRevP) by review authorities and Good Submission Practice (GSubP) by applicants cooperatively. The purpose of GRM is to enhance quality and efficiency of medical product registration process from application submission throughout review and approval. The GRM was taken up as one of the official topics for regulatory convergence by APEC RHSC in 2015, and its training program has been developed under the APEC Training Center of Excellence (CoE) model by collaborations among the stakeholders from regulatory authorities, industry and academia. Summary of GSubP activities, as an essential element of GRM, will be described together with overall plan of the GRM training program.
