Decision questionDo quality, safety, efficacy and the benefit-risk balance support the proposed label, and do trials protect participants and generate reliable, traceable data under current GCP?
Required evidence / materialsCMC, nonclinical evidence, clinical evidence compliant with 2026 GCP, proportionate quality management, safety management and further information
Can iterate or branchFurther information or conditional approval; subsequent indication changes require separate approval; trial quality controls may adapt to risk and critical information
Source dateCN-S09 · Announced 21 May 2026; published 8 Jun 2026; effective 1 Sep 2026;CN-S18 · 2020-01-22;CN-S19 · 2026-05-15;CN-S06 · 2020-07-31 / 2020-09-01;CN-S10 · 2026-04-17;CN-S17 · 2026-05