North Korea

Medicines regulation in the Democratic People's Republic of Korea is overseen through the Ministry of Public Health (MOPH) and its National Drug Regulatory Authority (NDRA), as identified in the WHO Pharmaceutical Country Profile for DPR Korea (2025). The profile records no website data for the NDRA, so an official Korean-language regulator link cannot responsibly be supplied. It confirms a 2022 Law and Regulation on Medicine Management, but the current implementing pharmacovigilance provisions are not publicly available from an official national source. A historical WHO assessment reported no functional systematic national pharmacovigilance system at that time, but it must not be treated as evidence of today's position. Current public material does not permit verification of a local QPPV, PSMF, numerical MAH ICSR deadlines, PSUR/PBRER frequencies, RMP obligations, formal signal procedures or a GVP-inspection programme. These requirements must be confirmed with MOPH/NDRA for the applicable authorisation. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): Effective Signal Management in Pharmacovigilance.