Quote from VigiServe Admin on February 10, 2026, 11:29 AM

In North Korea (DPRK), the pharmacovigilance system is non-functional and opaque by international standards. There is no transparency, no independent regulatory oversight, and no adherence to global safety monitoring norms (ICH/WHO). The system is entirely state-controlled under the Ministry of Public Health.

1. Clinical Safety (Clinical Trials)

Clinical trials are rare, state-run, and do not follow international GCP standards.

• Framework: Internal state directives only.

• Expedited Reporting: No known external reporting requirements. Safety data is handled internally by state entities with no transparency.

• Submission: Internal state channels only.

2. Post-Marketing Pharmacovigilance

There are no enforceable obligations for industry. The concept of an independent Marketing Authorization Holder (MAH) effectively does not exist in the domestic context.

• Personnel & Infrastructure:

  • No Local QPPV: Not required.

  • No PSMF Mandate: Not required.

• Incident Reporting (ICSRs):

  • Enforcement: None.

  • Practice: No public reporting mechanism exists.

• Risk & Periodic Reporting:

  • PSURs/RMPs: Not required.

Summary of Requirements

Component	Requirement in North Korea
Regulatory Authority	MoPH (Ministry of Public Health - State)
Framework	None / State Directives
Local QPPV / PSMF	Not required
Safety Reporting	Internal / None
Clinical Reporting	Internal State Control
Submission Language	Korean