Quote from VigiServe Admin on November 29, 2020, 5:46 AM

In Armenia, Pharmacovigilance is overseen by the Scientific Center of Drug and Medical Technology Expertise (SCDMTE) under the Ministry of Health. The framework is heavily integrated with the Eurasian Economic Union (EAEU) regulations (Decision No. 87 of 2016), meaning compliance largely mirrors standards in Russia, Kazakhstan, and Belarus.

1. Clinical Safety (Clinical Trials)

Safety monitoring during clinical trials is aligned with ICH GCP and EAEU principles.

• Expedited Reporting: Sponsors must report Suspected Unexpected Serious Adverse Reactions (SUSARs) to the SCDMTE according to strict timelines:

  • Fatal or Life-Threatening: Within 7 calendar days.

  • Other Serious Unexpected: Within 15 calendar days.

• Periodic Reporting: Development Safety Update Reports (DSURs) are mandatory and must be submitted annually in the ICH E2F format.

• Oversight: Sponsors are responsible for continuous safety monitoring, causality assessment, and communication with both the regulatory authority and Ethics Committees.

2. Post-Marketing Pharmacovigilance

Post-approval requirements are structured around EAEU compliance, requiring both regional and local oversight.

• Personnel:

  • EAEU Qualified Person (QPPV): Mandatory. Must be a resident of an EAEU member state (often based in Russia for regional hubs), possessing a medical or pharmaceutical degree.

  • Local Person for Pharmacovigilance (LPPV): Generally required or expected by the SCDMTE to serve as a local contact point for reporting and compliance, especially if the EAEU QPPV is located abroad.

• Documentation: A Pharmacovigilance System Master File (PSMF) is required per EAEU guidelines and must be available for inspection.

• Incident Reporting (ICSRs):

  • Serious (Domestic/Unexpected) & Foreign Serious Unexpected: Report within 15 calendar days.

  • Non-Serious Cases: Report within 90 calendar days.

• Periodic Reporting (PSURs):

  • Frequency: Every 6 months for the first 2 years, annually for the next 2 years, and every 5 years thereafter.

  • Format: ICH E2C(R2).

• Risk Management Plans (RMPs): Mandatory for new active substances, biologics, and high-risk products (aligned with EAEU GVP Module V).

Summary of Requirements

Component	Requirement in Armenia
Regulatory Authority	SCDMTE (Scientific Center of Drug and Medical Technology Expertise)
Regional Framework	Eurasian Economic Union (EAEU) GVP
QPPV Requirements	EAEU QPPV (mandatory) + Local Person (expected)
PSMF	Required (EAEU standard)
SUSAR Reporting	7 days (fatal) / 15 days (other serious)
PSUR Frequency	6 months (first 2 yrs) -> Annual (next 2 yrs) -> 5 years