Pharmacovigilance Requirements Brief Overview

Tajikistan

Pharmacovigilance in Tajikistan is overseen by the Ministry of Health and Social Protection of the Population and the State Service for Supervision of Pharmaceutical Activities. The current Law No. 1893 on Medicines, Medical Products and Pharmaceutical Activities, as amended in 2025, recognises Good Pharmacovigilance Practice among the applicable good pharmaceutical practices. Article 20 establishes pharmacological surveillance under which competent authorities collect, systematise and analyse information concerning adverse effects, medicine interactions and other safety issues. Marketing authorisation Holders, manufacturers and local representatives should maintain suitable processes for collecting and evaluating safety information, forwarding suspected adverse reactions and responding to safety-related requests. The authorities may reassess benefit–risk and take regulatory measures, including changes to product information or withdrawal. Accessible official Tajik material does not clearly publish a universal numerical ICSR deadline, a mandatory locally resident QPPV, a national PSMF format, fixed PSUR/PBRER frequencies or a standard inspection cycle for every MAH. Tajikistan is not an EAEU Member State, so EAEU requirements should not automatically be presented as Tajik law. Product-specific obligations should be confirmed with the State Service. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): Effective Signal Management in Pharmacovigilance.

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