Promoting the Quality of Medicines Plus

OVERVIEW

USAID’s Promoting the Quality of Medicines Plus (PQM+) activity, led by US Pharmacopeia in partnership with the Government of Kazakhstan, Ministry of Health (MOH), National Center of Expertise of Medicines and Medical Devices and Committee for Medical and Pharmaceutical Control under the MOH, advances cross-sectoral and systems strengthening approaches to improve access to quality-assured medicines within the country’s supply chain system.

GOAL

The goal of PQM+ in Kazakhstan is to strengthen national pharmaceutical regulatory systems, including medical product quality assurance systems.

ANTICIPATED RESULTS

Technical assistance from the USAID Regional Mission for Central Asia, through PQM+, will result in:

Regulatory systems strengthened to meet WHO Global Benchmarking Tool standards.
Karaganda and Almaty Medicine Quality Control Laboratories becoming the first WHO-prequalified laboratory in Central Asia.
The National Center of Expertise of Medicines and Medical Devices implementing WHO Collaborative Registration Procedure for the accelerated registration of WHO prequalified medicines to foster faster regulatory approvals and earlier access to essential medicines.
The Kazakhstan Pharmaceutical Inspectorate, and other key bodies of the Government of Kazakhstan, joining the Pharmaceutical Inspection Cooperation Scheme to ensure the quality of medicinal products in line with Good Manufacturing Practice standards.
Introduction of Risk Based-Post Marketing Surveillance, and related systems, to conduct medicine quality surveillance after products are released on the market.
Improved pharmacovigilance systems to detect, investigate, and analyze adverse events following immunization (AEFI). This includes the development of AEFI surveillance guidelines; a three-year pharmacovigilance roadmap; and trainers for pharmacovigilance capacity strengthening.
Improved lot release systems to enable continuous quality and safety monitoring of biological products through a regulatory release system on a lot-by-lot basis.
Improved medical device inspection systems including the training of medical device inspectors and the registration department.