Promoting the Quality of Medicines (PQM) Program

A Minilab® Basic Testing of anti-TB medicines at a Sentinel Site in Zamboanga City.
The Philippines is considered a high-burden tuberculosis (TB) country by the World Health Organization’s Global Tuberculosis Report 2012. That situation is compounded by development of multi drug-resistant tuberculosis (MDR-TB) which is generated primarily due to the large numbers of TB patients who are inadequately treated. There is a need to improve the quality assurance system for anti-TB medicines being purchased and used in the national TB control program, and to develop and implement strict regulatory control and put measures in place for the sale and supply of anti-TB medicines in the private sector, which challenges government efforts to control MDR-TB.

Since 2007, the United States Agency for International Development and the United States Pharmacopeia Convention (USP) have been actively providing technical and professional assistance to the Philippines Food and Drug Administration, the Department of Health and the National Tuberculosis Program to strengthen the Quality Assurance and Quality Control System for medicines in the Philippines.

The assistance focuses on establishing post-marketing surveillance through the medicines quality monitoring (MQM) program to ensure the quality of tuberculosis medicines available on the market in Philippines. The monitoring program also aims to enhance the FDA regulatory capacity in evaluation & registration of pharmaceutical products through the introduction and build-up of internationally accepted quality standards, guidance, processes and procedures.

The PQM program’s main activities have been focused on (1) Establishing a mechanism for detection of poor-quality tuberculosis medicines through post-marketing surveillance; (2) Strengthening the capacity of the Philippines FDA by providing essential equipment and training; (3) Disseminating objective and up-to-date information about medicines quality and raising awareness among the general public about medicine quality issues to mobilize policy makers, regulators and health professionals.

The MQM program established at eight sites in the Philippines with a focus to build closer surveillance at the areas with a high TB incidence and increased resistance to TB medicines. PQM and the FDA work in close collaboration with CHDs and LGUs to monitor the quality of TB medicines with the goal to ultimately reduce the poor quality TB medicines circulating in the country.

To strengthen the capacity of the Philippines to improve and sustain quality assurance and quality control of medicines.

Last updated: September 14, 2015

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