Drug regulatory study tour


FDA shares development experience, best practices w/ Mongolian legislators, regulators

The Food and Drug Administration (FDA) Philippines recently welcomed legislators from the Parliament of Mongolia and the senior staff of the Ministry of Health (MOH) of Mongolia for a drug regulatory study tour aimed to help them for their planned revision of their Mongolian Medicines Law.

Five members of the parliament and four MOH senior officials came for a direct exposure on the country’s FDA establishment, and its organization and management system set-up. They also took notes on the FDA’s development of its regulatory and enforcement system.

FDA Acting Director-General Dr. Kenneth Hartigan-Go spent time with the delegates to share them the agency’s experiences and best practices. He also detailed to them the FDA Act of 2009 and discussed the role of its officials and staff. The act strengthened and rationalized the regulatory capacity of what was then known as the Bureau of Food and Drugs—enabling the agency to establish more testing laboratories and field offices, upgrade its equipment, and augment its human resources complement. It also gave the new FDA authority to retain its income.

Dr. Hartigan-Go also explained the importance of FDA’s role for the tourism, trade, national security, national competitiveness, and to public health.

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In another session, Health Secretary Enrique Ona briefed them on the implementation of the government’s universal health care program or Kalusugan Pangkalahatan.

Sec. Ona explained the four major pillars of the program—health insurance coverage for all Filipinos, the improvement of Department of Health (DOH) and local government unit’s (LGU’s) hospitals and health facilities up to the rural health centers, public health as a priority for the millennium development goals (MDGs), and an up-to-date computer system, which is vital for faster transmitting of information to the barangays.

Meanwhile, World Health Organization’s Western Pacific Regional Office (WPRO) headed by Dr. Shin Young-Soo, regional director, discussed the following topics: overview of regulatory functions for medicines and health product; models of effective food safety regulatory systems; regulation of vaccines; ensuring quality and safety of traditional and complementary medicines; and comparison of different models of food and medicines regulatory systems.

WHO expressed their confidence that Mongolia can adopt an effective system that is fit for the needs of their country. WHO also assured technical assistance to Mongolia and suggested to underscore the scientific and practical aspects of setting up a drug regulatory agency while maintaining its integrity. The agency will be under the MOH, which is responsible for public safety.

Capping their study tour was a dialogue with DOH Undersecretary of Health for Administration Technical Cluster, Dr. Nemesio Gako; director of DOH Procurement Office, Dr. Ma. Theresa Vera; and staff members of the National Center for Pharmaceutical Access and Management (NCPAM).

Topics discussed were the Philippine Medicines Policy, drug selection process, process of centralized procurement of drugs in the DOH, and process of bulk drug procurements for the government by the PITC Pharma Inc.

Delegates were informed that the effective way to lower the cost of the medicines is by bulk procurement following a projected plan of delivery for each project of the DOH.

This way, limited available storage of the government would be maximized; thus, resulting to a coordinated distribution of medicines. Gelyka Ruth R. Dumaraos

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VitalSigns Issue 63 Vol. 3, May 1-31, 2014