RAI supports ISO accreditation of FDA Myanmar 15.04.2017

RAI supports ISO accreditation of FDA Myanmar

The Regional Artemisinin-resistance Initiative (RAI) grant is funding support to strengthen the capacity of the Myanmar Food and Drug Administration (FDA). This includes support to upgrade its National Reference Analytical Laboratory, to establish a vigilant drug quality monitoring system and for capacity building of national staff. 

Quality monitoring and testing of antimalarial drugs is important to detect fake and substandard drugs. Drug quality testing by an internationally accredited laboratory ensures accurate and reliable results for drug quality and safety, thereby protecting the Myanmar public.

In view of this, the Regional Artemisinin-resistance Initiative (RAI) grant is funding support to strengthen the capacity of the Myanmar Food and Drug Administration (FDA). This includes support to upgrade its National Reference Analytical Laboratory, to establish a vigilant drug quality monitoring system and for capacity building of national staff. Training activities include on quality management system, calibration of laboratory equipment, preparation of a country-level drug sampling and quality testing plan, and collection of drug samples for quality testing.

As accreditation of the testing laboratory is a prerequisite of PR-UNOPS quality assurance policy, until now UNOPS and FDA Myanmar have had to send samples of drugs collected regularly from across the country to TUV Singapore for quality testing. However, from now on, drugs can be tested here in the Myanmar FDA Laboratory, which is the first national FDA laboratory in ASEAN to be accredited by the United States-based ANSI-ASQ National Accreditation Board (ANAB).

This accreditation will increase confidence in FDA Myanmar among the local and international community and ensure availability of quality testing for anti-malarial drugs in Myanmar and countries of the Greater Mekong Sub-region (GMS).

There is an urgent need to tackle artemisinin resistance in GMS countries and the accreditation of the Myanmar FDA laboratory represents an important advance towards RAI’s goal to avert the spread of artemisinin resistance and accelerate elimination of P. falciparum malaria in Myanmar and the GMS.

While the Myanmar FDA Laboratory, was in the process of attaining ANAB accreditation for ISO/IEC 17025, a story about the process was featured on Myanmar television (MNTV). 

UNOPS is a Regional Principal Recipient for the RAI, which covers five GMS countries, including Myanmar, for the period 2014–2017 and with a total grant of US$ 124 million.