Implementing QMS at DDA to Become WHO listed Regulatory Authority

With support from USAID’s MTaPS program over the past four years, Nepal’s national medicines regulatory authority, the Department of Drug Administration (DDA), has taken a series of steps to transform itself into a more efficient and effective institution that is capable of managing their complex mandate of ensuring the safety, effectiveness and quality of all pharmaceutical products in the country. One major achievement is the establishment of a Quality Management System (QMS) at DDA- a long-term goal that enables them to be listed as regulatory authority by the World Health Organization (WHO). This was a huge task. The DDA had to train their regulatory staff and update, create and or/revise all relevant policies, standards, processes, job descriptions, and tools to enable the QMS to function properly. The DDA and MTaPS used the Collaborating, Learning, and Adapting (CLA) approach that combined cross-departmental collaboration within DDA and external coordination with national and international partners; the creation of new opportunities for formal and informal learning to build staff capacity, and; the building of consensus on what and how to adapt, revise and upgrade existing policies, procedures and systems to fit international/WHO standards and meet current challenges and needs.

USAID MTaPS is a five-year (2018-2023) global program implemented in 18 low- and middle-income countries to strengthen their pharmaceutical systems. MTaPS is implemented by a consortium of partners led by Management Sciences for Health from Sept 20 2019 to Sept 19 2023.