MANILA - Partnership between WHO and the Ministry of Food and Drug Safety (MFDS) of the Republic of Korea continues to grow in supporting Member States to effectively regulate biomedical products.
The National Institute of Food and Drug Safety Evaluation (NIFDS) of the MFDS is a WHO collaborating centre for biological standardization and evaluation. Building on good collaboration with WHO since 2011, the MFDS awarded US$ 5 million to WHO for 2015 to 2019. This award will assist WHO in implementing new guidelines in countries in the Western Pacific Region. The five-year official development assistance (ODA) project will provide training, technical advice and upgrades to laboratory equipment as well as rehabilitation of laboratories in Cambodia, the Lao People's Democratic Republic, Mongolia and Viet Nam.
This ODA project will strengthen six critical functions of national regulatory authorities for vaccines: 1) an appropriate approval system; 2) national lot release; 3) laboratory access; 4) good manufacturing practice inspections; 5) post-approval surveillance; and 6) clinical trials.
The MFDS has provided a variety of support to Member States in the Western Pacific Region and beyond. In 2015, MFDS experts were invited to the Philippines by the Food and Drug Administration to support the national regulatory authority (NRA) assessment. They were also invited by Cambodia's Ministry of Health to observe their NRA's assessment. In 2016, the MFDS supported the NRA assessment in the Ministry of Health and Sports in Mongolia.
As a WHO Global Learning Opportunities Centre, the MDFS provides lot release and good manufacturing practice (GMP) training. Since 2006, the MFDS has worked with 98 trainees from 22 countries to complete GMP inspector training. In 2015, participants from Bangladesh, Colombia, Ecuador, Indonesia, the Philippines, Peru and Thailand completed lot release training. Participants from Cambodia, the Lao People's Democratic Republic, Mongolia, the Philippines and Viet Nam completed training in use of equipment for vaccine quality control. These trainings are scheduled to be offered again in 2016.
The Head of the NIFDS/MFDS, Dr Yeowon Sohn, commented on the upcoming second forum of WHO collaborating centres in November 2016: "the forum will be an opportunity to share our experiences in supporting WHO's Member States and to learn from other centres and the WHO Secretariat how we can continue to ensure the support we provide meets their needs".