The National Institute of Food and Drug Safety Evaluation under the Ministry of Food and Drug Safety (Minister: Kim Seung-hui) announced that it has been officially designated as a "Global Learning Opportunities for Vaccine Quality (GLO/VQ)" by the World Health Organization.

The GLO/VQ is a program designed by the WHO where training is conducted to help regulatory authorities and vaccine manufacturers, etc. secure the safety and efficacy of vaccines. GMP, GCP, lot release, etc. are taught as part of this program.

The national lot release is a mechanism where, prior to products being marketed, lot release tests, manufacturing and quality control summary data are reviewed for every lot by the NIFDS.

The designation, this time, is for the vaccine national lot release - a core element of vaccine quality control, and the first field of training designated by the WHO was in quality (GMP) back in 2007.

The WHO first recognized the excellence of international vaccine lot release training sessions that were being offered by the NIFDS since 2012, and a designation decision came after visits to the institute and evaluation of relevant documents, of which took roughly two years in total.

Six regulatory officials from five countries in 2012, eight officials from six countries in 2013, seven officials from seven countries in 2013, and eight officials from seven countries in 2015 took part in the training offered by the institute.

The WHO has in operation training centers in manufacturing quality, clinical studies, national lot release, etc., targeting vaccine manufacturers and national regulatory authorities.

The NIFDS, since its designation as the fifth WHO Collaborating Center for biological standardization and evaluation in 2011, has been working closely with the international organization in developing international medical standards and strengthening national regulatory authorities.

National regulatory authorities that have been designated by the WHO as a standardization and evaluation collaborating center are as follows (sequential order): NIBSC (UK), NIID (NIID), TGA (TGA), FDA/CBER (U.S.), NIFDS (Korea), Health Canada (Canada), NIFDC (China), PEI (Germany).

Since 2006, by signing TSA with the WHO as one of the internationally-accredited external laboratories, the NIFDS has been conducting quality conformity assessment for vaccines to be provided to the UNICEF and other international organizations.

The institute added that it will contribute to enhancing Korea's vaccine international standing and competitiveness by exerting more efforts towards improved international cooperation with organizations such as the WHO.

Press Release, Feb., 24, 2016