The Ministry of Food and Drug Safety (MFDS) expects to receive certification as a World Health Organization Listed Authorities (WLA) by the end of this year.

WLA is a system where the WHO evaluates and certifies the performance of pharmaceutical regulatory agencies. This year, the global health agency implemented the system as a substitute for the existing "Stringent Regulatory Authorities (SRA)."

When listed, the system will exempt Korean pharmaceutical companies from undergoing the WHO's prequalification (PQ) approval bidding for procurement of medicines to U.N.-affiliated organizations, such as UNICEF.

Last year, the ministry evaluated 268 indicators in nine areas -- regulatory system, marketing approval, pharmacovigilance, market monitoring, business license, regulatory due diligence, test/inspection, clinical trial, and national shipment approval for WLA listing.

Afterward, the ministry became the first global regulatory agency to submit related data for approval to the WHO on Jan. 28.

"WHO had made it a rule to undergo the approval process for 14 months, but the agency said it would complete the evaluation in a shorter period as Korea is the first country globally to promote WLA listing," said Moon Eun-hee, director of the ministry's Pharmaceutical Policy Division. "Therefore, we expect results to come out within this year."

According to the ministry, it received an on-site evaluation from the WHO evaluation team in May and would undergo additional evaluation in September or October.

"The remaining evaluation includes approval review process, clinical trial plan, quality test, and clinical trial status investigation," Moon said. "After the final evaluation, the WHO will give a final reply after an internal review."

Moon stressed that Korea seeks to become the first country to be on the WLA list because it had not been included in its previous version, the SRA list.

"WHO put 36 countries on the list of Stringent Regulatory Authorities (SRA), including the U.S, Japan, U.K., France, Germany, Croatia, Latvia, and Malta, members of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) before 2015," Moon said. "While Korea became an official ICH member in 2016, the WHO did not offer an application for SRA and decided only to maintain the original members."

However, this year, the WHO announced the initiation of the WLA system stressing that it would conduct its regulatory capacity evaluation instead of the ICH's evaluation, Moon added.

Moon stressed that if Korea completes the WLA registration, other countries that could not obtain drug approval on their own will likely introduce Korea's drug licensing system.

"We also expect that the WLA listing will help Korean pharmaceutical companies export their product," Moon said. "Also, as Korea is the first to go through the WLA approval process, several countries are watching our registration process."

The ministry believes that after Korea completes its registration, other countries will likely also push for listing, the official added.