The Ministry of Food and Drug Safety (MFDS) expects to receive certification as World Health Organization (WLA) Listed Authorities by the end of this year.
WLA is a system where WHO assesses and certifies the performance of drug regulatory agencies. This year, the global health agency introduced the system as a replacement for existing “strict regulatory authorities (SRAs)”.
When listed, the system will exempt Korean pharmaceutical companies from submitting to the WHO Prequalification Approval (PQ) tender for the procurement of medicines from UN-affiliated organizations, such as UNICEF.
Last year, the ministry assessed 268 indicators in nine areas: regulatory system, marketing authorization, pharmacovigilance, market surveillance, business license, regulatory due diligence, testing/inspection, clinical trial and national shipment approval for the WLA list.
Subsequently, the ministry became the first global regulatory agency to submit related data for approval to the WHO on January 28.
“WHO had made it a rule to go through the approval process for 14 months, but the agency said it would complete the assessment in a shorter time as Korea is the first country in the world to promote the WLA registration,” said Moon Eun-hee, director of the ministry’s Drug Policy Division. “Therefore, we expect the results to be published this year.”
According to the ministry, he received an on-site assessment from the WHO assessment team in May and will undergo an additional assessment in September or October.
“The remaining assessment includes the approval review process, clinical trial plan, quality test, and clinical trial status investigation,” Moon said. “After the final assessment, the WHO will give a final answer after an internal review.”
Moon pointed out that Korea is seeking to become the first country to appear on the WLA list because it was not included in its previous version, the SRA list.
“The WHO has listed 36 countries on the Strict Regulatory Authorities (SRA) list, including the US, Japan, UK, 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 member of ICH in 2016, WHO did not nominate SRA and decided to retain only original members.”
However, this year the WHO announced the launch of the WLA system, emphasizing that it would conduct its regulatory capacity assessment instead of the ICH assessment, Moon added.
Moon pointed out that if Korea completes WLA registration, other countries that could not obtain drug approvals on their own will likely introduce Korea’s drug registration system.
“We also hope that the WLA listing will help Korean pharmaceutical companies to export their product,” Moon said. “Also, since Korea is the first to go through the WLA approval process, several countries are monitoring our registration process.”
The ministry believes that once Korea completes its registration, other countries will likely push for registration as well, the official added.