Ministry of food and drug safety

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[Press Release, Nov 22, 2020] MFDS decides to cooperate with WHO in COVID-19 Vaccines PQ Evaluation Activities
  • Registration Date 2020-11-20
  • Hit 173
[Press Release, Nov 22, 2020 / unofficial translation ]

MFDS decides to cooperate with WHO in COVID-19 Vaccines PQ Evaluation Activities

□ The Ministry of Food and Drug Safety (MFDS, Minister Kim Ganglip) announced the participation of its staff as reviewers in the World Health Organization’s (WHO’s) Prequalification (PQ) of COVID-19 vaccines that will be supplied through the COVAX Facility, a multinational alliance created to support an equitable distribution of vaccines, and other international vaccine suppliers.

○ WHO conducts PQ evaluation to assess the quality, safety, and efficacy of vaccines and other medical products for international procurement. All medical products need to be prequalified to be invited to the bidding for international procurement.

- COVID-19 vaccines intended to be supplied through the COVAX facility will also be prequalified by the WHO.

[WHO PQ Process]
√ PQ is a program provided by WHO to assess the safety and efficacy of medical products intended for international procurement to developing countries. The assessment also takes the safety management capacity of the manufacturing country’s regulatory authority into consideration.
√ Process (5 components): Invitation (Submission of Application) → Dossier submission (data on ingredients used in manufacture, the finished pharmaceutical product, clinical trials, etc.) → Assessment (evaluation of all the data presented) → Inspection (verify that the manufacturing sites and competent authorities comply with WHO’s good manufacturing practice, good clinical practice and good laboratory practice, etc.) → Decision

□ MFDS has participated in WHO PQ since 2012 as WHO has acknowledged the competency of MFDS in the regulation of vaccines. Ever since MFDS signed an arrangement on “collaboration in the prequalification process” in 2016 and a mutual confidentiality arrangement with WHO in 2017, it has provided technical supports to the Korean vaccine manufacturers for WHO PQ.

□ Through the participation of MFDS in WHO’s PQ of COVID-19 vaccines, Korea will be able to make substantial contribution to the global efforts to fight against COVID-19 pandemic.
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  • [최종]영문보도자료_201122_WHO코로나백신PQ평가참여_eng_식약처.pdf Download

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