MFDS Minister promises COVID-19 vaccineˑTx support

The Minister of Food and Drug Safety Yoo-Kyung Oh met with COVID-19 vaccine and treatment developers and relevant associations and promised support in the future.

 

On the 29th, the MFDS held an MFDS-Industry roundtable meeting for the COVID-19 vaccine-treatment development support.

 

The meeting was held to discuss the difficulties experienced by developers in conducting clinical trials and MFDS’s measures of support in situations where the development of a homegrown vaccine or treatment becomes imperative due to an epidemic.

 

At the event, the MFDS introduced its measures for support in commercializing such products, listened to the difficulties that the industry experienced in the process of developing COVID-19 vaccines, and discussed measures of MFDS support for the development of vaccines and treatments.

 

Minister Oh said, “Korea is an established leader in the pharma-bio sector that owns both a vaccine and treatment for COVID-19.

 

The MFDS will continue to innovate regulations in the field to support the rapid commercialization of homegrown COVID-19 vaccines and treatments." Also, Oh mentioned that it has been linking development-non-clinical trials, clinical trials-approval & review processes while providing professional support on clinical trial design through the commercialization strategy support task force that had been established in April.

 

Minister Oh said, “We plan to seek more efficient operation of the approval and review process for COVID-19 vaccines and treatments through rapid review, rolling review, etc.

 

while thoroughly reviewing their efficacy and safety through close review and expert advice." Companies and related associations that participated in the meeting expressed their gratitude to the MFDS for enabling easier export of products upon domestic approval, which has advanced its regulations through safety-based regulatory innovation and commercialization support efforts and asked for the ministry’s continued support for rapid vaccine development against variants and clinical trial subject recruitment.

 

The companies said, “It is imperative that the MFDS recruits more review personnel to enable rapid development of the second, third homegrown vaccines and treatments.

 

We ask the MFDS to increase their review personnel and strengthen its expertise.” The MFDS expects the meeting to help identify various difficulties experienced in development and come up with support measures.

 

The ministry added it will do its best to support the rapid development of domestic vaccines and treatments by operating programs specialized for COVID-19 and commercialization strategy support teams - such as ‘Our Vaccine Project’ and the ‘Development-focused support council’ - for the prompt development of homegrown vaccines and treatments.