MPC, Toxicity-Efficacy Test Pre-review
Strict review of submissions for safety and effectiveness
[팜뉴스=이권구 기자] The Ministry of Food and Drug Safety announced on August 20 that MP Corporation had applied for a preliminary review before applying for a license for the Russian Corona 19 vaccine ‘CoviVac’.
Kobe Park is not a vaccine that the government has announced plans to introduce, and MP Corporation (MPC) has applied for a preliminary review of non-clinical (toxicity and efficacy test) data in accordance with the ‘Pharmaceutical Law’ regulations. The Ministry of Food and Drug Safety will closely review the safety and effectiveness of the submitted non-clinical data.
The Ministry of Food and Drug Safety plans to do its best to quickly supply safe and effective vaccines to the public.
Kovyvac is a vaccine developed by the state-run Chumakov Institute, a scientific research institute in charge of immune and biological research and development at the Russian Government Academy of Sciences. It has been developed as a vaccine that induces an immune response by injecting it into the body) and is evaluated to have greatly reduced the risk of side effects.
After securing reliability such as immunogenicity in preclinical and clinical phases 1 and 2, and after completing phase 1/2, it was approved for emergency use in Russia in February of this year.
A large-scale phase 3 clinical trial is currently underway in Russia.
In this regard, it is known that key personnel, including the director of the Chumakov Institute, visited Korea in March to review the production facilities through a visit to a famous domestic vaccine manufacturer, and discuss production and related technical issues. In addition, following the keynote remarks by the head of the research center Chumakov at the ‘Conference for Preparing Optimal Response Plans for Viruses in the Post-Pandemic Era’ held in Korea in June, the deputy director and senior researchers announced the development of inactivated vaccines.
Mp Corporation, which applied for the casting review this time, signed a main contract to acquire a 37.5% stake in ‘Pharm Bio-tech’, a Russian company that has the global copyright and exclusive production rights for ‘Kobi Park’ on July 1st, is known to have obtained.
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