The MFDS consulted on Expedite Approval of COVID-19 PO

Discuss the scope and schedule of data submission, and the government will introduce it in February next year

The MFDS announced that it is conducting consultations with the company for rapid domestic approval on overseas developed COVID-19 oral treatments on the verge of commercialization.

 

In the case of Molnupiravir, an oral treatment for MSD, the government plans to gradually introduce 404,000 people through a pre-purchase contract in February next year, which is expected to speed up discussions on the introduction of overseas COVID-19 treatments in Korea.

 

Kim Mi-jung, head of the pharmaceutical standards division at the MFDS, briefly met with reporters at Osong on the afternoon of the 9th and made the announcement.

 

Kim said, "In the case of oral treatments of MSD and Pfizer, we are conducting consultations on the scope and schedule of data submission for Expedite Approval," and explained, "However, actual data are not received." Kim added, "In principle, we plan to conduct safety, effectiveness, and quality screening for COVID-19 treatments," adding, "We plan to review them quickly when data are received." Prior to this, Kang Sung-sik, vice president of Pfizer Pharmaceutical's medical department, said at the 2021 Pfizer Press University held online on the 8th, "We are in close consultation with regulatory authorities including the MFDS." Paxlovid is expected to show that the hospitalization and death rate decreased by 89% compared to placebo when taken within three days of symptom onset as a result of interim analysis of phase 2 and 3 released on the 5th.

 

MSD's oral treatment, which the government declared in February next year, also reduced the risk of hospitalization and death by about 50% as a result of a phase 3 interim analysis.

 

Britain approved Molnupiravir, for the first time in the world on the 4th.

 

As Korea promised to introduce it in February, it is expected to speed up its approval review.

 

However, if the submission of data is delayed, it is highly likely to be introduced in Korea through procedures such as Expedite Approval.

 

Kim said at a briefing that day, "Since the enforcement of the Data Limitation Act in July, the submission of a biological equivalence test plan has increased 2.5 times more than usual." Kim said, "If next year's result report is submitted, the MFDS will have more work." In addition, Kim said that she established a "comprehensive evaluation team for constant evaluation of impurities" consisting of about 20 people to prepare impurity evaluation technologies through information sharing with overseas regulators, as well as determine the cause.

 

However, she added that there are no additional impurity issues other than the three Sartan types, which were decided to be recovered due to impurities in Azido in September.

 

She is also considering recruiting about 50 people due to the expansion of overall permit screening work.