MFDS requested supplementary data of Mifepristone

'The MFDS is conducting a comprehensive review including the need for Bridging Study data.

 

A year and four months have passed since the abortion crime was abolished, but drugs that have been applied for permission by domestic pharmaceutical companies are still being reviewed.

 

According to the press release of the MFDS on the 18th, the MFDS requested the submission of supplementary data of Mifepristone applied by Hyundai in July last year.

 

The MFDS said, "We asked the company to submit supplementary data because we needed to supplement some data during the screening process, and the company has requested a postponement of the deadline for submitting supplementary data." At the Central Pharmaceutical Review Committee held last year, the need for a Bridging Study clinical trial to verify safety and effectiveness by conducting clinical trials on Koreans again was discussed, but the MFDS has yet to give specific opinions.

 

At the time, the Korean Association of Obstetrics and Gynecology said that the Bridging Study should be conducted, but most members reportedly concluded that the Bridging Study clinical trial was unnecessary.

 

Accordingly, the MFDS said, "We are comprehensively reviewing the data submitted by the company, including whether or not bridging study data is necessary," adding, "It is difficult to answer because the approval schedule cannot be predicted." Regarding the criticism that obstetricians and gynecologists were excluded from the committee, the committee held last year said that obstetricians attended the committee as members The MFDS explained, "When the Central Pharmaceutical Center was held, obstetrics and gynecology specialists were also present as members in accordance with related regulations, and the Korean Association of Obstetrics and Gynecology attended and submitted opinions." Regarding the drug item license and safety use plan, the MFDS said, "Check safety, effectiveness, and quality, and use it safely during the examination process, and we will come up with measures such as educational materials for experts and patients and post-marketing investigations to ensure that abortion drugs can be used in a legally stable environment, and we will actively support the National Assembly's law revision process.

 

On April 11, 2019, the Constitutional Court made a constitutional nonconformity decision on the abortion of the criminal law to respect women's right to self-determination of the body, and the abortion crime has been invalidated since January 1 last year.