The Minister Lee, Enhanced post-de-factor management

"15 years follow-up in 3000 patients injecting Invossa at 20 medical institutions"

Strengthen practical use of RWD (Real World Data), "R &D investment extension"

Recognizing concerns about conditional phase3, will announce strengthening safety policy

Lee Eui-kyung, the Minister of MFDS has released a long-term follow-up plan to strengthen the post-de-factor safety management system.

 

On the 15th, the Minister Lee attended Korean Academy of Social & Managed Care Pharmacy and presented the four directions of drug safety management in four categories: patient safety, accessibility, safety ecosystem, and globalization.

 

In particular, the Minster Lee emphasized that she will lead to a paradigm shift centered on patients by strengthening post-de-factor management.

 

She said, "In the meantime, in the event of Invossa’s case , it was most of the time that the license was revoked or changed.

 

In the future, we will thoroughly control the side effects, operate the long-term follow-up management system, and carefully regulate the damage.

 

I will lead the paradigm.

 

" For 3,000 patients for injecting Invossa, she will select 20 medical institutions and conduct a long-term follow-up survey for 15 years.

 

"We have registered for 80 to 90 percent of our patients." she said, "Patients have used 400 medical institutions, but the concern is about cancer.

 

So long-term follow-up should be in a hospital with oncology." "We plan to track them all at large hospitals, and we will also carry out causality research of cancer." On this day, the “Long-term patient tracking survey system (Draft)”, which will be applied to future risk medicines, was announced.

 

According to the plan, when the MFDA issues a follow-up order, companies make a plan and MFDA goes through approval process.

 

Companies conduct follow-up investigations.

 

Causality evaluations and follow-up actions are conducted with the MFDS.

 

The Minister Lee said, "We still have to be specified liability compensation.

 

The government thinks that product defects should be shouldered by pharmaceutical companies.

 

But, pharmaceutical companies have different positions that they are not responsible for what they didn't know at the time.

 

We are discussing the responsibility with the relevant committees” ◆Strengthen practical use of RWD (Real World Data), R &D investment extension.

 

In addition, MFDS will strengthen the use of RWD (Real World Data) and RWE(Real World Evidence) next year to strengthen patient safety management It plans to establish big data utilization system such as clinical site RWD and RWE in clinical trial RCT.

 

To this end, it will actively invest in R & D costs.

 

She said, “We will make an official announcement in January about the plans for using big data.

 

MFDS R & D expenses rose from ₩85 billion to ₩100 billion this year.

 

But most of them are the cost of experimentation.

 

I'm going to turn this into RWD study”.

 

She also announced that she will soon disclose ways to improve safety for conditional phase3 permits.

 

"There is a lot of controversy about whether a conditional phase3 permit will guarantee the patient first, or if he will give the opportunity after ensuring full safety, if there is no alternative." We will soon release to the media on how to make it work more securely.

 

” ◆As new drug development countries become more important, permit strengthening of MFDS expertise She said that as Korea is actively developing new drugs, licensing is becoming more important, so the MFDA will also strengthen its expertise.

 

She said, “If the drugs were reviewed at least once because foreign new drugs were introduced into the country in the past, currently there is a need to be more burdensome in terms of initial authorization and to reinforce professionalism since new drugs are being developed in Korea.

 

Only about 350 people are screened by the MFDS, but there are 6,000 Ph.D in US.

 

The MFDS will focus on strengthening its expertise in the future.” She also said “MFDS or pharmaceutical companies can’t do it alone, Infrastructure maturity must increase” "The long-term policy is needed to fundamentally improve the problem," She said.

 

It is true that there is a lack of policy research think tank, ” She also recognized the necessity of analyzing and evaluating the future system.