What is the solution for Remdesivir/generic competitiveness?

Challenges since COVID-19, communication issues with the pharmaceutical industry

Kim Young-ok, director, considering non-face-to-face environment, generic competitiveness policy

Kim Young-ok, director of pharmaceutical safety bureau at the MFDS

There was no communication between the MFDS and the pharmaceutical industry due to the COVID-19 crisis that began in Korea from the end of January.

 

Since the 'Director of pharmaceutical safety bureau at the MFDS-CEO Meeting in 2020' was postponed indefinitely on February 12, the news of the MFDS was only occasionally available through data and articles.

 

The 'Online Video Conference between the MFDS and the factory managers in the pharmaceutical industry' held on the 2nd and 9th attracted attention as it was a place of communication after a long time.

 

The MFDS says it will continue to expand such non-face-to-face video conferencing and investigation.

 

Officially met with reporters this year, Kim Young-ok, director of pharmaceutical safety bureau at the MFDS, also selected keywords of the MFDS as a solution to non-face-to-face environmental changes and generic competitiveness measures after the COVID-19 outbreak.

 

In addition to the reporter's meeting with director Kim Young-ok held on the 16th, there was also a story about the homework facing the MFDS in COVID-19 crisis.

 

These include, for example, special imports of Remdesivir and clinical trials of COVID-19 treatments.

 

The following is a summary of the meeting with Director Kim Young-ok.

 

After COVID-19 incident, how will the factory survey be conducted? "As the non-face-to-face environment becomes common, it is inevitable to change.

 

Some are already doing so.

 

For example, if there is a due diligence report from the PIC/s member countries, it replaces the actual investigation.

 

I'm going to try a method that I can see even if I don't go, and I think I can connect to the company and employees through video equipment to look at facilities, equipment, etc.

 

Korea has good IT technology and networks, If it goes well, I think these things will be enlarged and become everyday." Will the policy briefing sessions proceed in a non-face-to-face manner in the future? "I recently had a videoconference with the factory manager of a pharmaceutical company, and I plan to expand it in the future because it was a place where I could communicate with the field without face-to-face.

 

There are several technical and unfamiliar parts.

 

There are many effective aspects.

 

The policy briefing session is also looking for ways to make it non-face-to-face, and it is also considering ways to post content on Youtube and so on, so that it does not end in one time.

 

Counseling is also being prepared so that the videoconference can proceed as much as possible." In this non-face-to-face situation, can clinical trials of COVID-19 treatment be conducted properly? "The clinical trials for new drug development should also prepare for system maintenance according to non-face-to-face.

 

Change has already begun..

 

In the case of COVID-19 treatment, it is difficult for clinical trial operators to contact and even obtain consent.

 

The agency has made improvements to ensure that clinical trials can be carried out smoothly.

 

As a result, 12 clinical trials related to COVID-19 treatment and 2 vaccines have been approved." How is the public-private partnership to strengthen the competitiveness of generic drugs? Paradoxically, international confidence in medical products in Korea has been increasing a lot since COVID-19.

 

I think Korean medicine should enter the global market with this opportunity.

 

It is discussing strengthening international competitiveness of generic drugs through public-private councils in this regard.

 

There are two main objectives.

 

The first is to provide accurate information to the people, and the second is to make 'K-Generic' grow into the future industry.

 

In order for these things to work, we need to help them enter the global market.

 

The MFDS is planning to proceed with international cooperation with local governments so that Korean companies can obtain product approvals quickly from overseas countries.

 

The public-private council plans to announce the final conclusion in late June." How is the cause of NDMA detected in Metformin being investigated? “We plan to draw a final conclusion through the NDMA investigation committee.

 

We are investigating with the manufacturer with the detected item.

 

We went through due diligence to understand the situation.

 

When the data is gathered in the committee, it seems that scientific conclusion will be reached.

 

However, it seems difficult to complete the cause investigation within a short period of time because there are various facts (causes) in the process.” How is the discussion of accident compensation due to the NDMA case going on? "This issue is also being discussed through the public-private council.

 

However, I think we should see the lawsuit result in the Valsartan case.

 

I intend to participate if it goes through legislative assembly with regard to personal contributions." How is the proceedings of special import for Remdesivir going? "We are in the process of discussing with Gilead and the KCDC.

 

The timing and quantity of supply will be decided in a consultation process.

 

Gilead is also actively negotiating.

 

These drugs need to be approached in that respect because the company has more publicity than taking private profits.

 

Gilead knows well." Isn’t the reevaluation of Choline alfoscerate formulations too late? “We are going at our own pace.

 

The schedule of the MFDS was in June, and it seems to be going as it was.

 

In the meantime, there were data limitations, and thus, manufacturers were asked for additional data.

 

Some experts reviewed it internally, and some evaluations were conducted by the evaluation agency.

 

Currently, Pharmaceutical Affairs Review Committee’s meeting is scheduled to be held and it will be asked if a special reevaluation is appropriate.

 

If a special reevaluation is conducted, it is planned to seek advice on how appropriate it is.

 

When the results are announced, we will take steps to organize the position of the MFDS and publish it soon.

 

However, the Committee is not a deliberative body, but an advisory body.”