New drug approval fees ₩410mil in KOR

10 substances apply for new drug approval

Review in progress for 6 chemical drug substances and 4 biological drug substances

A total of 36 spots set apart for high competency reviewers…with 31 positions filled with public official appointments

Since the new drug approval fee was significantly increased to KRW 410 million starting this year, a total of 14 new products containing 10 ingredients have been submitted for approval.

 

Although the specific product names cannot be disclosed, dedicated teams have been formed for 6 chemical drug substances and four biopharmaceutical substances, and the review process is currently underway.

 

On the 12th, Young-joo Kim, Director of the Drug Approval Division at the Ministry of Food and Drug Safety, So-hee Kim, Director of the Director of the Cardiovascular Drug Division of the Drug Review Department, and Jae-ok Kim, Director of the Biological Products Division of the Bio and Herbal Medicine Review Department, met with specialized media journalists to provide an interim briefing on the new drug approval and review innovation process that began this year.

 

, Young-joo Kim, Director of the Drug Approval Division at the Ministry of Food and Drug Safety, So-hee Kim, Director of the Director of the Cardiovascular Drug Division of the Drug Review Department, and Jae-ok Kim, Director of the Biological Products Division of the Bio and Herbal Medicine Review Department

On January 1, the MFDS raised the new drug approval fee to KRW 41 million, formed dedicated teams for each item, expanded face-to-face consultations and reviews between companies and approval reviewers for items submitted for approval to a maximum of 10 times, and shortened the manufacturing and quality control evaluation and actual condition survey of new drug manufacturing facilities (to within 90 days).

 

The increased approval fees were to be used mostly to hire high competency reviewers, and the MFDS has established a policy to operate a professional, swift, transparent, and predictable approval review system so that the process from new drug approval application to license issuance can be completed within 295 days.

 

The new drug approval and review process begins with a pre-submission consultation, followed by the submission of a product license application.

 

A dedicated team of approximately 15 members is then formed for each product.

 

Actual meetings begin within 2 weeks of the submission of the application.

 

GMP inspections for new drugs are also completed within 90 days of the submission date.

 

On January 31, multinational pharmaceutical company Eli Lilly applied for marketing authorization for its new breast cancer drug “Inluriyo Tab (imlunestrant),” and a total of 10 substances are currently under review.

 

While actual marketing authorizations are not completed in the order of application submission, for Inluriyo, if the innovative approval scheme for new drugs is applied, approval could be granted as early as November or by December at the latest.

 

Director Young-Joo Kim stated, “While I cannot comment on the approval process for specific products, we are striving to complete the approval process within 295 days from the date of submission of the marketing authorization application in accordance with the new drug approval and review procedures.

 

Despite the increase in new drug approval fees, we anticipate that the number of marketing authorization applications submitted will be similar to previous years.” As of August, applications for new drug approvals for 10 ingredients have been submitted, and based on the usual number of applications, applications for 20 ingredients were submitted in 2023 and 19 ingredients in 2024.

 

The MFDS believes that if this trend continues, the number of item approval applications will remain similar to those of previous years.

 

Kim added, “Until last year, when requests for supplementary data were made, everything was handled via documents.

 

However, now, there are over 10 face-to-face meetings from preliminary consultations to supplementary data submission requests, and all of this process is documented.” However, despite the significant increase in fees, only 15 to 17 dedicated staff members are being assigned to expedite approvals.

 

This is why, when a meeting is held regarding supplementary materials, everyone has to gather for a meeting lasting over an hour and a half.

 

Director Jae-ok Kim explained, “One hour and a half may seem short, but when supplementary materials are submitted, pharmaceutical companies also select the points they want to focus on and ask questions.

 

The meeting lasts about an hour and a half, with the purpose of the supplementary data request being explained and any questions being answered.” In the case of new drug approval fees, most of the increased amount will be used to cover the pay of high competency reviewers.

 

Currently, there are 31 high competency reviewers hired specifically for the new drug team, which is close to the total quota of 36.

 

The new drug dedicated team is composed of a team leader who is the head of the approval department, a product manager from the approval department, and specialists in safety and efficacy, quality control, GMP (good manufacturing practice), and GCP (good clinical practice), rendering the need to reinforce the specialized review staff.

 

Director Young-joo Kim said, “With the increase in new drug approval fees, the cost of review is borne by the beneficiaries.

 

The MFDS has a total of 370 reviewers, including those for medical devices, and about 10% of them are high competency reviewers.” However, as high competency reviewers are hired as public employees rather than civil servants, it is difficult for them to provide stable service.

 

As a result, they may only receive training on high competency review techniques and move to other organizations within a few years.

 

Director Jae-ok Kim added, “The current review staff is going through a transitional period.

 

High competency reviewers cannot be immediately deployed; they must first undergo training, work as assistant reviewers, and then transition to head reviewers." He also pointed out that “this process is causing an overload of work for existing review staff.” Director So Hee Kim also emphasized, “Since the system is still in its initial stages, mid-level managers are facing significant challenges.

 

While hiring high-skilled reviewers is important, expanding the pool of personnel capable of fulfilling mid-level management roles is also necessary.” In this regard, Director Young-joo Kim said, “It is important to enable high competency reviewers hired as public officials to be appointed civil servants,” adding, “We plan to consult with other ministries and request that the number of civil servants be continuously increased.” Although the MFDS is applying the new drug approval fee hike only to new drugs, it plans to gradually expand it to other items.

 

President Jae-myung Lee's remarks also support this stance.

 

At a recent cabinet meeting, the president stated, “Insufficient review costs and a shortage of personnel are causing delays in new drug approvals, which is a loss for society as a whole.

 

Increasing review costs is a way to expand the budget without increasing the financial burden.” Director Young Joo Kim said, “The MFDS understands that the intention is not to further raise the new drug approval fees, but to expand the fees to items other than new drugs to increase revenue.

 

We are in ongoing discussions with government ministries and related industries on items for which fees can be raised based on principles such as the novelty and complexity of the substance.”