[Contribution] On MFDS’s new drug approval fee hike

 Kyung-won Seo, Chair Professor, Department of Food& Medical products Regulatory Policy, Dongguk University

 Kyung-won Seo, Chair Professor, Department of Food& Medical products Regulatory Policy, Dongguk University

The Ministry of Food and Drug Safety recently announced a significant rise in its new drug approval fee to KRW 410 million.

 

In Korea, the new drug approval fee had remained very low at KRW 8.83 million for decades, compared to the US FDA's KRW 5.3 billion, the European EMA's KRW 490 million, and the Japanese PMDA's KRW 430 million.  The fee hike had been long desired by the industry and the MFDS alike, and the MFDS had worked hard to raise the fee.

 

So the significant increase in the new drug review fee means that the value of the new drug review work being carried out by the authorities has been properly recognized, which the MFDS and the MFDS members in charge of new drug approvals should be proud of.

 

Congratulations and a big round of applause to MFDS for their hard work and this long-awaited achievement.

 

Since a new drug is a substance that has never been administered to humans before, the development company must conduct extensive experiments to confirm the quality, safety, and effectiveness of the new drug, and regulatory authorities must evaluate the adequacy of its process and results.

 

The process of reviewing new drug data requires a large number of experts from regulatory agencies and takes more than a year, so the labor cost of this process is reflected in the new drug review fee, which renders the fee high.

 

The industry has been receiving the news with mixed emotions – welcoming the long-awaited increase of the new drug review fee but then panicking at the unexpectedly large increase.

 

As the industry will be paying a significant amount - KRW 410 million – it will expect high-quality regulatory services.

 

The MFDS’s announcement of the 'Innovative Plan for New Drug Approval' along with the administrative notice of the 'Fee Regulations for Drug Approvals, etc.' is an expression of its strong will to provide high-quality regulatory services that can meet industry expectations.

 

Until now, the biggest complaint of the industry has been the unpredictable review period/approval date of new drugs.

 

A particularly notable part of the MFDS’s innovation plan is that it will shorten the review period from an average of 420 business days to 295 calendar days.  Unlike other countries, the MFDS’s review period is calculated in working days and does not include the time spent by the company preparing the data, so the total review period was delayed by 420 days on average, even if the statutory deadline was not met.

 

If the review period for new drugs is shortened to 295 calendar days, the Korean public will benefit by using innovative new drugs with verified efficacy and safety sooner, and the industry will receive the greatest gift of all: predictability in their approval.  In order for the MFDS to meet the actual 295-day timeframe, it will need to recruit a large number of highly qualified reviewers with expertise, conduct a thorough prior review to ensure that supplemental requirements that require significant time to prepare do not arise during the review process and harmonize review regulations internationally to ensure that no data or tests are required only by MFDS.

 

As most of the delays had occurred due to requests for supplementary data that require a significant amount of time to prepare, to prevent this from happening, a thorough preliminary review should be conducted and a system put in place to prevent the application from being accepted if it lacks required data.  Once the application has passed the preliminary review, the 295-day review period promised by the MFDS must be met.

 

Looking more closely at the reasons for the delays in the review period for new drugs, it can be assumed that there are still test items and data that only MFDS requires, and the preparation of these materials by supplementation was a factor in the delay.

 

Since Korea became a member of the ICH, most of the guidelines have been internationally standardized, but there are still items that need to be improved, and this fee hike is the opportunity to harmonize the details of the review regulations internationally.  With the development of the pharmaceutical industry and the advancement of new drug evaluations, the number and volume of review materials have increased dramatically, and the depth and complexity of the contents have reached a level that is incomparable to the past.

 

So the reviewers of regulatory agencies who have to evaluate these materials are required to have the highest level of professional capabilities.  Although the MFDS has been making great efforts to secure these talents, it has not been able to secure competent reviewers at the level of advanced regulatory organizations due to various constraints.

 

Now that the new drug review fee has been raised to the level of advanced regulatory organizations, everyone is expecting that the MFDS will attract a large number of reviewers who own the best expertise.  The increase in new drug reviews is expected to open a new era where various review innovations begin to be introduced.

 

For the new system to take off and succeed, the MFDS, industry, and academia must continue to communicate, coordinate, and improve the system through open discussion.  The MFDS has been working with many partners, including the industry, to become an advanced regulatory organization.

 

I expect that the MFDS will continue to move forward step by step with its long-standing partners to become the world's leading regulatory agency, and I extend my warmest support to the MFDS as one of its former members and now one of its most enthusiastic supporters.