The Ministry of Food and Drug Safety has completed preparations to raise the fee for new drug approvals to KRW 410 million from January 1 next year.

Since mid-October, the agency has formed the ‘Consultative Body for Discussions on New Drug Approval and Review Procedures' and completed the 'New Drug Approval and Review Business Procedures (Guidelines for Officials)' after 4 meetings.

The MFDS expects the increase in new drug approval fees to be the first step towards improving the system to the level of the U.S. FDA and the European EMA.


The MFDS press corp recently met with Director Young-Joo Kim, Head of the Pharmaceutical Approval Management Division at MFDS; Director Chung-Rae Kim, Head of the Pharmaceutical Policy Division at MFDS; and Director Sang-Ae Park, head of the Pharmaceutical Standardization Division at the National Institute of Food and Drug Safety Division to learn more about the 'Notification of Partial Amendment to the Fee Regulations for Approval of Pharmaceuticals, etc.' that was announced on the 8th of last month.

The following is the Q&A transcript of the meeting.

▶ The MFDS issued an administrative notice of the proposed revision from September 9 to November 8, and in the process disclosed the business procedures for approving and reviewing new drug items. What progress has been made since then?

“In October, we created a council to discuss the new drug approval process. A total of 32 people, including 8 from the Ministry of Food and Drug Safety, 6 from the Korea Pharmaceutical and Bio-Pharma Manufacturers Association, 9 from the Korean Research-based Pharmaceutical Industry Association, 3 from the Korea Pharmaceutical Traders Association, and 6 from the Korea Biomedicine Industry Association, took part in the council. Various discussions were made during the meeting, starting with a moratorium on fee hikes. After 4 meetings to collect opinions, the final guidelines were created. There was much industry input and I think we've reached something near of a consensus. The system is ready to be implemented.”

▶The KRPIA had strongly insisted on a moratorium on the fee hike last November, have you reached a consensus?.

Director Young-Joo Kim “The MFDS is on a level where we can show the approval process, transparency, and predictability of advanced regulatory agencies such as the FDA and EMA. We have fully discussed concerns through the council, and the KRPIA has no objection. Procedurally, we have increased the number of face-to-face consultations and allow GMPs to be performed within 90 days, and I think this will be a step towards creating a system that can allow new drugs to be approved within 295 days. Some companies are already preparing for the increased fees. I think the KRW 410 million fee will be fully compensated by receiving approvals a month earlier.”

▶ You said that you had held 4 meetings, and it seems that the guidelines have changed somewhat after the meetings, such as the addition of a pre-registration process to provide supplementary materials to MFDS in advance during the first and second supplement request processes, and the allowance to request an explanatory meeting based on the submitted material.

Director Young-Joo Kim “As you can see from the table of guideline changes, slight changes have been made to the guideline. The biggest difference from the draft is the addition of the preliminary consultation session before fee payment to increase the predictability of the approval process before paying the fee. However, pre-consultations are limited to one session per item. Instead, we added more face-to-face consultations, so that each supplementation to their application can be consulted and reviewed in advance. In the past, there were many claims on how the MFDS makes unexpected supplement requests at the last minute. The goal is to increase predictability in this area. Through prompt communication, we aim to shorten the approval period by reducing unnecessary waste of time. We plan to also further the approval process by formally recording the minutes of our meetings. In general, by improving the transparency and predictability of the new drug approval review process, we hope to bring new drugs to market sooner, making the industry more competitive and enabling a faster supply of medicines.”

▶ How does the prior consultation process work?

Director Young-Joo Kim “In the case of new drugs, I think that companies that have already prepared enough data will proceed with the prior consultation session with the goal of applying for approval so that a dedicated team will be created from this stage. I can’t ensure the details as we haven't established the team yet, but the team will be decided based on which department should examine the safety, efficacy, and quality of each drug with consideration into the ingredients and efficacy, so we plan to proceed with a preliminary team dedicated to each item to allow the drugs to be approved. In the preliminary consultation stage, we will discuss the future schedule, the point of application submission, and the establishment of a dedicated team.”

▶ Are there any companies that have expressed their intention to apply for approval after the fee hike increase in January next year?

Director Young-Joo Kim "We are aware of some companies that have applied for approval. We are receiving inquiries for preliminary consultation from the companies. I cannot disclose the names of the companies, but there are several domestic and multinational pharmaceutical companies that have expressed their intention to apply for approval.”

▶You are aiming for 295 calendar days from application to approval. Do you think this can be achieved?

Director Young-Joo Kim “If there is a delay in the preparation of supplementary data, the period may exceed 295 days. This means that the term can be extended by the length of the extension period. However, we have created a lot of consultation processes to shorten the time for the companies’ supplement preparation. The goal is to shorten the time between the company preparing the supplementary data and the MFDS’s review of it as much as possible through consultation. Frequent communication with companies is expected to reduce the number of supplement requests and time consumption. It will be an opportunity to advance our system forward to a global-level review system.”

▶I understand that you are recruiting specialized reviewers for new drug approvals

Director Sang-Ae Park “We have been recruiting reviewers from the 13th to the 22nd. We are hiring reviewers as soon as possible and plan to finalize the recruitment process by January. We have actively promoted our recruitment through various channels such as college of pharmacies, academic societies, and social media.”

▶ I understand that the reviewers hired this time do not include doctors. It seems that physician reviewers will also be needed.

Director Chung-Rae Kim "This recruitment was made to recruit highly competent reviewers to add to our existing workforce. We opened the recruitment process to meet the need to increase the number of reviewers, and we will continue to recruit doctors and other experts periodically over the next year after completing the transition of the first- and second-level personnel. In addition, once the revision of the fee notification is finalized, we will increase the overall salary of our reviewers.”

▶ There will be some items that apply for approval in Korea for the first time, even before the FDA and EMA. Do you think the MFDS owns the capacity to approve them in 295 days?

Director Chung-Rae Kim "Korea was listed on the WLA last year and is a member of ICH. I think we should believe that the competence of our reviewers stands at a global level. If there is a shortcoming of the MFDS, it is in the difficulty of recruiting human resources. Even if the new drug is first to come to Korea, I think it will be possible to approve it if the manpower is reasonably replenished along with the fee increase and the number of highly competent reviewers is filled.”

Director Sang-Ae Park "I would like to emphasize that the increase in the new drug approval fee is just the start of our challenge. This is just the beginning. I don't think we can reach the FDA's review level in a short period of time, but we believe it is significant that the challenge has begun.”

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