How will the new drug review process change with fee hike?

New drug approval fee is raised to KRW 410 million

A dedicated new approval review team established...will prioritize GMP-GCP on-site inspections

Aims to dramatically reduce the approval period from 420→295 days

The Ministry of Food and Drug Safety (MFDS) announced plans to raise the fee for new drug approvals to KRW 410 million from January 1 next year.

 

The agency has prepared the approval and review process to implement the plan and has begun collecting industry opinion.

 

According to MFDS’s press corp coverage, the MFDS recently delivered a revised version of the “Operating Procedures for Approval and Examination of New Drug Products (Guideline for public officials)” to the pharmaceutical and biotech industries and relevant associations.

 

The guidelines contain specific measures to implement the “Innovative Measures for New Drug Approval” that was announced by the MFDS on Sept.

 

9, including the operation of a dedicated review team for each product and prioritizing GMP-GCP on-site inspections.

 

“Upon the announcement of the rise in the approval fee of new drugs under the Innovative Plan for New Drug Approval, the pharmaceutical industry raised the question of whether the actual approval period will be shortened,” said an MFDS official.

 

”By recruiting reviewers, GMP inspections will be prioritized to be completed within 90 days from the date of the application receipt, and pre-registration of supplementary materials and explanatory meetings will reduce unnecessary delays in the approval process, dramatically shortening the approval period for new drugs from 420 days to 295 days.”

The enactment of the Guideline on Operating Procedures for New Drug Approval and Review was promoted in line with the redetermination of new drug approval fees, which will take effect on January 1, 2025, and includes various changes to differentiate it from the existing approval process, such as the formation of a dedicated team, the establishment of explanatory meetings, and the introduction of a procedure for pre-registration of supplementary materials.

 

From next year, when a new drug approval application is filed, MFDS will conduct an independent preliminary review within 7 days.

 

During the preliminary review period, 80% of the fee will be refundable, and the MFDS will check the submission requirements.

 

If there are any missing materials during this process, the applicant will have 14 days to submit them before an “initiation meeting” is held.

 

Given the overall review timeline, the preliminary review process is crucial as data not submitted by the initiation meeting will be difficult to submit later and the application will be categorized as an application that requires primary supplementary data.

 

A key part of this process is the establishment of a dedicated team for each item before the initiation meeting.

 

The head of the approval division will lead the team, and a representative from the approval division will take charge as each item’s manager, and the team will be composed of representatives from ▲safety, efficacy, ▲quality control, ▲GMP (good manufacturing practice), and ▲GCP (good clinical practice).

 

In addition, an initiation meeting is held within 14 days of receipt to coordinate the entire approval and review process and to provide the applicant with the necessary materials and procedures.

 

The initiation meeting may be held face-to-face, via video, or in parallel, which is expected to increase the efficiency of the new drug review process.

 

According to the proposed Operating Procedures for Approval and Examination of New Drug Products, GMP inspections will be conducted within 90 days from the date of application receipt, and GCP inspections will be conducted within 60 days after the first supplement.

 

By accelerating the inspection schedule compared to the existing procedure, the verification required for the manufacturing and clinical management procedure will be completed at an earlier stage.

 

This is intended to speed up the approval process and ensure adequate quality control.

 

A number of improvements have also been made to the supplement requests.

 

Previously, there were only first and second supplementary notifications, but the reform introduces a first supplementary request briefing session and a second supplementary request briefing session to ensure that the applicant fully understands the supplementary request.

 

In particular, the explanatory meetings provide detailed information on the scope and requirements of the required materials and provide time to answer the applicant’s questions.

 

In particular, for the first round of supplemental data submissions, a pre-registration process and a request for an information session can be made by the applicant.

 

Applicants can pre-register their supplementary data and request the KFDA to hold an explanatory meeting.

 

This allows the adequacy of the supplementary data to be reviewed in advance, reducing additional supplementary work and increasing the efficiency of the approval process.

 

In addition, a final meeting will be held 5 days before the final approval target date to discuss the results of the approval review.

 

“In addition to the effect of shortening the approval period, the revised procedure will improve the transparency of the approval and review process and help pharmaceutical and biotech companies develop new drugs efficiently while protecting the public's health,” said an MFDS official.

 

”We will collect opinions from relevant associations and industries to prepare the final draft and continue to optimize and implement the approval review service for the development of the domestic pharmaceutical industry.”