New drug approval fee to rise next year

Guidelines will soon be set

Aims for approval within 295 days of receipt of a new drug application

The finalized guideline that reflects industry opinion will be released

The Ministry of Food and Drug Safety has begun finalizing plans to raise the new drug approval fee KRW 410 million from January 1 next year.

 

The MFDS recently collected opinions on the “Operating Procedures for Approval and Examination of New Drug Products (Guideline for public officials)” from October 18 to November 15, and released the final revised guidelines that reflect consultative body discussions and industry opinion.

 

The guideline, which is set to be enacted on the 11th, contains 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.

 

The new drug approval fee will be revised for new drugs (including advanced biopharmaceuticals) and orphan drugs that have been approved as orphan drugs and then converted to new drugs (change of approval).

 

To expedite the approval of new drugs, MFDS has ▲shortened the approval period (295 days), ▲established a dedicated review team for each product, ▲prioritized manufacturing and quality control (GMP) and clinical trial (GCP) surveys, and ▲newly established a procedure for pre-registering supplemental submission data.

 

The timing of each step, including the target approval date for new drugs under this procedure, is based on calendar days (including holidays and Saturdays) unless otherwise specified.  Meeting the target approval date requires the cooperation of the pharmaceutical manufacturer to be met, with the caveat that the target date for receipt of the first supplement is D-60 and that there should be no delay in the on-site inspection schedule due to the applicant's circumstances.

 

In addition, in the case of an application for conversion to a new drug after approval as an orphan drug (change of approval), a fee must be paid and a review conducted for the review of the areas requiring additional data review.

 

However, no fee is required if the data submission has been completed and reviewed at the time of orphan drug approval.

 

In addition, if the applicant reapplies for the same item within a period of 2 years from the date of rejection (withdrawal), only the supplemented data (other than the data that was reviewed before the rejection (withdrawal)) can be reviewed and processed.  According to the procedure for the approval and examination of new drug applications, applicants can request a preliminary consultation before application.

 

This can only be done a single time for each new drug that is scheduled to be filed within 3 months.

 

The fee must be paid on the date of the application submission, and the fee cannot be canceled after submission.

 

In the case of a complaint, the applicant may submit a possible on-site inspection period (at least three periods) for its local manufacturing site to be inspected.

 

The preliminary review will be conducted within 7 days of application receipt, and the dedicated team for each item organized within 10 days of receipt.

 

The initiation meeting for the marketing authorization review will be held within 14 days of receipt, either in person (in Osong), via video, or a combination of in-person and video.

 

The outcome of the meeting will be notified to the applicant within 10 days from the date of the initiation meeting.  The outcome of the initiation meeting will additionally include an estimated timeline for the agreed-upon milestones (GMP inspection schedule, expected date of first supplemental data notification, recommended date for completion of supplemental data submission for expedited processing (D-60), and target approval date).

 

GMP inspections are conducted within 90 days of the application receipt and GCP inspections are conducted within 60 days of the first supplement.

 

Various improvements have also been made to the supplement requests.

 

Previously, the authorities only made the 1st and 2nd supplement notifications, but the revised proposal introduces a 1st supplement request briefing session and a 2nd supplement request briefing session to ensure that the complainant fully understands the supplement request.

 

After the supplementation, the review process will be completed with a meeting of experts such as the Central Pharmaceutical Affairs Council, a final meeting (5 days before the target approval date), and final complaint processing by the approval department.