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Drug regulator to enhance clinical trial management by 2023
  • By Lee Hye-seon
  • Published 2019.08.08 14:55
  • Updated 2019.08.08 14:55
  • comments 0

The Ministry of Food and Drug Safety on Thursday announced a “Comprehensive Five-year Plan for the Advancement of Clinical Trials,” aimed at upgrading local clinical trials by 2023.

The comprehensive plan, composed of three key strategies and 21 detailed tasks, is to broaden treatment opportunities for rare and intractable diseases, protect the rights of clinical trial participants, and improve the capability to develop new drugs.

The three strategies are establishing a clinical trial safety management system, strengthening international competitiveness in clinical trials, and expanding treatment opportunities and the communication system for patients.

Strengthening safety control in clinical trials

To establish a better safety management system for clinical trials, the ministry plans to mandate drugmakers to report regularly the safety information of all investigational drugs. Currently, companies must report safety information if a serious and unpredictable drug adverse reaction occurs.

The government will also regularly check on hospitals with high-risk clinical trials where vulnerable subjects, including toddlers, participate, those with many side effects, and those testing the first developed drug. The ministry will also enhance special inspections item by item and disclose inspection results.

The ministry plans to establish a new “Central Clinical Trial Review Committee,” designated by the government, to assess contract-based clinical trials and offer consultations for the operation of a separate review committee within a medical institution. The ministry said it would prepare related data this year to operate the committee from 2021.

From 2021, the government aims to set up a help center for clinical trial participants to give them customized information, provide counseling for an informed consent form for clinical trials and related educational/promotional program.

Differentiating approval system to shorten clinical study approval

The food and drug safety ministry said it would gradually introduce a differential clinical trial approval system in 2020 to grant a test based on essential data, on the condition that the test has secured safety. Essential data includes the information of the experimental drug, the institution participating in the trial, and the approval of the Clinical Trial Review Committee.

The new system will apply to multinational phase-3 trials that have already obtained the nod in major countries. The new system will shorten the period of approval, help the drugmaker enter the trial early, and expand treatment opportunities, the government said.

Even if the government introduces a differential approval system, the ministry will have drug companies submit results of the Clinical Trial Review Committee’s assessment and regular monitoring procedures, to protect patients.

If a company has secured credibility through a fact-finding study, the government will recognize the data of non-clinical trials conducted in non-OECD members, the ministry said. The U.S. and Europe have the same system.

From this year, companies will not have to obtain the ministry’s approval for a change in the plan for a clinical study but to report the plan instead.

To prompt drug companies to predict clinical trial results better, the government will run a “Preliminary Review System.” When a person or a company applies for a clinical trial application, the food and drug safety ministry will go over the data within five days, reply it back with the feedback to the assessment department within 15 days, and make the final feedback within 20 days.

Hiring more reviewers, establishing Clinical Trial Review Division

For rare and intractable patients who have no treatment in Korea, the government will simplify the “urgent” approval process. Currently, when a patient wants to use an investigational drug for treatment, the ministry is to make an approval decision within seven days. However, if it is for an urgent patient, the government will approve it on the day of receiving the application.

The ministry said it would hire seven more clinical trial reviewers for new drug development and frequently developing diseases. It also plans to establish the “Clinical Trial Review Division” in 2020 to be in charge of approval for clinical trial plans and their changes.

In 2022, the ministry will set up “Clinical Trial Management Team” by integrating clinical trial policy division, clinical trial management division, clinical trial information management division, non-clinical trial policy division, and clinical trial assessment division.


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