한국바이오의약품협회

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Vol. 92 (August 19, 2019)

Data 2019-09-02 11:36:29
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A Biweekly Updated Biopharmaceutical News Service

2018 Drug Approval Report

■ The MFDS(Ministry of Food and Drug Safety) published '2018 Drug Approval Report' to support the systematization and efficiency of establishment/enforcement of related regulations and drug approval/notification, and product development by sharing the information on approval/notification of all drugs in line with the 2017 Drug Approval Report.

Main Contents

General information on drug approval/notification (Overall) in 2018
Information on approval of drugs (chemical)
Information on approval of biopharmaceuticals
Information on approval of herbal medicine products and so on

Download the 2018 Drug Approval Reports in ENG

Prepare the clinical trial development road-map to increase opportunities for patient treatment and to support new drug development!

MFDS sets up the patient based

“5-year comprehensive plans for clinical trial development”

■ The MFDS(Ministry of Food and Drug Safety) sets up the 3 initiatives to become the patient-centered new drug developing powerhouse by reinforcing global competitiveness clinical trials

Have established a 5-year comprehensive plan composed of 3 initiatives and 21 detailed initiatives to increase treatment opportunities for the rare incurable diseases as well as protect the rights of the clinical trial participants and to enhance the new drug development capabilities.

(Safety) Establish the safety control system in clinical tests
(Competitiveness) Reinforce international competitiveness in clinical tests
(Communications) Increase treatment opportunities for patients and set up a communication system

Key Details of the Road-map

The following is a summary of the MFDS press release and the full comprehensive plan made by KoBIA. Please check the MFDS and KoBIA website for the full details and comprehensive timeline

(Safety) The safety control system in clinical trials

Make it mandatory to report all the safety information of drugs used for clinical trials on a regular basis
Reform post control system: For high-risk clinical trials, reinforce the monitoring of clinical test performing institutes and strengthen special monitoring by item
※ High-risk clinical trials: In the event, the vulnerable (infant etc.) is included in the clinical trial participants, multiple incidents of negative effects, the very first drug development in and outside Korea, etc.
Promote the establishment of Central IRB (Institutional Review Board) and Supporter Center
※ Central IRB: A consigned review of clinical tests, advising on the operation of separate review committees within medical institutions, etc.
※ Supporter Center: Provide custom clinical information for patients managed by the government, counseling support and related training and PR
Set up plans for a hub (Central Lab) for sample analysis of clinical tests: Attract the Asian Regional Sample Analysis Center

(Competitiveness)
Beef-up the international competitiveness of clinical trials

Adopt the differentiated approval system in phases: Approve the safety guaranteed clinical trials by only entering the required information including study drug information etc. to allow early admission of the clinical trials
※ Priorities for the differentiated approval system: Multinational phase 3 clinical tests approve by major nations
Recognize the non-OECD countries’ non-clinical test data if reliability is gained after fact surveys over the implementation and control level of the non-clinical test control standards
Exclude the quality and safety part, change the “change approval required” matters among clinical trial plans to “report” matters
Enforce the preliminary review system: Check the completeness of the submitted documents within 5 business days
Operate the clinical test review TFT (task force team): Newly set up in Clinical Trial Review division
Form the basis for safety control after-sales leveraging RWD (Real World Data) and RWE (Real World Evidence) (Scheduled to publish the casebook for application of overseas approvals in Oct. 2019)
Develop and distribute government level training contents for the expertise of those working in clinical tests (2019~)
Secure internal reviewer pool by actualizing the review fee (2019~)

(Communication) Increase treatment opportunities

for patients and set up a communications system

Establish and operate the information disclosure system: Provide the patients with information in advance, gain objectiveness and transparency in the enforcement process
From a humanitarian perspective, a local clinical test is not performed against life-threatening rare diseases without alternative treatment, however, allow priority application of the drugs which are already in use overseas through clinical trials
Set up “emergency” approval process for rare incurable disease patients: Approve the application of clinical test drug for treatment purpose on the same day as applied for the emergency patients
Tighten the collaboration with the related agencies including KONECT (Korea National Enterprise for Clinical Trials), diversify communication channels, and widen the international cooperation projects

5-year Comprehensive Plans for Clinical Trial Development