Drug Approval system under direct control of the MFDS

Controls drug approval system and develops related policies

#Drug Approval System, which was in charge of the National Institute of Food and Drug Safety Evaluation, will be carried out at the headquarters of the MFDS.

 

The 'Convergence Innovation Product Support Group', a temporary organization that has been in charge of licensing affairs since last year, is formally incorporated into a department under the direct control of the Deputy General Manager.

 

The MFDS (Minister Eui-kyung Lee) and the Ministry of the Interior and Safety (Minister Chin Young) reinforce the expertise of medical product approval and review, and to ensure the right to life for the people and strengthen the international competitiveness of companies through rapid productization support.

 

It was announced on the 18th that the system will be reorganized.

 

With the reorganization of the medical product approval/examination system, the approval task that had been carried out by the National Institute of Food and Drug Safety Evaluation will be carried out by the vice-minister of the MFDS, and the review will continue to be carried out by the National Institute of Food and Drug Safety Evaluation.

 

Specifically, for medical product licensing, two new divisions are established and operated, the 'licensing general manager' and the 'high-tech product licensing manager' under the deputy of the headquarters.

 

The NIFDS continues to carry out the evaluation work, and two new divisions are established and operated under the director, the 'pre-counseling department' and the 'expedited examination department'.

 

First of all, among the two divisions of the headquarters, the licensing general manager generalizes the approval of medicines (including herbal medicines) and the improvement of the approval/examination system for all medical products, while the high-tech product licensing manager is responsible for converging medical products and biologics and medical device approval.

 

In addition, the pre-counseling department conducts preliminary consultation on the application for approval of clinical trial plans and product approval of pharmaceuticals, medical devices, and new drugs subject to rapid review, and the expedited examination department designates rapid review of drugs, medical devices and new drugs.

 

Review data on the application.

 

Targets for rapid review are products that contribute innovatively to responding to public health crises or treating diseases such as life-threatening diseases, new infectious diseases, and digital-based medical devices, and categorized into crisis response drugs, innovative new drugs, and innovative medical devices.

 

Since last year, the MFDS has formed a temporary organization called the 'Convergence Innovation Product Support Group' within the NIFDS and has been carrying out the licensing work.

 

Instead, the person in charge of the approval work of the NIFDS-related department was dispatched to the Convergence Innovation Product Support Team.

 

This time, it has become a formal office through reorganization.

 

In addition, in accordance with the recently enacted 'Advanced Renewable Bio Act' and 'Medical Device Act', advanced biopharmaceuticals and innovative medical devices (software) permits and reviews, advanced regenerative medicine high-risk clinical research plans, etc.

 

expand technical experts and introduce and operate a customized screening system.

 

With this reorganization, the government is expected to establish a dedicated review system for high-quality rapid review of new concept medical products in accordance with the 4th industrial revolution and biohealth trends by strengthening policy linkage under comprehensive review of permits and screenings in a rapidly changing era.

 

Through the reorganization of the medical product approval/examination system, the Ministry of the Interior and Safety added rational policy judgment on the basis of scientific basis for approval, and consulted in advance from the R&D stage for the review, while conducting a rapid review for innovative treatments.

 

By shortening the productization period, such as, the opportunity for patient treatment will expand, and it will greatly contribute to rapid response to public health crises.

 

The MFDS has reinforced the policy functions of the headquarters of the license and maintained the evaluation expertise of the NIFDS through the reorganization of the approval/examination system.

 

By shortening it, it has made efforts to strengthen the global market competitiveness of the pharmaceutical industry while putting the life and safety of the people first.

 

The MFDS plans to complete the revision of the 'The MFDS and the Directive Enforcement Regulations of its affiliated organizations' with the goal of the 25th.

 

However, the procedure for passing through the Ministry of Public Administration and Security, which is the main ministry related to the organization, remains.

 

related personnel are expected to proceed in line with the revision.