MFDS' pharma policy keyword, 'shorten time'

Higher fee for new drug approval…two pre-registration consultation sessions have been held

Will implement a 'Path Program' supporting the process from development to commercialization

According to the business plan announced by the Ministry of Food and Drug Safety (MFDS) this year, support policy to facilitate quick market entry for new drugs and innovative products stands out.

 

The 'Ministry of Food and Drug Safety's Major Policy Implementation Plan for 2025' announced on January 21 by the MFDS contains its aim to shorten the duration of development to commercialization using various systems.

 

First, the MFDS will newly establish a dedicated review team this year to provide expert consultation services at each approval stage.

 

Improvement of panel·process for approval·review.

The new drug approval fee increased to KRW 410 million.

 

The MFDS will prioritize document review and GMP site monitoring and plan to shorten the approval duration from 420 to 295 days.

 

The MFDS will implement a priority review policy to expand the number of interview consultations (3→10) and prioritize the review of a document that requires supplementation as soon as it is completed.

 

Additionally, the MFDS will improve the expetise of the review panel and regulatory capacity by continuosly expanding the percentage of experts within the review panel, including doctors and pharmacists, developing educational programs for the latest technologies, and conducting training programs customized to the panel's work experience (basic·core·intensive).

 

Notably, companies can apply for a single pre-registration consultation session before applying for a new drug marketing authorization.

 

It has been reported that two consultation sessions have been held to date.

 

Kim Sang Bong, Director of the Pharmaceutical Safety Bureau, stated during the briefing held on January 20, "We have held two pre-registration consultation sessions until today." Kim added, "Yet, we do not have a record of the new drug application that was submitted." "The MFDS announced a documented plan for a procedure that is equivalent to the level of new drug assessment in advanced pharmaceuticals countries such as the U.S.

 

and Europe," Kim said.

 

"To efficiently run the annouced process, we will assign review panels and expand expert personnel with a strong background." Starting in April, the MFDS will implement a regulatory suitability review system where innovative product R&D research as part of government R&D projects will be selected and provide regulatory requirements, process, and commercialization strategy.

 

The

The MFDS will run a 'Path Program,' providing approval guidelines to support new technology-based product development, including gene diagnosis and antibody-drug conjugate technologies, and facilitating prior-registration consultation for each stage, such as clinical trials·approval, and expedited review.

 

"The MFDS will implement a 'Path Program' linking the With-U prior-registration consultation, clinical trial review, and GIFT expedited review," Kim said.

 

"Previously, we received a review that each program runs without smooth transition, so we designed a program to overlook the transition." The 'Path Program' is projected to shorten the time for innovative product development to commercialization.

 

Kim stated, "We cannot guarantee that the time will greatly reduce, but the program has the advantage in terms of predictability and transparency."

Kim Sang Bong, Director of the Pharmaceutical Safety Bureau

The MFDS also plans to establish a stable pharmaceutical supply network this year.

 

Starting in April, to prepare for the pharmaceutical supply shortage, the MFDS will set a preliminary report date of 180 days before the supply discontinuation of production and imports by pharmaceutical production·import companies and mandate reporting of supply shortage.

 

"The government is in the process of establishing a safety network for efficient transaction between various policies, including national essential drugs, private-public committee for supply shortage, and consignment production·production by orders," Kim said.

 

"Reporting of supply shortage is one of the advanced measures." "The pharmaceutical industry may take these updates as another regulatory measure, but the intent of these policies is to predict supply shortage in advance and to secure time for each policy measure to run smoothly," Kim said.

 

"The MFDS aims to prevent supply shortage in advance and allow companies to receive administrative support."