Drug e-labeling and abolition of PMS reexaminations...

MFDS plans to undertake regulatory reform…

MFDS selects 20 tasks to innovate regulations through internal discussions

Yoo Kyung Oh, Minister of Food and Drug Safety “will not unilaterally announce regulations... will listen to industry opinions”

The Ministry of Food and Drug Safety announced that it will refrain from making a unilateral announcement of regulations, and Suk-Yeol Yoon’s government announced that it would reform regulations by listening to the opinions of the industry.

 

As part of such efforts, the MFDS had conducted 7 internal discussions since Yoon’s inauguration to set tasks for regulatory innovation and conducted a national public debate at the Korea Chamber of Commerce and Industry from 10:00 a.m.

 

today (21st).

 

(From the left) Seok Yeon Kang, Director-General of the Pharmaceutical Safety Bureau; Sang Bong Kim, Director-General of the Biopharmaceuticals and Herbal Medicine Bureau; Nam Hee Lee, Director-General of the Medical Device Safety Bureu; Hun Woo Hong, Deputy Director General for Narcotics Safety Planning

Through the public debate, the MFDS was able to prepare key tasks to review for regulatory innovation, including ▲the introduction of a classification system for temporary items such as digital healthcare devices, ▲support for rapid development of biopharmaceuticals developed using innovative technology (microbiome, exosome, etc.) ▲expanding designation of innovative medical devices ▲promote allowance of the manufacture and import of cannabis containing pharmaceuticals ▲preparing a classification and safety management system that aligns with the characteristics of combination products ▲exemption from receiving MFDS approval for clinical trial protocols for medical devices with a low understanding ▲allowing the performance of clinical trials on diagnostic software at sites other than clinical trial institutions, etc.

 

Also, the MFDS plans to review 20 tasks including: ▲expanding subjects for prior review to rapidly commercialize medical devices, ▲phased introduction of e-labels for pharmaceuticals ▲ private-led conversion of natural/organic cosmetic certification system ▲allowing holding concurrent positions as a manufacturing manager for low-strength vitamin preparations (quasi-drugs) ▲Expanding the use of overseas investigational drugs for therapeutic purposes ▲Improving post-marketing surveillance systems for biopharmaceuticals ▲transferring the sample collection procedure required for national lot release approval to the private sector ▲Introduction of a differential management system when changing labels of a drug ▲Improving indications for quality testing of biologics ▲Simplifying application for performance testing of in-vitro diagnostic devices ▲Abolishing reporting obligations on use of cosmetic ingredients ▲Abolishing reexamination of of post-marketing safety management system and , integrating it into the risk management plan ▲ abolishing the transfer approval system to return medical narcotics.

 

More specifically, in the case of changing the labels of a drug, the company had to change the insert paper in its printed form within the grace period (1-3 months), however, through the phased introduction of the e-label, the ministry plans to provide safety information in real-time with the e-label when labeling changes occur.

 

Also, to allow for the use of real-world data (RWD) in the post-marketing pharmacovigilance of vaccines for infectious pandemic diseases, the MFDS will improve the post-marketing pharmacovigilance system for biopharmaceuticals, as in the US and Europe.

 

Also, among the post-marketing safety management system that has been dualized into the reexamination and risk management plan system, the MFDS will work to abolish the reexamination system and integrate it into the risk management plan system.

 

In the case of the abolition of the transfer approval system, as people had complained of the work delay on site due to the transfer approval procedures of the medical institution, pharmacy, etc.

 

after the transferee receives approval from the competent licensing authority and returns the pharmaceutical to the original owner.

 

Therefore, the system will be improved so that narcotics and psychotropic drugs may be returned to the original owner without approval from the competent licensing authority.

 

At the event, Yoo Kyung Oh, Minister of Food and Drug Safety, said “the subject of regulations is important for the industry to emerge into the global market while ensuring safety.

 

Regulatory innovation should not be a unilateral process where the government decides to lift certain regulatory items and announces it.”

Yoo Kyung Oh, Minister of Food and Drug Safety announced that the ministry will l refrain from making a unilateral announcement of regulations at the ‘Public Debate on Regulatory Innovation for the Medical-Pharmaceutical Industry”

Minister Oh added, “The MFDS is a regulatory institution that protects public safety.

 

I have contemplated much on wetting the right regulatory target for the past 50 days since my appointment.

 

Regulations play an important role in protecting safety but they may act as a barrier to the industry, so we held 7 internal discussion sessions on regulatory innovation.” Minister Oh said, “The regulatory barriers in the pharmaceutical sector are high and we still have a long way to go.

 

The MFDS wishes to support the pharmaceutical industry’s prompt entry into the global market.

 

Yoon’s administration also aims to innovate the administrative process for food and drugs to meet the international standards, therefore we will humbly listen to the voices of the people rather than unilaterally act on it.”

On the 21st, the MFDS held a Public Debate on Regulatory Innovation for the Medical-Pharmaceutical Industry” at the at the Korea Chamber of Commerce and Industry.

The MFDS plans to publicly announce its tasks for regulatory innovation that can be felt by the public and industry, including the regulatory innovation review tasks that were disclosed this time.

 

Also, the MFDS announced it will continue to maintain a regulatory innovation system to aid public convenience and industry development, by operating public-private consultative bodies in each field and operating a regulatory innovation promotion team under the MFDS.