The ‘2023 ICPI Week (International Pharmaceutical and Cosmetics Week)’ exhibition, where you can take a look at the entire supply chain from drug and cosmetics development to manufacturing and logistics distribution, opened on the 18th at KINTEX Exhibition Hall 1 in Goyang. This exhibition is held under the supervision of the exhibition organizers, Contest Exhibition and KY Expo, and runs until the 21st (Fri).
The characteristic of this exhibition is that it is possible to check the ecosystem that constitutes the supply chain related to the development and manufacturing of the market in one place. Accordingly, this exhibition introduces products and technologies for ▲design and development of medicine, bio, and cosmetics ▲laboratory science ▲production process and packaging ▲cold chain and logistics technology. .
On the third day of the exhibition, on the 20th (Thursday), the first half of 1 drug screening briefing session was held in the on-site seminar room G of KINTEX Exhibition Hall 2023. At this briefing, which was held with the seats filled with pharmaceutical industry officials, Na-Young Yun, Director of the Rapid Review Division of the Food and Drug Safety Evaluation Institute, introduced the Global Innovative Product Rapid Review Support System (GIFT).
The Rapid Review Division was newly established in August 19, when Corona 2020 was in full swing, and its mission was to launch a joint review of the Corona 8 vaccine treatment and commercialize it. In this regard, he was in charge of the rapid review of AstraZeneca’s vaccine item approval, and completed the item approval review of the domestically developed Corona 19 vaccine ‘SkyCoby One Multi Inj’ after going through several vaccines. Since then, in September 19, the Rapid Screening Division has established and is operating the ‘GIFT’ program.
GIFT, which was especially emphasized on this day, targets treatments such as life-threatening diseases and new drugs developed by innovative pharmaceutical companies designated and established by the Minister of Health and Welfare. The system refers to the Ministry of Food and Drug Safety’s rapid screening activation support system for global innovative products in order to quickly launch innovative medicines on the market and quickly supply them to patients. It is being operated as one of the top 100 food and drug regulatory improvement tasks to promote innovation in the abolition of food and drug industry regulations by the Ministry of Food and Drug Safety, and aims to strengthen support from the early stage of development (clinical) so that global innovative medical products can be quickly commercialized. .
Regarding this, Na-Young Yun, director general, said, “GIFT stands for Global Innovative products on Fast Track, and provides opportunities for quick treatment like a gift through rapid screening of innovative and gifted medicines that can open up new treatment areas. ‘,” he said. “The requirements for data to satisfy the approval regulations are the same as the existing general review, but some data that do not affect safety can be submitted after approval, and we preemptively set the global review standards. We are working to apply them simultaneously. In addition, we are providing close support, such as strengthening regulatory consulting through close communication between reviewers and developers, such as item briefings and security briefings,” he emphasized.
He also emphasized that casebooks and reports were prepared to enhance understanding of expedited screening and provide information on how it operates in other countries. “I prepared this in the hope that our products will be able to ride the speedy track even when they go abroad,” said Yoon Na-yeong, director general. In particular, it was introduced that it presented actual overseas review cases such as smallpox treatment and anthrax treatment that can be applied to Mpox, and contained detailed information about what data was submitted and what issues were raised.
Yoon Na-young, director general, also announced plans to promote GIFT in 2023. Superintendent Yoon said, “First of all, we want to form a one-on-one consultative body and provide close support according to the characteristics of each item, like the so-called ‘one-time instructor’. We want to shorten the period from designation to approval for the purpose of mutual communication at each stage of development for quick commercialization,” he said. If GIFT-designated items are released in English, information will be available abroad. We will push for this system to be recognized as a very trustworthy brand,” she said.
Lastly, it was also explained about the rapid screening designation for orphan anticancer drugs for which there is no existing treatment and the simultaneous designation process for orphan drugs. “Previously, we had a sequential process in which we were able to apply for expedited review after at least 20 days, such as 30 days for orphan drug designation and 50 days for rapid review target designation,” said Yoon. It is a system that shortens the overall review period by shortening the designation stage.”
Meanwhile, the ‘2023 ICPI Week (International Pharmaceutical and Cosmetic Week)’ exhibition, which allows you to look at the entire supply chain from pharmaceutical and cosmetic development to manufacturing and distribution in one place, is held at ▲International Pharmaceutical and Bio Industry Exhibition (KOREA PHARM) & BIO) ▲International Cosmetic Raw Materials and Technology Exhibition (CI KOREA) ▲International Research, Experiment and Analysis Equipment Exhibition (KOREA LAB) ▲International Chemical Equipment Industry Exhibition (KOREA CHEM) ▲International Pharmaceutical, Bio and Cosmetic Technology Exhibition (COPHEX) ▲International Logistics Industry Daejeon (KOREA MAT) ▲It consists of the International Cold Chain Industry Exhibition (KOREA COLD CHAIN).
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