Four Companies Including CrystalGenomics Fail to Qualify as Innovative Pharmaceutical Firms

Four pharmaceutical companies, including Chong Kun Dang, CrystalGenomics, Korea United Pharm, and Genewon Science, were excluded from the list of innovative pharmaceutical companies.

The Ministry of Health and Welfare announced on the 20th the results of the 2024 certification extension for innovative pharmaceutical companies after deliberation by the Pharmaceutical Industry Promotion and Support Committee.

Innovative pharmaceutical companies are certified based on the "Special Act on the Promotion and Support of the Pharmaceutical Industry," which has evaluated and certified companies with a certain level of research and development (R&D) investment ratio and excellent new drug R&D performance since 2012. The R&D investment ratio criteria are based on total sales: companies with pharmaceutical sales under 100 billion KRW must have at least 7%, those with sales over 100 billion KRW must have at least 5%, and companies that have obtained US or European Good Manufacturing Practice (GMP) certification must have at least 3%.

This certification extension review was conducted for companies whose certification expires this month. As a result, 24 companies were approved for certification extension (re-certification), while 4 companies were excluded from the innovative pharmaceutical companies list. ▲Green Cross ▲Daewoong Pharmaceutical ▲Daewon Pharmaceutical ▲Daehwa Pharmaceutical ▲Boryung ▲Bukwang Pharmaceutical ▲Samyang Holdings ▲Celltrion ▲Shinpoong Pharmaceutical ▲ST Pharm ▲HK Inno.N ▲Yuhan Corporation ▲Isu Abxis ▲Taejoon Pharmaceutical ▲Handok ▲Hallym Pharmaceutical ▲Hanmi Pharmaceutical ▲Hyundai Pharm ▲LG Chem ▲SK Chemicals ▲Medytox ▲BC World Pharm ▲Helixmith ▲Korea Otsuka succeeded in re-certification, but ▲Chong Kun Dang ▲CrystalGenomics ▲Korea United Pharm ▲Genewon Science were disqualified.

Thus, the total number of innovative pharmaceutical companies has decreased to 42. Innovative pharmaceutical companies receive new certification every two years and maintain their certification status for three years upon re-certification. To maintain the status of an innovative pharmaceutical company, companies must meet the R&D investment ratio criteria relative to sales and have no disqualifying reasons. Disqualifications include administrative penalties of two or more fines due to rebates, or if directors or auditors have been sentenced to fines or higher for embezzlement, breach of trust, stock manipulation, assault, sexual crimes, etc.

Jung Eun-young, Director of the Health Industry Policy Bureau at the Ministry of Health and Welfare, stated, “Since the introduction of the innovative pharmaceutical company system, it has played an important role in the development of the domestic pharmaceutical industry. We will gather field and expert opinions to establish reasonable system improvement measures to meet global standards and create a foundation for innovation and competitiveness in the pharmaceutical industry.”