7 pharmas newly win 'Innovative Pharmaceutical

Companies Certification'

5 pharmaceutical companies received extensions, including Ildong and AZ

Seven pharmaceutical companies, including Dong-A ST, have newly acquired the 'Innovative Pharmaceutical Companies Certification.' Five companies, including Ildong Pharmaceutical, received extensions on their certifications.

 

The Ministry of Health and Welfare (MOHW) announced the result of reviewing the 'Innovative Pharmaceutical Companies Certification' candidates for 2024 through the Pharmaceutical Industry Development and Support Committee meeting held on December 27 (Friday).

 

The result of reviewing the

According to the 'Special Act on Pharmaceutical Industry Development and Support,' the MOHW has been issuing companies that have invested substantially in R&D and those demonstrating superior R&D outcomes for new drugs the 'Innovative Pharmaceutical Companies Certification' since 2012.

 

For instance, the standards for companies based on their pharmaceutical sales are as follows: 7% spending in R&D investment for companies with sales of KRW 100 billion or below, 5% spending in R&D investment for companies with sales of KRW 100 billion or more, and 3% spending in R&D investment in companies that have obtained the U.S·Europe GMP (good manufacturing practice).

 

The 'Innovative Pharmaceutical Companies Certification' for new types is conducted every two years, and for extension cases, it is conducted every three years.

 

When certified, companies can maintain the status for three years.

 

Those certified receive benefits, including added points for participating in government-funded R&D projects, drug price advantages, tax benefits, and regulatory approval support.

 

This round of review for the 'Innovative Pharmaceutical Companies Certification' included both new certification and extension of certification.

 

Twenty-five companies were candidates for new certifications.

 

Seven pharmaceutical companies have passed the certification review, including Dong-A ST, Amgen Korea, Onconic Therapeutics, Curocell, Hanall Biopharma, SK Bioscience, and SK Biopharm.

 

For Dong-A ST, the company won the title again five years after failing the cut due to rebate issues in 2019.

 

List of companies certified as innovative pharmaceutical companies (49 companies as of December 28, 2024).

 

33 general companies, 12 biotech venture companies, and 4 foreign pharmaceutical companies received the title.

For extension reviews, five companies were considered for the review, including Alteozen, ABL Bio, Ildong Pharmaceutical, AstraZeneca Korea, and Janssen Korea, and they all passed.

 

As a result, a total of 49 companies received notifications for obtaining the title of innovative pharmaceutical companies.

 

"Innovative pharmaceutical companies have played a crucial role in advancing the Korean pharmaceutical industry by investing more in R&D than other pharmaceutical companies," Director General Jung Eun-young of the Bureau of Health Industry, MOHW, said.

 

"We will continue to establish support systems and improve policies to encourage these companies to continue to expand their R&D investments, enhance innovativeness, and create values."