'Innovative Pharmaceutical Company' Certification System Completely Overhauled After 14 Years... Raising R&D Investment Standards

The core of the reform is to strengthen new drug development capabilities by raising R&D investment standards, while simultaneously enhancing the objectivity and transparency of the system by simplifying and quantifying certification evaluation indicators. The Ministry of Health and Welfare announced on the 30th that it has promulgated and issued amendments to the Enforcement Decree and Enforcement Rules of the 'Special Act on the Promotion and Support of the Pharmaceutical Industry' and the 'Regulations on Certification of Innovative Pharmaceutical Companies, etc. ' Under this reform, the ratio of pharmaceutical R&D investment to pharmaceutical sales among the certification standards for innovative pharmaceutical companies will increase by 2 percentage points compared to the existing standards.
For companies with average sales of less than 100 billion won over the previous three years, the R&D ratio standard will be raised from the existing 7% to 9%, and the minimum R&D investment amount will be increased from 5 billion won to 7 billion won. The threshold for companies with sales exceeding 100 billion won will increase from 5% to 7%, while that for companies certified as GMP compliant by the U. S.
or the European Union will increase from 3% to 5%. However, considering the burden on companies, the application of these revised standards will be deferred for three years following the effective date.
The certification review process will also change. The number of detailed evaluation indicators will be reduced from 25 to 17, and the total score will be adjusted from 120 points to 100 points.
Four items, including R&D investment, the number of clinical trials, and export volume, will be converted into quantitative indicators to enhance the objectivity of the evaluation. A new item evaluating the contribution to the stabilization of the pharmaceutical supply chain will also be introduced.
The disqualification criteria for certification related to rebates will also be rationalized. Previously, reviews were based on administrative dispositions within the last five years, but going forward, judgments will be based on the "date the violation ended" rather than the "date of the administrative disposition.
" Accordingly, if the violation ended five years ago, it will be excluded from the review process. In cases where an administrative appeal or lawsuit is filed regarding an administrative disposition, certification may be revoked within one year from the date of the dismissal decision or judgment.
A separate certification type for foreign pharmaceutical companies will also be established. Previously, domestic and foreign companies were subject to the same evaluation system, but going forward, they will be evaluated separately as 'General Innovative Pharmaceutical Companies' and 'Foreign Innovative Pharmaceutical Companies.
' Points for attracting domestic R&D and production facilities, foreign capital, joint research, and open innovation will be increased for foreign companies. Conversely, points for the development of non-clinical and clinical candidate substances, patent technology transfer, and overseas expansion will be lowered, taking into account the characteristic that the headquarters holds technology and patents.
Transparency in the certification process will also be strengthened. Detailed evaluation indicators and the minimum passing score of 65 points will be specified in the official notice, and companies that fail to obtain certification will be notified of the specific reasons for non-certification.
The Ministry of Health and Welfare plans to accept applications for new Innovative Pharmaceutical Company certification for one month, from August 18 to September 18. The plan is to finalize new certifications within the year following deliberations by the Certification Review Committee and the Pharmaceutical Industry Promotion and Support Committee.
Sung Chang-hyun, Director General of the Health Industry Policy Bureau at the Ministry of Health and Welfare, stated, "This overhaul of the innovative pharmaceutical company certification system, the first in 14 years, is a measure to provide more robust support to innovative companies that actively invest in research and development. " He added, "We will spare no support to ensure that domestic pharmaceutical and bio companies can dedicate themselves to new drug development research and grow into globally competitive enterprises.
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The core of the reform is to strengthen new drug development capabilities by raising R&D investment standards, while simultaneously enhancing the objectivity and transparency of the system by simplifying and quantifying certification evaluation indicators. The Ministry of Health and Welfare announced on the 30th that it has promulgated and issued amendments to the Enforcement Decree and Enforcement Rules of the 'Special Act on the Promotion and Support of the Pharmaceutical Industry' and the 'Regulations on Certification of Innovative Pharmaceutical Companies, etc. ' Under this reform, the ratio of pharmaceutical R&D investment to pharmaceutical sales among the certification standards for innovative pharmaceutical companies will increase by 2 percentage points compared to the existing standards.
[email protected] Kang Jung-mo Reporter