The Ministry of Health and Welfare will overhaul Korea’s innovative pharmaceutical company certification system from August, introducing an absolute evaluation model expected to expand the number of certified firms.
Under the revised system, companies scoring 65 points or higher will qualify for certification, with no limit on the number of firms selected.
Applications will open in August, with the final list of certified companies to be announced in December.
Lim Kang-seop, director of the Pharmaceutical and Bio Industry Division at the Ministry of Health and Welfare, speaks during a recent meeting with health industry journalists about the proposed reforms. (KBR photo)
Lim Kang-seop, director of the Pharmaceutical and Bio Industry Division at the ministry, outlined the plan during a recent meeting with health industry journalists.
The ministry is accepting public comments until May 6 on a proposed amendment to the regulations. The revision excludes violations older than five years from evaluation penalties and introduces separate tracks for domestic and foreign-invested pharmaceutical companies.
Following the consultation, the proposal will undergo regulatory screening and legal review, with implementation expected in early to mid-August. Applications are likely to run through September, Lim said.
After submission, the Korea Health Industry Development Institute (KHIDI) will conduct an initial document screening to assess eligibility, including R&D investment ratios and disqualifying factors such as recent rebate violations or unethical conduct.
“If a company is found to have any disqualifying issues, it will be eliminated immediately,” Lim said.
Companies that pass screening will undergo further document and interview evaluations, followed by review by the Pharmaceutical Industry Promotion and Support Committee.
More than 100 companies are expected to apply under the new system, reflecting the government’s aim to broaden certification.
The evaluation framework has been streamlined, with the total score reduced to 100 from 120 points and the number of criteria cut to 17 from 25.
Key metrics include R&D investment, number of clinical trials and export performance, which have been converted into quantitative indicators to improve objectivity. A new category for corporate social responsibility, including contributions to supply chain stability, has also been added.
Some criteria, such as partnerships, clinical development and corporate transparency, have been given greater weight, while those related to research personnel, facilities and R&D strategy have been reduced.
“Both quantitative and qualitative indicators will be included,” Lim said. “Quantitative metrics are being calibrated on a five-point scale, while qualitative indicators will be assessed under separate evaluation guidelines.”
The ministry plans to provide detailed guidance through briefing sessions once the system is finalized.
On compliance, Lim said companies’ efforts to strengthen internal controls after violations will be reflected in qualitative assessments.
The ministry is also considering a new category of “quasi-innovative pharmaceutical companies” to support smaller firms with strong R&D capacity, though details have yet to be finalized.
Kwak Sung-sun
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