Health ministry overhauls drug firm certification to boost R&D investment

The health ministry on Thursday announced a comprehensive overhaul of the innovative pharmaceutical company certification system to support firms that actively invest in research and development. The revision marks the first major update to the program in 14 years, introducing stricter spending requirements alongside a simplified evaluation framework.

Sung Chang-hyun, director general of the ministry's health industry policy bureau, said the changes are designed to help domestic pharmaceutical and bio companies focus on new drug development and grow into globally competitive entities. "We will not spare any support so that these companies can concentrate on research and develop world-class competitiveness," he said.

Under the new rules, the threshold for research and development spending relative to pharmaceutical sales will rise by two percentage points across all company types, though enforcement of this higher standard will be deferred for three years. For manufacturers already holding good manufacturing practice certifications from the United States or European Union, the required R&D ratio will jump from 3 percent to 5 percent of sales. These revisions were formalized under amendments to the Enforcement Rules of the Special Act on the Promotion and Support of the Pharmaceutical Industry, which were promulgated and took effect on July 30, 2026.

The ministry streamlined the assessment process by lowering the total possible score for certification exams from 120 to 100 points and cutting the number of evaluation items from 25 to 17. Four key categories, including R&D investment volume, number of clinical trials and export scale, were converted into quantitative indicators.

A new certification category specifically for foreign-affiliated pharmaceutical companies was established to attract overseas capital and foster open innovation. Companies in this tier will receive higher scores for establishing domestic research and production facilities, securing foreign investment, and engaging in joint research projects. A new evaluation item was also introduced to assess corporate social responsibility based on contributions to stabilizing the pharmaceutical supply chain.

Transparency measures were strengthened as the ministry set the minimum passing score at 65 points in official notices. Companies that fail to secure certification will now receive formal notifications explicitly stating the reasons for their rejection.

Applications for the revised certification program will be accepted from Aug. 18 to Sept. 18, with the ministry planning to finalize new certifications before the end of the year following reviews by the Certification Review Committee and the Pharmaceutical Industry Promotion and Support Committee.