"To secure market leadership opportunities, a fast-track approval system is essential for domestic pharmaceutical and biotech companies," said Park Hyun-jung, head of the Bio-Pharmaceutical Approval Division at the Ministry of Food and Drug Safety (MFDS). She made these remarks on May 14 during the 16th Global Healthcare Forum (2026 GHF) held at the Korea Press Center in Seoul, organized by Aju Economic Daily.
Park emphasized the necessity of establishing a fast-track approval system to facilitate the rapid growth of domestic pharmaceutical and biotech companies. The global pharmaceutical market is projected to expand to approximately $2.66 trillion by 2030.
She noted that the export volume of domestic pharmaceuticals is also increasing rapidly, particularly in high-value sectors such as biopharmaceuticals and toxins. The export value rose from $7.04 billion in 2021 to a record $10.41 billion last year.
The MFDS has been implementing the first phase of its "Drug Approval Review Innovation" initiative since January 2025. This initiative aims to enhance the speed and transparency of drug approvals, viewing expedited approvals as a foundation for global competitiveness in the pharmaceutical industry.
Park pointed out that with many global blockbuster biopharmaceutical patents set to expire in the near future, new opportunities are emerging for the domestic biosimilar industry. She stressed the importance of increasing the speed and predictability of the approval process to secure market leadership.
A key focus is on reducing the approval review period. The average time for new drug approvals has been cut from over 400 days to 295 days.
"We operate dedicated review teams for each product and provide specialized consultations at each approval stage, including pre-review of supplementary submission materials," Park explained. "We have also prioritized the evaluation of Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP) to reduce the burden on companies and enhance review efficiency."
Following the first phase, the MFDS plans to implement a second phase of innovation. This will be discussed at the second core regulatory rationalization strategy meeting chaired by the President, focusing on fostering the biohealth industry and transitioning to a consumer-centered approval review system while significantly shortening the drug approval review period.
The agency is gathering industry feedback on new drugs and biosimilars and plans to significantly increase the number of specialized review personnel. In April, the MFDS hired new staff for drug approval reviews and is pursuing additional recruitment.
Park also introduced plans to simplify Phase III clinical trials for biosimilars. "With advancements in quality analysis technology and accumulated regulatory experience since the introduction of biosimilars, it has been confirmed that equivalence can be demonstrated for certain products without Phase III clinical trials," she said.
She added, "We plan to demonstrate equivalence between new biopharmaceuticals and biosimilars primarily through quality comparisons and Phase I clinical trials, conducting Phase III trials only when sufficient evidence is lacking. We will also allow for pre-review requests of equivalence demonstration plans by the MFDS."
Park concluded, "Through these regulatory improvements, patients will be able to access new drugs and biosimilars more quickly, and the industry will reduce its burden through shortened development and approval timelines. We also expect this to facilitate the early entry of domestic companies into the global market and expand exports."
* This article has been translated by AI.
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