Dynamic Bio, a public-private collaboration platform for the biopharmaceutical sector jointly built by the Ministry of Food and Drug Safety (MFDS), industry and academia, has marked its 15th anniversary. The MFDS held a commemorative event on May 27 at the Atlas Hall of The Westin Josun Seoul Parnas in Gangnam-gu, Seoul, co-hosted with the Korea Biopharmaceutical Association under the theme "15 Years Built Together, Envisioning the Future of K-Bio Together."
Dynamic Bio is a public-private consultative body designed to develop policies and identify regulatory improvement tasks related to biopharmaceutical industry support. It is organized into nine subcommittees — biopharmaceutical policy development and stable supply, advanced bio policy development, biological products, recombinant DNA products, advanced biopharmaceuticals, next-generation therapeutics, Good Manufacturing Practice (GMP), export support, and biosimilars — with a total of 583 members. The platform has been credited with driving K-Bio achievements through joint government-industry discussions on regulations and guidelines.
MFDS Commissioner Oh Yu-kyoung said in a congratulatory address, "We will continue to support K-Bio through Dynamic Bio so that the voice of industry and policy remain connected, enabling K-Bio to build world-class competitiveness in safety and quality and advance beyond Korea onto the global stage." She added, "Dynamic Bio has played a major role in the research, development, approval and export of biopharmaceuticals over the past 15 years."
The MFDS explained that by reflecting outcomes discussed at Dynamic Bio, it has achieved a total of 101 regulatory improvements in the biopharmaceutical sector, including enactments and revisions of laws, public notices and guidelines. "As a result of communication with industry, outcomes such as the special act on regulatory support for contract development and manufacturing organizations (CDMOs) and a draft guideline on streamlining Phase 3 clinical trials for biosimilars were made possible," Commissioner Oh said.
The event also featured commendations for outstanding companies, case study presentations, a special lecture and introductions of new subcommittee chairs. In the corporate category, Chong Kun Dang Bio received the MFDS Commissioner's commendation for contributing to the development of quality guidelines for clinical trials of live biotherapeutic products. In the individual category, Jung Mi-hyun, head of division at CTX, and Shin Jung-sub, executive director at Ubio Logics, each received commendations.
During the corporate best-practice presentations, timely supply through regulatory improvement was emphasized. Shin Yoon-chul, head of the development team at GC Biopharma and chair of the biological products subcommittee, said, "The testing procedures for national lot release approval for export products have been substantially shortened, allowing us to meet delivery deadlines more reliably and contributing to increased K-Bio exports." Kim Sang-hyun, head of external cooperation at Hugel, also noted, "The processing period for national lot release approval has been reduced by 27.8 days on Hugel's basis, establishing a foundation for timely market supply."
Lee Myung-hwa, director of the Global Strategy Division at the Science and Technology Policy Institute (STEPI), who delivered a special lecture, assessed that limitations in bio-industry-related policies still exist. Specifically, she pointed to declining new fund formation for biotech, low self-sufficiency in active pharmaceutical ingredients, vulnerable supply chains and falling clinical competitiveness. "We need to establish stage-specific dedicated funds for biopharmaceuticals to address the liquidity constraints felt by startups and others, while reducing the export concentration on China and India and expanding supply chains," Lee said.
The MFDS plans to continue pursuing reasonable regulatory improvements through public-private collaboration channels including Dynamic Bio. Key agenda items include developing guidelines to streamline Phase 3 clinical data submission requirements for biosimilars, and improving procedures to allow pre-market reporting or post-market reporting through annual reports when manufacturing method changes for biopharmaceuticals have a low impact on quality.
