"Biopharmaceuticals play a key role in protecting human health and life amid global aging and the risk of newly emerging infectious diseases. The Ministery of Food and Drug Safety of the Republic of Korea is accelerating regulatory support for biopharmaceuticals and international regulatory harmonization."Oh Yu-Kyoung Minister of Food and Drug Safety
The 2026 Global Bio Conference (GBC), hosted by the Ministery of Food and Drug Safety, opened on the 26th at the Grand InterContinental Parnas in Seoul.
GBC marks its 12th year. This year's theme is "big leap in bio, accelerating innovation." It will discuss the role of regulation and ways to strengthen international cooperation so that rapidly advancing technologies such as artificial intelligence (AI) and advanced biopharmaceuticals can lead to real product development and patient care.
Oh Yu-Kyoung, the Ministery of Food and Drug Safety chief, said in her opening remarks, "Biopharmaceuticals in the Republic of Korea have grown mainly in the fields of biosimilars and contract development and manufacturing (CDMO)," and noted, "We are laying the institutional groundwork to support regulation of biopharmaceuticals and CDMOs, closely communicating with the field and preparing follow-up measures."
She added, "We have established a regulatory innovation framework to shorten the approval and review period for biosimilars, innovative medical devices, and new drugs to 240 days, a world-class level, and have been implementing it since Jun.," and emphasized, "We are also leading international regulatory harmonization by rationalizing phase 3 clinical trial regulations for biosimilars."
President Lee Jae-myung also said in a congratulatory address read by Minister Oh, "The bio industry is emerging as a core of health security beyond the health and medical sphere and is growing into a key future industry driving the global economy through convergence with AI and the development of advanced new drugs."
Lee said, "For a bigger leap in the bio industry, we need to speed up partnership-based regulatory innovation grounded in safety," and added, "I hope this GBC will serve as a catalyst to activate communication among governments, industry, and academia in each country and to promote cross-border cooperation."
Baek Young-ok, chair of the Korea Biomedicine Industry Association, which organized the event, said, "Now it is important not only to generate innovation but to speed it up so it can actually reach patients and the market," and added, "Not only technological prowess but also regulatory responsiveness, manufacturing competitiveness, and global cooperation capabilities are determining industrial competitiveness."
About 5,000 people from domestic and overseas biopharmaceutical regulatory authorities, the pharmaceutical and bio industries, and academia will participate in the event, which runs through the 28th.
On the opening day, Lee Sang-yeop, vice president for research at Korea Advanced Institute of Science and Technology (KAIST), Jeremy Farrar, assistant director-general of the World Health Organization (WHO), Azad Bonni, senior vice president and global head of neuroscience and rare diseases at Roche pRED, and David Nogales, head of technology strategy at Merck in Germany, will deliver keynote speeches.
On the 27th-28th, expert forums will be held on topics such as vaccines, recombinant gene medicines, and biopharmaceutical supply chains. Development of antibody therapeutics using AI, non-animal testing methods, and fast-track approval and review measures will also be key agenda items.
This year, for the first time, "GBC Special: K-bio innovation leaders talk" was arranged, where heads of domestic bio companies will directly share their successes, challenges, and overseas expansion strategies.
One-on-one meetings between overseas regulatory agencies and domestic corporations will also take place. Representatives from overseas regulatory bodies in Canada, Japan, and Singapore will meet with domestic corporations to discuss overseas expansion strategies, and they plan to discuss regulatory issues by sector and review cooperation measures with the WHO, the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), and the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan.