Oh Yu-Kyoung, head of the Ministery of Food and Drug Safety, cited the enactment of the special law to support regulation for contract development and manufacturing (CDMO) of biopharmaceuticals as a key achievement in industrial regulatory reform this year. She said the agency plans to establish a "cybersecurity guideline" for AI and digital medical devices next year.
Oh Yu-Kyoung, the Ministery of Food and Drug Safety chief, said at a press briefing with the press corps held in Gwanghwamun, Seoul, on Dec. 11 in the afternoon, "This year was the year we laid the institutional groundwork to support global expansion in the bio and medical device sectors," as she outlined this year's key achievements and next year's plans.
The Minister picked the enactment of the special law to support CDMO regulation as a major achievement this year. The law includes a pre-certification system and regulatory fast-track needed for Korea's biosimilar (biopharmaceutical copy drug), vaccine, and cell and gene therapy corporations to export.
The Minister said, "At the president-led K-bio roundtable on Sep. 9, we codified the industry's requests for export certification and regulatory support," adding, "It reflects the government's strong will to support that the Ministery of Food and Drug Safety prepared a fiscal law for a specific industry."
She also presented the regulatory direction for medical artificial intelligence (AI). The Minister said, "Korea is the first country in the world to create the Digital Medical Products Act and guidelines for Generative AI medical devices," adding, "Next year, we will newly prepare cybersecurity guidelines for AI and digital medical devices and expand on-site regulatory briefings that directly visit regional ventures and small and mid-size companies."
The Minister said, "Our goal is to provide more specific and friendly guidance so that startups developing AI medical devices can clearly understand 'how far they must meet' (for cybersecurity)." The Minister added, "Regulation is not a large nail that blocks industry but a safe fence that protects the public's peace of mind."
She also expressed her view on the pros and cons surrounding prescribing by generic name. Prescribing by generic name is a system in which a doctor prescribes using the active ingredient name instead of a specific drug's brand name.
Currently in Korea, doctors prescribe specific drugs and pharmacists dispense them. If the generic-name prescribing system is introduced, a pharmacist can choose one among several drugs with the same ingredients listed on the prescription and dispense it. For example, instead of the product name "Tylenol," the ingredient name "acetaminophen" would be written, and the pharmacist could dispense a generic drug with the same ingredient.
Doctors oppose expanding prescribing by generic name. Some in the medical community also worry that "the government is trying to expand prescribing by generic name to effectively broaden pharmacists' authority to substitute."
Earlier, at the National Assembly Health and Welfare Committee's Oct. audit, the Minister said, "Drugs with the same ingredients whose equivalence has been proven by bioequivalence testing have the same efficacy," adding, "While controversy over doctors' prescribing authority falls under the Health and Welfare Ministry, the Ministery of Food and Drug Safety, as the regulator, will strictly maintain equivalence standards."
Again on this day, the Minister said, "The principle is that drugs are dispensed as the doctor prescribes, and there is no intent to undermine doctors' expertise." The Minister added, "However, considering patient safety and drug supply conditions, it is only at the level of clearly guiding the options that doctors can choose for same-ingredient, same-strength medications." The Minister said, "If institutional changes are needed, we will decide in close consultation with the medical community, and we do not intend to create anxiety on the ground."
She also addressed the issues of misuse of obesity treatments such as Mounjaro and Wegovy, and the issue of bringing them in from overseas. The Minister explained, "We are already blocking at the source purchases brought in from overseas like travel souvenirs," and "even when small quantities are brought in with prescriptions obtained directly overseas, the Korea Customs Service strictly checks documentation requirements."
The Minister said, "Wegovy and Mounjaro have already been excluded from eligibility for telemedicine prescriptions," adding, "In cooperation with the Education Ministry, we will respond strictly on multiple levels through preventive education for adolescents, constant monitoring by the Ministery of Food and Drug Safety's Cyber Investigation Unit of illegal online ads, and online blocking linked with the Korea Communications Standards Commission."
On the surge of exaggerated and false ads generated by AI, the Minister said, "We are pushing to revise the law to clearly define the illegality of AI-enabled advertising." The Minister said, "One cannot evade responsibility just because the content was made by AI," adding, "We will overhaul the system to clarify accountability and minimize consumer harm."
The Minister said, "Multiple ministries are jointly preparing measures to drastically shorten the current process—which takes an average of 52 days from when the public reports illegal online ads to platform blocking—to within 24 hours."
The Minister emphasized, "The most important mission of the Ministery of Food and Drug Safety is to firmly protect public safety," adding, "We will conduct reviews and regulations in the medical device and bio sectors more tightly to meet international standards."