Korea moves to ease biotech and medical data rules

The South Korean government has introduced a package of regulatory changes designed to make hospital medical data more accessible for new drug development and medical artificial intelligence research, while easing rules on drugs and advanced regenerative medicine. Announced at the second meeting of the Regulatory Rationalization Committee on 23 October, the measures aim to bring the country’s biotech regulatory framework in line with major competitor nations.

A central element is the plan to expand the use of safely pseudonymized medical information, which cannot be used to identify individuals, by lifting some of the bioethics review requirements that have applied even when data was pseudonymized. At the same time, the government is moving to adjust risk classifications and review systems in cell therapy and regenerative medicine to facilitate patient access and research activity.

The Ministry of Health and Welfare plans to exclude research using safely pseudonymized medical information from the scope of research involving human subjects. Under the current system, such research can require institutional review board confirmation even when personal identifiers have been removed; that step is to be waived for qualifying projects.

A blanket or broad consent framework will be introduced so that medical data collected for one study can be reused in subsequent research if certain conditions are met and participants’ rights, including the right to refuse, are preserved. The goal is to allow secondary use of genomic information and clinical data secured during clinical trials without requiring new consent each time, while relying on legal amendments to support this change.

Pseudonymization standards, which previously differed by medical institution, will be unified into national common standards covering structured and, over time, broader categories of medical data. Data analysis, once limited to on-site work inside medical institutions, will be expanded to a secure, cloud-based remote analysis environment so researchers can access and analyze data from outside facilities under defined safeguards.

Drug regulations will be revised so that medicines manufactured before receiving product approval can be sold after approval, provided they comply with good manufacturing practice standards and match the terms of the final approval. Until now, such pre-approval batches could not be marketed, which increased time and cost burdens between production and sales.

Review requirements for generic drugs will be eased. Generics with clearly established equivalence, such as water-soluble injections, will be exempt from submitting equivalence data, while products like ophthalmic ointments will be able to use alternative tests that better reflect product characteristics. For over-the-counter medicines with the same route of administration but minor formulation differences, such as tablets versus capsules or ointments versus creams, documentation requirements will be simplified in light of pharmacological effects and side-effect risks.

The Ministry of Food and Drug Safety also plans to draft separate review guidelines for new drugs developed with artificial intelligence, covering areas such as AI-assisted candidate discovery and toxicity prediction. The aim is to provide clear criteria for evaluating AI-related technology and data, improving regulatory predictability for companies.

In advanced regenerative medicine, the risk classification for certain autologous immune cell therapies, derived from a patient’s own blood and expanded in culture, will be lowered from medium to low risk when safety has been demonstrated through domestic and overseas literature and clinical data. Under the current framework, a preliminary clinical research phase lasting two to three years has typically been required before treatment; under the new system, treatment can proceed without that step if supporting materials are submitted and reviewed by the Advanced Regenerative Medicine Review Committee.

Supply channels for raw cells such as cord blood and embryonic stem cells will be broadened. Cells stored at cord blood banks and other external facilities, which were previously harder to access because cell processing facilities had to collect materials directly, will be made available for research and treatment, particularly in rare and intractable diseases.

The review system for advanced regenerative medicine will be restructured by separating committees according to risk level and introducing expedited review for identical or repetitive treatment plans. Additional pre-regulatory consultations and professional support staff will be offered to researchers, with the aim of shortening the time from study design to formal review.

Several elements of the package require changes to existing laws and regulations. A bill on the safety and support of advanced regenerative medicine and advanced biopharmaceuticals, intended to improve the review system in that field, has been submitted but has not yet passed the National Assembly. An amendment to the bioethics law that would permit wider secondary use of medical data has not been introduced.

The overall plan also includes support measures such as export assistance systems for biopharmaceutical contract development and manufacturing organizations and integrated review processes for digital convergence drugs. Alongside the deregulation steps, the government intends to implement safety management and misuse prevention measures to address potential risks related to patient safety and personal information protection.