The South Korean government will ease rules so that medical data accumulated at hospitals can be used more readily for new drug development and medical artificial intelligence research. Drugs manufactured before product approval will be allowed on the market if they meet certain conditions, and review standards for generic drugs will be streamlined. The aim is to reduce the regulatory burden across the biotech industry, from research and development through production and sales.
The government announced a package of measures to bring biotech regulation in line with competing countries at the second meeting of the Regulatory Rationalization Committee, held at the Blue House guest house on the 23rd, according to the Ministry of Health and Welfare and the Ministry of Food and Drug Safety.
The welfare ministry will first exclude research using safely pseudonymized medical information from the scope of research involving human subjects. Under current rules, researchers must apply to an institutional review board for an exemption and receive confirmation even when personal data has been pseudonymized. That step will no longer be required. Research using human-derived materials or with a direct physical effect on patients will remain subject to existing review.
The ministry will also introduce a blanket consent system so that medical data collected for one study can be used in others, easing the burden of obtaining consent again while preserving participants' right to refuse. It will unify pseudonymization standards that currently differ by medical institution and set rules allowing data to be analyzed remotely in a cloud environment, without a visit to the hospital.
The drug safety ministry is revising rules on drug production and approval. Medicines manufactured before product approval could not be sold until now. They will be allowed on the market if they meet conditions including compliance with good manufacturing practice standards and manufacture identical to the terms of the final approval.
Reviews of generic drugs will also change. Products whose equivalence is clear, such as water-soluble injections, will be exempt from submitting supporting data, and eye ointments will be allowed alternative testing that reflects the characteristics of the product. In advanced regenerative medicine, the risk classification for autologous immune cell therapy will be lowered to low risk from medium risk, and the use of externally stored cord blood and embryonic stem cells will be expanded.
The question is how quickly the measures take effect. A bill on the safety of and support for advanced regenerative medicine and advanced biopharmaceuticals, intended to improve the review system for advanced regenerative medicine, has been introduced but has yet to clear the National Assembly, according to the welfare ministry. An amendment to the bioethics law allowing secondary use of medical data has not been introduced at all. An industry official said the package marks meaningful progress in strengthening the competitiveness of the bio-health industry, but stressed that the bills must pass quickly and follow-up changes to the rules must come swiftly for the effects to be felt in clinical practice.