The Ministry of Food and Drug Safety (MFDS) has completed a regulatory overhaul to accelerate biosimilar approvals by establishing a legal basis for expedited reviews. The move institutionally underpins the agency's earlier policy to shorten approval timelines.
The MFDS said Sunday it has revised and enacted the "Regulations on Product Approval and Review of Biological Products," which now explicitly includes biosimilars as eligible for expedited review.
The core of the revision is clarifying the administrative grounds for fast-track biosimilar approvals. By designating biosimilars in the regulations — previously excluded from expedited review — the agency has secured an institutional foundation for granting review priority.
The revision follows this year's reduction in biosimilar approval timelines from 406 days to 295 days. The combination of shorter approval periods and a formal legal basis for expedited review is expected to produce tangible improvements in actual review speed.
Manufacturing process change procedures were also streamlined. Previously, most changes to manufacturing methods required formal approval amendments. Going forward, changes with minor impact on quality can be handled through pre-market reporting or post-market reporting via annual reports. Examples include changes to containers, packaging, or process nomenclature.
The MFDS explained that the revision will reduce the administrative burden on companies while maintaining quality and safety standards. The agency noted that the changes are particularly meaningful given the frequent process improvements characteristic of biopharmaceuticals, and are expected to enhance development and production efficiency.
Industry observers view the revision as significant not only for improving approval speed but also for increasing the predictability of the regulatory framework. The measures are seen as a systematic overhaul of the approval and change management system rather than a simple deregulation.
"This revision aims to support the development of the biopharmaceutical industry while rationally reorganizing the approval system," an MFDS official said. "We will continue to improve the system going forward."