[Edaily Reporter Kim Jinsoo ] As cell-free allogeneic dermal-based extracellular matrix (ECM) skin boosters are reshaping the market, regulatory authorities are taking steps to strengthen safety measures. Rather than creating a new regulatory framework, the authorities have decided to ensure safety within the existing Human Tissue Act. Consequently, the impact of these safety measures on human tissue product manufacturers is not expected to be significant.

According to the pharmaceutical and biotech industry on the 12th, the Ministry of Food and Drug Safety (MFDS) recently announced a proposed amendment to the Rules on Human Tissue Safety. It has been confirmed that, under the proposed amendment, manufacturers of ECM skin boosters and other relevant companies will be required to report adverse events related to the use of human tissue twice a year. This measure addresses recent safety concerns raised regarding ECM skin boosters.

The MFDS has already stated its position that ECM skin boosters based on acellular allogeneic dermis are human tissues. Accordingly, it is analyzed that the MFDS has established a regulatory framework focused on measures to ensure safety within the existing Human Tissue Act, rather than creating entirely separate regulations for the safety management of ECM skin boosters.

An MFDS official stated, “We are currently gathering feedback from companies and plan to decide by the end of this month whether to incorporate the comments received,” adding, “Following a review by the Ministry of Government Legislation and other procedures, the regulations are expected to take effect by the end of this year.”

Side Effect Reporting Requirements Strengthened from Once to Twice a Year

Human tissue products are regulated under the “Act on the Safety and Management of Human Tissue” (Human Tissue Act). According to the Human Tissue Act, tissue banks are required to document matters related to donation, management, and transplantation and report them to the MFDS once a year. Furthermore, the Act stipulates that tissue banks and medical institutions performing tissue transplants must conduct follow-up surveys after human tissue transplants and report the results, including any adverse reactions, to the MFDS.

Amid this, the Ministry of Food and Drug Safety (MFDS) moved last month to amend the regulations on human tissue safety. Specifically, to strengthen safety management of ECM skin boosters, the amendment includes a provision to increase the frequency of safety reports—which were previously submitted “once a year” for general adverse events—to “once every half-year,” thereby raising the annual frequency to twice a year.

Reporting regulations for “serious adverse events,” in addition to general adverse events, are already established under the Human Tissue Act. Serious adverse events include the following three categories: △ the occurrence of an infectious disease; △ the metastasis of a malignant tumor; and △ an infection resulting from tissue contamination. If any of these three types occur, immediate reporting within seven days is mandatory.

In addition, the draft amendment to the Human Tissue Materials Regulations announced by the Ministry of Food and Drug Safety (MFDS) includes provisions such as △specifying the purpose when reporting use, △restrictions on advertising for cosmetic purposes, and △requiring medical institutions to inform patients that the product is of human origin.

An MFDS official stated, “This amendment to the regulations pertains to matters that the MFDS can address on its own, and we are continuing discussions with the Ministry of Health and Welfare and other relevant agencies within a broader framework.”

Conducting Independent Safety Verification as Well

L&C BIO(290650)and HANS BIOMED CORPORATION(042520), leading domestic ECM skin booster brands, maintain that they are fully prepared for the MFDS’s enhanced safety measures. Since they have already been submitting adverse event reports annually, they assert that increasing the frequency to twice a year will not significantly change their operations.

Furthermore, L&C BIO is taking proactive measures to ensure quality, such as undergoing various procedures to verify safety independently and conducting research.

An L&C BIO official stated, “When it comes to human tissue, it is more important not only to identify adverse reactions after use but also to select only safe tissue from the outset and verify each processing step to manage risk factors at the source,” adding, “We are applying a multi-verification system that involves double-checking not only from a quality control perspective but also from a medical standpoint.”

L&C BIO does not stop at merely meeting legal standards; to ensure an even higher level of safety, during the donor eligibility assessment stage, the raw tissue is first screened by the QC team and medical managers at a U.S. tissue bank, and then re-screened by L&C BIO’s own QC team and medical managers in accordance with internal standards.

HANS BIOMED CORPORATION also projected that there would be no safety concerns moving forward, as “BellaCell HD,” a sheet-type skin graft made from the same raw material as CellDiem, has been confirmed to be safe in numerous research papers.

In particular, regarding human tissue products, the company maintains that it is fully capable of responding to any potential adverse effects—even in the unlikely event they occur—since management systems are in place not only to report adverse events but also to track donor information, as well as the history of processing, testing, storage, and distribution, all to ensure safety.

Furthermore, while some have raised concerns about the possibility of surfactant residues arising from the decellularization process, test results from the Korea Testing & Research Institute (KTR) confirmed that all lots were “below the detection limit,” indicating that no surfactants were detected.

An L&C BIO official stated, “Human tissue has already been used in countless applications, and the safety of skin grafts has likewise been proven,” adding, “The fact that a more rigorous management system is being established—along with institutional improvements such as shortening the reporting cycle for adverse reactions and strengthening the patient reporting system—can actually be viewed positively.”