Risk Management Plans to Cover All Growth Hormone Products as MFDS Strengthens Safety Oversight

The Ministry of Food and Drug Safety (MFDS) will strengthen safety oversight of growth hormone products starting Sept. 1 by applying risk management plans to all products in the category.

On the first, the MFDS said it would apply risk management plans (RMPs) to all 21 products from eight companies containing somatropin, which patients self-administer under a physician’s prescription and guidance.

A risk management plan is a comprehensive safety management plan for new drugs and orphan drugs that outlines information to be collected on safety and efficacy, pharmacovigilance and risk minimization measures.

Under the measure, marketing authorization holders must directly distribute patient medication guides and informational materials for health care professionals to medical settings.

They must also evaluate the results of implementing the risk management plans, including reports of adverse events from South Korea and abroad, annually and submit them to the MFDS.

Growth hormone products are prescription drugs used to treat growth disorders in children with growth failure due to growth hormone deficiency or Turner syndrome, as well as in children with idiopathic short stature.

Data from the Health Insurance Review and Assessment Service show that prescriptions for these products rose steadily, from 895,011 in 2020 to 1,621,154 in 2024.

The MFDS determined that, given the self-injectable nature of these products, a management system is needed to provide accurate information on proper administration and storage, as well as potential adverse events.

After discussions with the relevant industry beginning early this year, the agency required risk management plans to be developed and submitted for all growth hormone products marketed in South Korea under Article 32-2 of the Pharmaceutical Affairs Act and related provisions.

The MFDS said it expects the measure to further strengthen safety management of these drugs. It added that it will provide information on proper use within the approved indications and work to ensure the effective implementation and management of risk management plans.