Regulatorische Updates

Analysis shows 82% of the Ministry’s 177 websites and apps are accessibility certified, leaving 18% uncertified as of August 2026.

The Korean government is reviewing a plan to extend prescription drug delivery to all telemedicine patients, prompting worries among community pharmacists about competition from large warehouse‑type pharmacies and digital platforms.

As telemedicine becomes formalized, discussions are moving toward prescription, dispensing, and medication delivery, highlighting public safety and regulatory challenges.

The MFDS will host a public‑private meeting on the 15th in Seoul to discuss regulatory and review processes for digital convergence medicines under the Digital Medical Device Act.

South Korea's Ministry of Health and Welfare announced a public hearing on the proposed Digital Healthcare and Health Information Utilization Support Act, inviting experts and the public to discuss key issues.

The ‘YakOlryeo’ platform offers up to 8% purchase benefits to pharmacies, prompting industry criticism that it exploits regulatory gaps and creates unfair competition.

The Korean Pharmaceutical Association urges prioritizing secure patient‑institution data linkage rather than expanding private sector use of medical data, emphasizing safety and professional roles.

Experts argue that individual regulatory tweaks are insufficient and urge a dedicated law with clear standards to foster trust and activation of medical data under the Digital Healthcare Act.

The Pharmaceuticals and Medical Devices Agency (PMDA) announced a new project team to develop guiding principles for AI utilization, listed under its “Projects Across Multi‑Offices” initiative.