[Asia Economy Reporter Cho Hyun-ui] K-Bio, which laid the foundation for growth amid the COVID-19 pandemic, is facing urgent calls for regulatory improvements to strengthen its global competitiveness.
On the 18th, industry insiders pointed out that the new medical technology assessment, identified as a representative dual regulation, has seen no tangible changes felt by companies despite the government's efforts to improve various systems. Last year, the government introduced measures to shorten market entry time, such as reducing the new medical technology assessment period from 280 days to 250 days after application, introducing a pre-entry and post-assessment system, and conducting insurance listing reviews simultaneously.
An industry official said, "President Moon Jae-in promised to resolve this, but nothing has changed on the ground," adding, "Even if safety and efficacy are verified according to the improved procedures, the process is still too lengthy, so it takes a long time to launch products even after obtaining approval."
There are also calls to relax the qualification requirements for pharmaceutical manufacturing managers, who must be licensed pharmacists or Korean medicine pharmacists. Since this work does not necessarily require the expertise of a pharmacist, the industry demands improvements to allow personnel with over 10 years of experience in quality control (QC) or quality assurance (QA) to qualify.
An industry insider lamented, "Companies have to offer high salaries to hire pharmacists, which is a heavy burden, and many pharmacists are reluctant to work at factories located in small and medium-sized enterprises or rural areas, making recruitment difficult."
Remote medical care, which was expected to improve regulations with the temporary allowance of telephone prescriptions and consultations, remains stagnant. In Korea, except for remote medical consultations where doctors consult other doctors in different regions, the principle is 'direct examination (face-to-face consultation)' where doctors and patients meet directly.
However, overseas, legal barriers to introducing remote medical care are rare. In the United States, telemedicine accounts for one out of every six cases, indicating its popularization, and there are criticisms that Korea is falling behind. An industry official said, "Due to high regulatory barriers domestically, Korean companies with excellent technology are actually seeking opportunities not in Korea but in other countries."
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