Starting in February next year, not only new drugs using domestic ingredients but also medicines that have changed their imported ingredients to domestic ones will be eligible for price benefits.
On the 24th, the government held the '5th Biohealth Innovation Committee' at the Government Seoul Building, chaired by private vice chairman Kim Young-tae, president of Seoul National University Hospital, to discuss improvements on 35 regulatory issues, including this one.
According to the improvement plan discussed that day, when changing the already registered drug ingredients from imported to domestic, the price benefits will reflect the cost increases, similar to those for new drugs using domestic ingredients. To this end, the Ministry of Health and Welfare plans to revise the 'regulations on the evaluation criteria and procedures for whether drugs are subject to health insurance coverage' in February next year.
Pharmaceutical companies can apply for adjustments to the maximum price increase for the products if they change the ingredients of generics (copy drugs) specified as essential national medicines to domestic ones, and they can receive price benefits after a review by the Drug Reimbursement Evaluation Committee.
Additionally, the Ministry of Health and Welfare will amend the enforcement decree in February next year to flexibly apply the risk classification of low, medium, and high risks as specified in the Act on Advanced Regenerative Medicine, considering the safety of each case. In the case of high-risk clinical studies, if sufficient research data exist and safety is deemed high, the process for adjusting the risk level will allow for reclassification to medium risk for treatment technologies. This is expected to reduce administrative burdens and promote research.
That day, the Biohealth Innovation Committee reviewed the domestic technology situation in the fields of advanced regenerative medicine and messenger ribonucleic acid (mRNA) vaccine development, and discussed future directions including inter-agency support measures. The committee unanimously agreed that sustainable and stable national support for research and development in the field of regenerative medicine is essential for the successful development of cell and gene therapies.
They also emphasized the need to focus on infrastructure development to strengthen capabilities in the domestic regenerative medicine sector, including contract manufacturing organizations (CMOs), contract development and manufacturing organizations (CDMOs), and clinical trial organizations (CROs), while easing regulatory burdens for the rapid commercialization of domestically developed cell and gene therapies. They urged that efforts be made to gather both public and private capabilities to secure mRNA vaccines without disruptions by 2028.
Kim Young-tae, vice chairman of the Biohealth Innovation Committee (president of Seoul National University Hospital), stated, 'Today's meeting discussed the current status of technology ownership and support measures for promoting clinical entry of cell and gene therapies and mRNA vaccine technology development,' and added, 'Regulatory improvement is one of the most important agenda items for the Biohealth Innovation Committee, and I will work to ensure that improvements can be felt on the ground.'
In the future, the Regulatory Reform Office within the Korea Health Industry Development Institute will identify regulatory reform tasks and plan to disclose the results of reviews of tasks reported to the Innovation Committee through the Regulatory Reform Office's website.