Drug development encouraged for rare diseases
By Yun Suh-young
The Korea Food and Drug Administration (KFDA) said Monday it will support the development of drugs to cure rare diseases and create a stable supply base for the pharmaceuticals.
Rare diseases are those which cannot be fully cured or do not have drugs to treat their symptoms.
The KFDA plans to induce local firms to engage in research and development of the much needed drugs.
“We will support the making of the drugs by designating potential drug substances or stem cell medicines as ‘developmental medicine for rare diseases.’ We also plan to expand opportunities for research centers to receive financial support from the government,” said a KFDA official.
The administration will also oversee the distribution and supply of the drugs by regulating their price and production and by creating a legal foundation to receive incentives once they’re designated as effective treatment for rare diseases.
Regarding issues of safety, the KFDA said it will create a standard for controlling the quality of the drugs by establishing a six year research period in which clinical trials to monitor side effects and other dangers will be held prior to their release on the market.
“We hope the new measures will boost the research and development of the drugs for rare diseases and expand the opportunities of patients with rare diseases to be cured through the distribution of the drugs,” the KFDA official said.
The safety standards and effectiveness of medicines for rare diseases are better than for those of existing substitute medicines, according to the KFDA.