[Newsmp] The Ministry of Food and Drug Safety (MFDS) announced Monday that it would ease the requirement to store samples of imported rare drugs to expand treatment opportunities for patients with rare diseases and cancer.
This regulation also allows for the replacement of quality inspections of radioactive drugs with test reports from overseas manufacturers.
The previous requirement for importers of rare drugs to store drug samples was a burden on importers due to a high proportion of stored samples to sales volume for rare drugs and could lead to supply disruptions, the MFDS explained.
In response, the MFDS has revised the regulations to reduce the number of samples that must be stored for rare drugs. Under the new regulations, importers of small quantities of rare drugs are only required to store one sample for product identification, if they can prove that samples are stored in the manufacturing country or by the overseas manufacturer.
In addition to the challenges faced by other imported drugs, radioactive drugs for rare cancer patients have also faced challenges in conducting import-stage quality inspections promptly due to a lack of domestic testing facilities.
As a reaction to this issue, the MFDS would enhance regulations, enabling local importers of radioactive drugs with short-lived radioactive isotopes to skip quality inspections at the import stage if they possess test reports from the manufacturing country or the original manufacturer.
"The new regulations will help to increase the supply of rare drugs and speed up the supply of imported radioactive drugs to patients," the MFDS said. "We will do our best to expand patient access to treatment and ensure the stable supply of drugs."
