[의학신문·일간보사=이정윤 기자] In the future, the duty to store samples for imported drugs and the conditional approval requirements for drug manufacturing industries will be relaxed.
The Ministry of Food and Drug Safety (Director Yoo-kyung Oh) announced on the 10th that the ‘Measures to improve regulations for new industry difficulties’ were finalized at the Regulatory Reform Committee on the 10th, and six tasks to improve regulations in the new bio-healthcare industry were being implemented.
The Ministry of Food and Drug Safety (MFDS) decided to improve procedural regulations that are burdensome for business operators but have little relevance to safety in the licensing process, such as pharmaceuticals, to support market vitalization in the bio-healthcare sector.
Among the major tasks pursued by the Ministry of Food and Drug Safety, two cases were included in the pharmaceutical sector: ▲ easing the duty to store samples for imported drugs and ▲ easing conditional licensing requirements for drug manufacturing industries.
The Ministry of Food and Drug Safety is obliged to store a certain amount of samples for imported drugs. We plan to ease the obligation to store specimens after conducting a management status survey.
In particular, in the case of high-priced drugs imported in small quantities, such as anticancer drugs and orphan drugs, it was difficult to supply sufficient drugs to patients who were desperate for them due to the storage obligation.
The Ministry of Food and Drug Safety said, “As of April of this year, 395 orphan drugs were supplied (359 imported and 36 manufactured). expected
In addition, in the case of conditional permission for facilities in the pharmaceutical manufacturing industry, permission was only possible when a new building was used when there was land ownership. .
For the purpose of preventing property loss, ‘at the time of permission after initial facility’ for special preparations and large facilities, a facility conditional permit system was in operation, which permits the establishment of facilities within a certain period of time when permitting pharmaceutical manufacturing.
However, in the case of using an existing building, conditional permission is granted by submitting a lease contract, even if you do not own the building.
When this improvement measure is completed, it is expected that the new drug business will be revitalized by relieving the inconvenience of drug manufacturers.
The Ministry of Food and Drug Safety (MFDS) said that it will promptly discover and improve regulations that do not meet international standards or reflect changes in the industrial environment.
In addition, he added that he will strive to create tangible results that can be felt by the public and businesses by continuously promoting regulatory improvement in the direction of strengthening the autonomy and responsibility of the private sector by expanding the comprehensive negative regulatory system.