'2025 New Technology and New Concept Global Drug Development and Commercialization Support Meeting'
to Be Held on the 13th at the Korea Press Center
The Ministry of Food and Drug Safety (MFDS) has selected 20 innovative products, including new drugs and advanced biopharmaceuticals, to support their rapid commercialization.
The National Institute of Food and Drug Safety Evaluation under the MFDS announced on the 12th that it will operate the 'Giljabi' program based on this plan. Giljabi is a system that selects 20 innovative products according to the 'Regulatory Science Innovation Act for Food and Drugs' and provides intensive consultations to help link them to approval.
For the 20 selected items, a dedicated product manager will be assigned to review the development process after preliminary consultations and provide expert advice. For those subject to clinical review, guidance will be given on clinical trial design appropriate to the development stage, the adequacy of non-clinical and clinical trial data, and statistical methods.
Additionally, support will be provided to assist in preparing approval documents in connection with the expedited review (GIFT) program, including pre-reviewing documentation standards if necessary.
Meanwhile, on the 13th, the MFDS will hold the '2025 New Technology and New Concept Global Drug Development and Commercialization Support Meeting' at the Korea Press Center in Jung-gu, Seoul, to provide information on systems such as Giljabi.
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