MFDS Revises Medical Product Development Consultation Casebook... 366 Recent Consultations Added

[Financial News] The Ministry of Food and Drug Safety's National Institute of Food and Drug Safety Evaluation has revised the 'Collection of Consultation Cases on Medical Product Development.' This is intended to support companies and researchers in reducing trial and error and accelerating commercialization during the development of new technology drugs, biopharmaceuticals, and medical devices.
According to the Ministry of Food and Drug Safety on the 23rd, this casebook newly includes 366 consultation cases conducted through the 'Innovative Product Pre-consultation' from August last year to July this year. By category, there were 152 cases of pharmaceuticals, 155 cases of biopharmaceuticals, and 59 cases of medical devices.
In the pharmaceutical sector, it contains 40 consultation cases regarding quality, 73 regarding non-clinical trials, and 39 regarding clinical trials. The non-clinical trials consisted of 30 cases regarding pharmacology and 43 regarding toxicology. For biopharmaceuticals, 57 cases regarding quality, 69 regarding non-clinical trials, and 29 regarding clinical trials were included. For medical devices, 33 cases regarding technical documents and 26 regarding clinical trials were included.
In the field of pharmaceuticals and biopharmaceuticals, guidance was provided on considerations for each of the quality, non-clinical, and clinical stages during the development of new technology medical products, such as novel targeted immune disease treatments, radiopharmaceuticals for rare cancers, and intranasal vaccines.
In the field of medical devices, it includes specific technical documents and clinical trial consultation cases, such as the procedure for verifying whether bone graft materials qualify as convergence medical products, the method of applying for designation as an innovative medical device and support programs, and the scope of submission of clinical trial data for temporary crown resins.
In addition, details regarding regulatory support, such as the eligibility, application methods, and procedures for pre-consultation on innovative products, were provided, along with information on the 'Innovative Product Pre-consultation Hotline' newly established this year.
"We expect that through this revision of the casebook, companies and researchers developing similar medical products will be able to refer to actual consultation cases," said an official from the Ministry of Food and Drug Safety. "We plan to continue supporting the rapid commercialization of medical products by providing customized consultations at each stage, from R&D to approval."

[email protected] Jeong Sang-hee Reporter