Korea’s Ministry of Food and Drug Safety (MFDS) is expanding regulatory support for developers of cell and gene therapies by broadening its pre-consultation program to include products in the nonclinical stage. Previously, the service mainly focused on companies preparing for clinical trials. The National Institute of Food and Drug Safety Evaluation (NIFDS) has also recruited a new team of regulatory consultants with expertise in CMC, clinical development, and regulatory review in the cell and gene therapy area. The agency said the consultants will provide product-specific guidance throughout development, including support for IND filings and marketing approval applications. Officials expect the expanded program to improve access to tailored regulatory advice for companies developing advanced biopharmaceuticals, including cell and gene therapies and tissue-engineered products.
The Korean MFDS also recently announced a major update to its medical product approval system to help patients gain faster access to new treatments and to strengthen the country’s healthcare industry. Starting next month, the average review time for products such as new drugs, biosimilars, and innovative medical devices is expected to decrease from about 420 days to 240 days. To support this change, the MFDS will increase the number of reviewers in the bio-health sector from 369 to 564 and shift to a parallel review process so that different review teams can evaluate applications at the same time. The agency will also expand pre-application consultations and provide detailed checklists covering areas such as GCP, GMP, and risk management plans to help companies prepare stronger submissions and reduce delays.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.