Regulatory Support Schedule for Advanced Biopharmaceuticals Announced

National Institute of Food and Drug Safety Evaluation Releases “CELL-UP Calendar” Covering 70 Regulatory Support Programs, Including Training, Consulting, and Industry Meetings

[Medical Newspaper · Ilgan Bosa — Reporter Lee Jeong-yoon] — A new calendar has been released providing an at-a-glance overview of this year’s regulatory support programs for the development of advanced biopharmaceuticals.

The National Institute of Food and Drug Safety Evaluation (NIFDS), led by Director Park Yoon-joo, announced on the 12th that it had released the “2024 CELL-UP Regulatory Support Program Calendar” to support the development of advanced biopharmaceuticals.

CELL-UP is a collaborative regulatory support initiative established on December 4, 2023, bringing together six organizations led by the Ministry of Food and Drug Safety to provide integrated regulatory support services for the commercialization of advanced biopharmaceuticals.

The six participating organizations are the Ministry of Food and Drug Safety (NIFDS), the Korea Regenerative Medicine Fund (KFRM), the Osong Medical Innovation Foundation, the Foundation for Regenerative Medicine, the Korea Regulatory Science Center, and the Korea Biopharmaceutical Industry Association.

The CELL-UP Calendar includes plans for 70 programs to be provided by the six organizations during 2024, covering areas such as training, consulting, regulatory counseling, and industry roundtables.

Major programs include joint inter-agency meetings, the Bio Challenger program, training for manufacturing and import managers, and basic and advanced regulatory training courses for researchers.

The Bio Challenger program is an MFDS initiative designed to support the commercialization of Korea’s first domestically developed advanced biopharmaceuticals based on innovative concepts and technologies.

Director Park said, “We expect the CELL-UP Calendar to provide regulatory support services in a more systematic and predictable manner and help accelerate the commercialization of advanced biopharmaceuticals.”

She added, “NIFDS will continue to actively support the development of advanced biopharmaceuticals based on its regulatory expertise.”

Source: Medical Newspaper · Ilgan Bosa(http://www.bosa.co.kr)