Food and drug safety ministry publishes regulatory guide for advanced biopharmaceuticals

South Korea's food and drug safety ministry said it has published regulatory education materials for companies developing advanced biopharmaceuticals, aimed at helping researchers and venture firms prepare clinical trial applications and product approvals.

The content, posted on the ministry's nedrug.mfds.go.kr portal and open to anyone, covers review standards and required submission documents, guidance on writing review materials, and regulatory support programs. It breaks the review standards and document requirements down by quality, non-clinical and clinical categories, and includes instructions for preparing clinical trial plan approvals and product license applications. The materials also direct developers to the ministry's pre-consultation service and regulatory support programs.

The ministry said the materials are aimed particularly at researchers and venture companies in the early stages of development, which often lack regulatory experience or dedicated specialists.

"Advanced biopharmaceuticals are a field where regulatory information and consultation are important during development because of their technological characteristics," the ministry said in a statement. "We hope this content will help researchers and venture companies prepare the materials needed for clinical trial plan approval and product licensing more accurately and reduce the trial and error they experience during development."

Advanced biopharmaceuticals covered by the guidance include cell therapies, gene therapies and tissue-engineered products.

The ministry said it plans to keep updating the content in line with changes in technology and the regulatory environment and to expand the regulatory information it provides to reflect what developers need in the field. The content was released on Oct. 19.