Advanced Biological Products

Proposed enactment to the "Advanced Biological Products Act" (57 page(s), in Korean)

The purposes of the Advanced Biological Product Act are to: (a) establish a safety control system that covers the whole product life cycle (b) stipulate the list of advanced biological products which are subject to accelerated approval and its procedure.

Article 2: definition(s)

Designates cell therapy products, gene therapy products, tissue-engineered products, combined advanced therapy medicinal products and other products recognized by the Minister of Food and Drug Safety as advanced biological products.

Also, the same article provides definitions of human-derived cells, etc. and management control of human-derived cells, etc.

Article 15: Importation of advanced biological product

Any person who intends to import advanced biological products shall declare import business and obtain import permission per each product.

From Article 16 to Article 19: Management control of advanced biological product

Any person who intends to engage in management control of human-derived cells shall obtain an approval from the Minister of Food and Drug Safety.

Establish a compliance list for collection of human-derived cells and control and prevention of advanced biologics products-induced diseases.

From Article 21 to Article 25: Handling of advanced biological product

The Minister of Food and Drug Safety may designate an advanced biological product as a product subject to long-term follow-up investigation should it deem an investigation is required to examine the association between the adverse event and administration of the product.

If investigation of adverse event is deemed required, the administered advanced biological product may be designated as a product subject to long-term follow-up investigation, the adverse event shall be investigated, and the product's administration record shall be kept. Stipulates requirements for packaging, container, and package insert of advanced biological products.