Regulator revises rules for swift approval of high-tech bio drugs

Shim Hyun-tai  Published 2020.07.03  18:04  Updated 2020.07.03 18:04


The Ministry of Food and Drug Safety has worked out new rules to screen and approve up-to-date biopharmaceutical products, such as cell therapies and genetic treatments, swiftly and smoothly, while minimizing their safety problems.

It put the revised rules on prior notice and will collect opinions from related parties until July 23.

The ministry said it has systemized data that needs reviewing for applicants' convenience, according to the formation of Common Technical Documents (CTD).

The Ministry of Food and Drug Safety has worked out new rules for approving advanced biomedicines more quickly and smoothly. (MFDS)

The CTD is an international standardized form of data required for the application for drug approval by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). It consists of quality evaluation, non-clinical studies, and clinical trial data.

If the ministry needs to observe for more than a specified period considering the type of treatment and clinical trial results, the products would be designated as a long-term follow-up target.

The investigation period can be set between five to 30 years. For instance, the ministry has to examine stem cell therapy for less than five years, gene therapy for up to 15 years, and advanced biomedicine, including animal tissue and cell, for up to 30 years.

Besides, the new rule includes established requirements for submitted data to designate the target as a product for fast-track screening.

The medicines subject to fast-track procedures are limited to drugs for treating deadly illness without substitutes, rare diseases, and infectious diseases.

Licensed items that fall under this category must be licensed again according to the new regulations. Sixteen cell therapies can be such targets, ministry officials said.

Advanced drugs such as Chimeric antigen receptor-T (CAR-T) that use cells also have to go through the examination.

“We hope businesses and experts present various opinions on this proposal so that advanced bio-therapeutics such as cell and gene therapies can remain competitive in the global market through a thorough approval and examination process,” Minister of Food and Drug Safety Lee Eui-kyung said.

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