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  • Janssen, granted permission to import advanced bio medicines
  • by Lee, Tak-Sun | translator Choi HeeYoung | Oct 21, 2021 05:14am
It seems that it is in a hurry to introduce cell and gene therapy such as CAR-T in Korea
Janssen Korea has obtained the second approval for the import business of advanced bio medicines after Novartis Korea. Janssen is also expected to introduce related products in the near future because advanced bio-medicine items designated by the MFDS can only be approved if it is approved for the advanced bio-medicines import business.

On the 18th, the MFDS approved Janssen Korea as an advanced bio-medicine importer. Advanced bio-medicine is a new category of medicines created when the Advanced Regenerative Medicine and Advanced Bio-medicine Safety and Support Act was enacted and enforced in August last year. Cell and gene therapy mainly belong to advanced bio medicines. Existing cell and gene therapy drugs have b
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