Japan's conditional early approval program for innovative cancer drugs: Comparison of the regulatory processes with the US FDA and the EMA

Murayama A 1 , Ueda M 2 , Shrestha S 3 , Tanimoto T 4 , Ozaki A 5

Affiliations 

  • 1 Medical Governance Research Institute, Minato-ku, Tokyo, Japan; Tohoku University School of Medicine, Sendai, Miyagi, Japan. Electronic address: [email protected]
  • 2 Medical Governance Research Institute, Minato-ku, Tokyo, Japan; Department of Orthopedic Surgery, Yokohama Rosai Hospital, Yokohama-shi, Kanagawa, Japan
  • 3 School of Pharmacy, Monash University Malaysia, Jalan Lagoon Selatan, 47500, Bandar Sunway, Selangor, Malaysia
  • 4 Medical Governance Research Institute, Minato-ku, Tokyo, Japan; Department of Internal Medicine, Navitas Clinic Kawasaki, Kawasaki, Kanagawa, Japan
  • 5 Medical Governance Research Institute, Minato-ku, Tokyo, Japan; Department of Breast Surgery, Jyoban Hospital of Tokiwa Foundation, Iwaki, Fukushima, Japan
Cancer Cell, 2021 09 13;39(9):1165-1166.
PMID: 34358449 DOI: 10.1016/j.ccell.2021.07.008

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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