All Stories

  1. Regulatory/Scientific Supports for Micro-, Small-, and Medium-Sized Enterprises (SMEs) With Medicinal Products Provided by the PMDA and EMA

    Article • Therapeutic Innovation & Regulatory Science, May 2018, SAGE Publications

    Hideyuki Kondo

  2. What to Know About Medicines With New Active Ingredients Approved in FY 2016 / 2016 in Japan and EU

    Article • Therapeutic Innovation & Regulatory Science, July 2017, SAGE Publications

    Hideyuki Kondo

  3. A Comparison of PMDA and EMA Consultations for Regulatory and Scientific Matters in Drugs and Regenerative Medicine Products

    Article • Therapeutic Innovation & Regulatory Science, December 2016, SAGE Publications

    Hideyuki Kondo

  4. The Current Status of Sakigake Designation in Japan, PRIME in the European Union, and Breakthrough Therapy Designation in the United States

    Article • Therapeutic Innovation & Regulatory Science, September 2016, SAGE Publications

    Hideyuki Kondo