Flexible and Expedited Regulatory Review Processes for Innovative Medicines and Regenerative Medical Products in the US, the EU, and Japan

International Journal of Molecular Sciences
Sumimasa Nagai

Abstract

Several expedited regulatory review projects for innovative drugs and regenerative medical products have been developed in the US, the EU, and Japan. Each regulatory agency has elaborated an original regulatory framework and adopted regulatory projects developed by the other regulatory agencies. For example, the Food and Drug Administration (FDA) first developed the breakthrough therapy designation, and then the Pharmaceuticals and Medical Devices Agency (PMDA) and European Medicines Agency (EMA) introduced the Sakigake designation and the priority medicines (PRIME) designation, respectively. In addition, the necessity of the product being first development in Japan is the original feature of the Sakigake designation, while actively supporting the development of advanced-therapy medicinal products (AMTPs) by academia or small/medium-sized sponsors is the original feature of the PRIME; these particular features are different from the breakthrough therapy designation in the US. In this review article, flexible and expedited review processes for new drugs, and cell and gene therapies in the US, the EU, and Japan are described. Moreover, all the drugs and regenerative medical products that were granted conditional approval or Sakig...Continue Reading

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Citations

Jan 8, 2020·Clinical and Translational Science·Erica M CoxAishwarya Shankar
Feb 18, 2020·Expert Review of Molecular Diagnostics·Rumiko Shimazawa, Masayuki Ikeda
Mar 1, 2020·Journal of Artificial Organs : the Official Journal of the Japanese Society for Artificial Organs·Nobuhiro HandaHiroyuki Arai
Jul 9, 2020·Haemophilia : the Official Journal of the World Federation of Hemophilia·Ulrike M ReissTsukasa Ohmori
Jan 19, 2021·MAbs·Hélène Kaplon, Janice M Reichert
Dec 4, 2020·Science Translational Medicine·James P K ArmstrongMolly M Stevens
Feb 25, 2021·Regenerative Medicine·Satsuki YamadaAndre Terzic
Mar 12, 2021·British Journal of Clinical Pharmacology·Mototsugu TanakaMutsuhiro Ikuma
Aug 10, 2021·Frontiers in Bioengineering and Biotechnology·Alan Raybould
Aug 27, 2021·Journal of Market Access & Health Policy·R LawlorA Roediger
Nov 2, 2021·Stem Cells Translational Medicine·Haidan Chen

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Software Mentioned

Collategen
PRIME
RMAT

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