title: Report of the international conference on regulatory endeavors towards the sound development of human cell therapy products.
abstract: The regulation of human cell therapy products is a key factor in their development and use to treat human diseases. In that regard, there is a recognized need for a global effort to develop a set of common principles that may serve to facilitate a convergence of regulatory approaches to ensure the smooth and efficient evaluation of products. This conference, with experts from regulatory agencies, industry, and academia, contributed to the process of developing such a document. Elements that could form a minimum consensus package of requirements for evaluating human cell therapy products were the overall focus of the conference. The important regulatory considerations that are unique to human cell therapy products were highlighted. Sessions addressed specific points that are different from those of traditional biological/biotechnological protein products. Panel discussions complemented the presentations. The conference concluded that most of the current regulatory framework is appropriate for cell therapy, but there are some areas where the application of the requirements for traditional biologicals is inappropriate. In addition, it was agreed that there is a need for international consensus on core regulatory elements, and that one of the major international organizations should take the lead in formulating such a consensus document.
authors: Kindai University, Japan.
authors: Takao
authors: T
authors: Hayakawa
authors: Kobe University, Japan.
authors: Takashi
authors: T
authors: Aoi
authors: Advanced Biologicals, UK.
authors: Christopher
authors: C
authors: Bravery
authors: Novartis Pharmaceuticals, Switzerland.
authors: Karin
authors: K
authors: Hoogendoorn
authors: World Health Organization (WHO), Switzerland.
authors: Ivana
authors: I
authors: Knezevic
authors: Japan Pharmaceutical Manufacturers Association (JPMA), Japan.
authors: Junichi
authors: J
authors: Koga
authors: Pharmaceuticals and Medical Devices Agency (PMDA), Japan.
authors: Daisuke
authors: D
authors: Maeda
authors: National Institute of Biomedical Innovation (NIBIO), Japan.
authors: Akifumi
authors: A
authors: Matsuyama
authors: Medicines and Healthcare Products Regulatory Agency (MHRA), UK.
authors: James
authors: J
authors: McBlane
authors: Tokyo Medical and Dental University, Japan.
authors: Tomohiro
authors: T
authors: Morio
authors: International Alliance for Biological Standardization, (IABS), Switzerland. Electronic address: petriccianiIABS@aol.com.
authors: John
authors: J
authors: Petricciani
authors: New York Stem Cell Foundation, USA.
authors: Mahendra
authors: M
authors: Rao
authors: Health Canada, Canada.
authors: Anthony
authors: A
authors: Ridgway
authors: Pharmaceuticals and Medical Devices Agency (PMDA), Japan.
authors: Daisaku
authors: D
authors: Sato
authors: National Institute of Health Sciences (NIHS), Japan.
authors: Yoji
authors: Y
authors: Sato
authors: National Institute of Biological Standards and Control (NIBSC), UK.
authors: Glyn
authors: G
authors: Stacey
authors: Pharmaceuticals and Medical Devices Agency (PMDA), Japan.
authors: Norihisa
authors: N
authors: Sakamoto
authors: University Paris Descartes, France.
authors: Jean-Hugues
authors: JH
authors: Trouvin
authors: National Institute for Child Health and Development (NICHD), Japan.
authors: Akihiro
authors: A
authors: Umezawa
authors: Tokyo Women's Medical University, Japan.
authors: Masayuki
authors: M
authors: Yamato
authors: Tokyo Women's Medical University, Japan.
authors: Kazuo
authors: K
authors: Yano
authors: Chemo-Sero Therapeutic Institute, Japan.
authors: Hiroyuki
authors: H
authors: Yokote
authors: Japan Pharmaceutical Manufacturers Association (JPMA), Japan.
authors: Kentaro
authors: K
authors: Yoshimatsu
authors: Pharma Biotechnology, France.
authors: Pierrette
authors: P
authors: Zorzi-Morre
mesh_terms: D001688:Biological Products; D001709:Biotechnology / Q000331:legislation & jurisprudence*; D064987:Cell- and Tissue-Based Therapy; D006801:Humans
chemical_list: D001688:Biological Products
keywords: Stem cells; Therapy; Transplantation