title: Clinical Translation of Cell Therapy, Tissue Engineering, and Regenerative Medicine Product in Malaysia and Its Regulatory Policy.
abstract: With the worldwide growth of cell and tissue therapy (CTT) in treating diseases, the need of a standardized regulatory policy is of paramount concern. Research in CTT in Malaysia has reached stages of clinical trials and commercialization. In Malaysia, the regulation of CTT is under the purview of the National Pharmaceutical Control Bureau (NPCB), Ministry of Health (MOH). NPCB is given the task of regulating CTT, under a new Cell and Gene Therapy Products framework, and the guidelines are currently being formulated. Apart from the laboratory accreditation, researchers are advised to follow Guidelines for Stem Cell Research and Therapy from the Medical Development Division, MOH, published in 2009.
authors.affiliation: 1 Tissue Engineering Centre, Faculty of Medicine, Universiti Kebangsaan Malaysia Medical Centre , Cheras, Kuala Lumpur, Malaysia .|2 Department of Physiology, Faculty of Medicine, Universiti Kebangsaan Malaysia Medical Centre , Cheras, Kuala Lumpur, Malaysia .
authors.forename: Ruszymah
authors.initials: R
authors.lastname: Bt Hj Idrus
authors.affiliation: 3 Product Registration Centre , National Pharmaceutical Control Bureau, Ministry of Health Malaysia, Petaling Jaya, Selangor, Malaysia .
authors.forename: Arpah
authors.initials: A
authors.lastname: Abas
authors.affiliation: 4 Center for Compliance & Licensing , National Pharmaceutical Control Bureau, Ministry of Health Malaysia, Petaling Jaya, Selangor, Malaysia .
authors.forename: Fazillahnor
authors.initials: F
authors.lastname: Ab Rahim
authors.affiliation: 1 Tissue Engineering Centre, Faculty of Medicine, Universiti Kebangsaan Malaysia Medical Centre , Cheras, Kuala Lumpur, Malaysia .|5 Ampang Puteri Specialist Hospital , Taman Dato' Ahmad Razali, Ampang, Selangor, Malaysia .
authors.forename: Aminuddin Bin
authors.initials: AB
authors.lastname: Saim
mesh_terms: D000818:Animals; D001688:Biological Products / Q000592:standards* / Q000627:therapeutic use; D064987:Cell- and Tissue-Based Therapy / Q000592:standards*; D004345:Drug Industry / Q000331:legislation & jurisprudence / Q000592:standards; D006801:Humans; D008296:Malaysia; D044968:Regenerative Medicine / Q000331:legislation & jurisprudence / Q000592:standards; D023822:Tissue Engineering / Q000331:legislation & jurisprudence / Q000592:standards
chemical_list: D001688:Biological Products