Clinical Translation of Cell Therapy, Tissue Engineering, and Regenerative Medicine Product in Malaysia and Its Regulatory Policy.
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- Record sourced from PubMed, PMID 26192075.
- Also identified by DOI 10.1089/ten.TEA.2014.0521 and PMC identifier 4684660.
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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.
Medical subject headings
- Biological Products
- Cell- and Tissue-Based Therapy
- Drug Industry
- Regenerative Medicine
- Tissue Engineering