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. 2015 Dec;21(23-24):2812-6.
doi: 10.1089/ten.TEA.2014.0521. Epub 2015 Aug 21.

Clinical Translation of Cell Therapy, Tissue Engineering, and Regenerative Medicine Product in Malaysia and Its Regulatory Policy

Ruszymah Bt Hj Idrus  1   2 , Arpah Abas  3 , Fazillahnor Ab Rahim  4 , Aminuddin Bin Saim  1   5
Affiliations

Clinical Translation of Cell Therapy, Tissue Engineering, and Regenerative Medicine Product in Malaysia and Its Regulatory Policy

Ruszymah Bt Hj Idrus et al. Tissue Eng Part A. 2015 Dec.

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.

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Figures

<b>FIG. 1.</b>
FIG. 1.
Summary of the pathways in construction of a Good Manufacturing Practice (GMP)-certified laboratory in Malaysia and the close relationship with research and development facilities.
<b>FIG. 2.</b>
FIG. 2.
Overview of the process of a tissue engineering product and its quality control inspection.
<b>FIG. 3.</b>
FIG. 3.
Regular training and inspection is important in maintaining the quality and reducing incidence. It can be divided into training the human resource and monitoring the environment and instruments.
See this image and copyright information in PMC

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References

    1. Mason C., McCall M.J., Culme-Seymour E.J., Suthasan S., Edwards-Parton S., Bonfiglio G.A., and Reeve B.C. The global cell therapy industry continues to rise during the second and third quarters of 2012. Cell Stem Cell 11, 735, 2012 - PubMed
    1. Martin I., Baldomero H., Bocelli-Tyndall C., Passweg J., Saris D., and Tyndall A. The survey on cellular and engineered tissue therapies in Europe in 2010. Tissue Eng Part A 18, 2268, 2012 - PubMed
    1. Hellman K.B. Biomedical applications of tissue engineering technology: regulatory issues. Tissue Eng 1, 203, 1995 - PubMed
    1. Brévignon-Dodin L. Regulatory enablers and regulatory challenges for the development of tissue-engineered products in the EU. Biomed Mater Eng 20, 121, 2010 - PubMed
    1. Caunday O., Bensoussan D., Decot V., Bordigoni P., and Stoltz J.F. Regulatory aspects of cellular therapy product in Europe: JACIE accreditation in a processing facility. Biomed Mater Eng 19, 373, 2009 - PubMed

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