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

Ruszymah Idrus, Arpah Abas, Fazillahnor Ab Rahim, Aminuddin Bin Saim

Research output: Contribution to journalArticle

4 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)2812-2816
Number of pages5
JournalTissue Engineering - Part A
Volume21
Issue number23-24
DOIs
Publication statusPublished - 1 Dec 2015

Fingerprint

Regenerative Medicine
Malaysia
Tissue Engineering
Cell- and Tissue-Based Therapy
Tissue engineering
Tissue
Drug products
Cells
Health
Gene therapy
Accreditation
Stem cells
Pharmaceutical Preparations
Guidelines
Stem Cell Research
Genetic Therapy
Research Personnel
Clinical Trials

ASJC Scopus subject areas

  • Bioengineering
  • Biochemistry
  • Biomaterials
  • Biomedical Engineering

Cite this

Clinical Translation of Cell Therapy, Tissue Engineering, and Regenerative Medicine Product in Malaysia and Its Regulatory Policy. / Idrus, Ruszymah; Abas, Arpah; Ab Rahim, Fazillahnor; Saim, Aminuddin Bin.

In: Tissue Engineering - Part A, Vol. 21, No. 23-24, 01.12.2015, p. 2812-2816.

Research output: Contribution to journalArticle

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