In Malaysia, multiple authorities are responsible for the oversight and regulation of cellular therapy products. The Ministry of Health Malaysia is the umbrella authority responsible for developing and implementing laws and guidelines to ensure the health of Malaysians and to provide the best access to quality health. The Ministry of Health Malaysia has published guidelines for stem cell research and therapy. For example, with regard to the research of stem cells, the Ministry of Health requires that a clinical study be reviewed by an Institutional Review Board or ethics committee and that research be conducted based on sound scientific principles, and limits the use of specific cells for research purposes. For stem cell therapies, the Ministry of Health Malaysia recognizes that the most mature form of stem cell therapy is transplanation of hematopoietic progenitor cells sourced from umbilical cord blood and has published national guidelines specifically for hematopoietic stem cell therapy. Additionally, it is required that facilities performing these activities be licensed under appropriate regulations, and it is recommended that these facilities undergo internal and external quality audits. The guidelines also limit the uses and types of cells that can be used for a therapeutic effect.
The National Pharmaceutical Control Bureau (NPCB) also is responsible for regulating cellular therapy products including clinical trials of products under its jurisdiction. For cellular therapy products that are regulated as biological pharmaceutical products (also referred to as cellular and genetic therapy products), the NPCB requires that are such products be approved before they can be sold in Malaysia. However, before the products can be sold, they must be evaluated from safety, efficacy, and quality perspectives. The facilities that process and manufacture cells and tissues regulated as biological products are also subject to current good manufacturing practice regulations.
Links to regulatory authority’s websites and external resources are in the Related Information box.
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