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Regulatory Oversight of Cell- and Tissue-Based Therapeutic Products and Gene Therapy Products in Singapore.
Adv Exp Med Biol. 2015; 871:195-212.AE

Abstract

The regulatory environment for cell- and tissue-based therapeutic products and gene therapy products is rapidly evolving and drug regulatory agencies are working towards establishing a risk-based system in the regulatory framework. Similarly in Singapore, a risk-based tiered approach has been applied whereby clinical trials and product licence of high-risk cell- and tissue-based therapeutic products (substantially manipulated products, products intended for nonhomologous use or combined products) and gene therapy products are regulated as medicinal products under the Medicines Act. There is no legal definition for cell- and tissue-based therapeutic and gene therapy products. The current working definition for a cell- and tissue-based therapeutic product is an article containing or consisting of an autologous or allogeneic human cell or tissue that are used for or administered to, or intended to be used for or administered to, human beings for the diagnosis, treatment, or prevention of human diseases or conditions. Gene therapy products are included under the current biological medicinal product definition.

Authors+Show Affiliations

Audits Branch, Audit and Licensing Division, Health Products Regulation Group, Health Sciences Authority, 150 Cantonment Road, Cantonment Centre, Blk A, #01-02, Singapore, 089762, Singapore. GOH_Choon_Wee@hsa.gov.sg.Advanced Therapy Products Unit, Premarketing, Health Products Regulation Group, Health Sciences Authority, 11 Biopolis Way, Helios, #11-01, Singapore, 138667, Singapore. kellathur_srinivasan@hsa.gov.sg.Advanced Therapy Products Unit, Premarketing, Health Products Regulation Group, Health Sciences Authority, 11 Biopolis Way, Helios, #11-01, Singapore, 138667, Singapore. ONG_Lee_Lee@hsa.gov.sg.Clinical Trials Branch, Premarketing, Health Products Regulation Group, Health Sciences Authority, 11 Biopolis Way, Helios, #11-01, Singapore, 138667, Singapore. WU_Xiaofeng@hsa.gov.sg.

Pub Type(s)

Journal Article
Review

Language

eng

PubMed ID

26374220

Citation

Goh, Choon Wee, et al. "Regulatory Oversight of Cell- and Tissue-Based Therapeutic Products and Gene Therapy Products in Singapore." Advances in Experimental Medicine and Biology, vol. 871, 2015, pp. 195-212.
Goh CW, Kellathur SN, Ong LL, et al. Regulatory Oversight of Cell- and Tissue-Based Therapeutic Products and Gene Therapy Products in Singapore. Adv Exp Med Biol. 2015;871:195-212.
Goh, C. W., Kellathur, S. N., Ong, L. L., & Wu, X. (2015). Regulatory Oversight of Cell- and Tissue-Based Therapeutic Products and Gene Therapy Products in Singapore. Advances in Experimental Medicine and Biology, 871, 195-212. https://doi.org/10.1007/978-3-319-18618-4_11
Goh CW, et al. Regulatory Oversight of Cell- and Tissue-Based Therapeutic Products and Gene Therapy Products in Singapore. Adv Exp Med Biol. 2015;871:195-212. PubMed PMID: 26374220.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Regulatory Oversight of Cell- and Tissue-Based Therapeutic Products and Gene Therapy Products in Singapore. AU - Goh,Choon Wee, AU - Kellathur,Srinivasan N, AU - Ong,Lee Lee, AU - Wu,Xiaofeng, PY - 2015/9/17/entrez PY - 2015/9/17/pubmed PY - 2015/12/30/medline KW - Cell- and tissue-based therapeutic product KW - Clinical trial certificate KW - Gene therapy product KW - Good manufacturing practice KW - Product licence SP - 195 EP - 212 JF - Advances in experimental medicine and biology JO - Adv. Exp. Med. Biol. VL - 871 N2 - The regulatory environment for cell- and tissue-based therapeutic products and gene therapy products is rapidly evolving and drug regulatory agencies are working towards establishing a risk-based system in the regulatory framework. Similarly in Singapore, a risk-based tiered approach has been applied whereby clinical trials and product licence of high-risk cell- and tissue-based therapeutic products (substantially manipulated products, products intended for nonhomologous use or combined products) and gene therapy products are regulated as medicinal products under the Medicines Act. There is no legal definition for cell- and tissue-based therapeutic and gene therapy products. The current working definition for a cell- and tissue-based therapeutic product is an article containing or consisting of an autologous or allogeneic human cell or tissue that are used for or administered to, or intended to be used for or administered to, human beings for the diagnosis, treatment, or prevention of human diseases or conditions. Gene therapy products are included under the current biological medicinal product definition. SN - 0065-2598 UR - https://www.unboundmedicine.com/medline/citation/26374220/Regulatory_Oversight_of_Cell__and_Tissue_Based_Therapeutic_Products_and_Gene_Therapy_Products_in_Singapore_ L2 - https://dx.doi.org/10.1007/978-3-319-18618-4_11 DB - PRIME DP - Unbound Medicine ER -