StemCell Therapy

In brief

From 6 to 27 November 2020, the Health Sciences Authority (HSA) will be carrying out a public consultation seeking feedback on the proposed Health Products Act ("Amendment of First Schedule") Order 2020 ("HPA Amendment Order"), and the proposed Health Products (Cell Tissue and Gene Therapy Products) Regulations 2020 ("CTGTP Regulations") (collectively, the "Proposed Regulations"), which seek to regulate cell, tissue and gene therapy products (CTGTP). The Proposed Regulations seek to flesh out (i) a definition of CTGTP, (ii) a risk-based regulatory approach for CTGTPs, and (iii) introduce requirements unique to CTGTP.

Comments

CTGTP are a notably emerging and cutting edge field of medicine, providing great potential for the development of new treatment opportunities. Apart from being able to engineer the growth of healthy and functional tissues to reconstruct, regenerate or repairdamaged tissues or organs, CTGTP may also be used in therapies to treat or cure disease through the modification of individual genes.

The HSA has noted that the CTGTP regulations are reportedly intended to facilitate patient access to therapies that meet appropriate safety, efficacy and quality standards, and to provide a fit-for-purpose regulatory framework to support product development and facilitate product commercialisation. Given the novelty of this legislation, it may be beneficial for businesses to participate in the public consultation given their expertise and experience in this area of medicine. This could also assist toensure that any eventual laws appropriately account for the unique nature of CTGTP while not being excessively onerous on suppliers, importers, and manufacturers.

In more detail

From 6 to 27 November 2020, the Health Sciences Authority (HSA) will be carrying out a public consultation seeking feedback on the proposed Health Products Act ("Amendment of First Schedule") Order 2020 ("HPA Amendment Order"), and the proposed Health Products (Cell Tissue and Gene Therapy Products) Regulations 2020 ("CTGTP Regulations") (collectively, the "Proposed Regulations"), which seek to regulate cell, tissue and gene therapy products (CTGTP) as a new category of health products. The Proposed Regulations are intended to provide (i) a definition of CTGTP, (ii) a risk-based regulatory approach for CTGTPs, and (iii) introduce requirements unique to CTGTP.

Part (i) will be addressed via the HPA Amendment Order, which seeks to insert the following definition of CTGTP under the Health Products Act: "a substance consisting of human cells or tissues that are either autologous obtained from the same individual) or allogeneic (obtained from another individual), viable animal cells or tissues, or recombinant nucleic acids (i.e. modified DNA or RNA as carriers of a therapeutic gene); that is intended for diagnosis, treatment or prevention of any human disease or medical condition".

The CTGTP Regulations in turn, addressparts (ii) and (iii). The proposed regulatory framework is generally split into the following areas:

The draft HPA Amendment Order and CTGTP Regulations can be foundhereandhere. Feedback on the regulations may be providedhere.

See the original post:
Singapore: Public consultation on Proposed Regulations of Cell, Tissue and Gene Therapy Products - Lexology

This entry was posted on November 24, 2020 at 9:53 am and is filed under Gene therapy. You can follow any responses to this entry through the RSS 2.0 feed. Both comments and pings are currently closed. |