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Taiwan: TFDA Requests Comments on Draft "Regulations for Governing Cell and Gene Therapies"

Wednesday, July 26, 2017: In order to encourage the R&D of the cell and gene therapies, the Taiwan Food and Drug Administration (TFDA) published the draft of the "Regulations for Governing Cell and Gene Therapies" and requested comments from the public.

The public has been waiting for the development of cell therapies, gene therapies or tissue engineering products to alleviate the pains of currently incurable diseases. In order to encourage the R&D of the cell and gene therapies, the Taiwan Food and Drug Administration (TFDA) published the draft of the “Regulations for Governing Cell and Gene Therapies” and requested comments from the public. All comments should be submitted within 60 days from the issuance of the Draft on July 25th, 2017.

As medical technology advances, it is necessary to formulate a set of regulations in order to ensure the quality, safety and efficacy of cell and gene products and to further protect patient’s rights of accessing cell and gene therapies.

The TFDA has referred to international regulations and systems to formulate the Draft. The Draft clearly defines cell and gene therapies, regulates the qualification of donors and ensures that products are free from the contamination of infectious diseases. The Draft consists of 15 articles, including a mechanism for issuing a preliminary license to products without safety concerns and relevant penalties.

The Draft is available from the official websites of the TFDA and the MOHW. Any comments on this Draft should reach the TFDA within 60 days.

 
 
 
 
 
 
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