In order to ensure the quality, safety and effectiveness of regenerative medicine and to protect patient’s right, the Executive Yuan passed two drafts of regulations on regenerative medicine proposed by the MOHW.  The two proposals, which are titled “The Regenerative Medicine Act” and “The Regulations Governing Regenerative Medicinal Products”, will then be forwarded to the Legislative Yuan for legislative review. 

Premier Chen Chien-Jen expressed that the global pandemic has highlighted the importance of the biomedical industry and has confirmed the strategic role of the biotechnology and healthcare in national security.    In 2020, President Tsai announced to list the precision medicine industry as one of the country’s six core strategic industries; and the development of regenerative medicine is part of the key focus.

According to Premier Chen, as the biotechnology continues to advance, the regulatory capacity concerning regenerative medicine is becoming more and more mature.  The legislation of these two drafts will contribute to the innovation and the promotion of the regenerative medicine industry, accelerate the clinical applications of research results and reduce the gap between industrial development and regulatory management.   These regulations are crucial in ensuring the quality, safety and effectiveness of regenerative medicine, and in protecting patient’s rights.   Premier Chen has already instructed the MOHW to actively communicate with the legislators so as to complete the legislation process as quickly as possible.

【2023-02-16/ Executive Yuan】