Thu, Nov 08, 2018 - Page 3 News List

Concern over regenerative medicinal product rules

By Lee I-chia  /  Staff reporter

The Food and Drug Administration (FDA) would take healthcare practitioners’ concerns into consideration when drafting the regulations on regenerative medicinal products, FDA Director-General Wu Shou-mei (吳秀梅) said yesterday.

The Executive Yuan on Oct. 18 approved a draft act for regulating regenerative medicinal products and the bill has been submitted to the Legislative Yuan for further approval.

Referencing the related regulations in Japan, the draft act aims to speed up the conditional approval of certain types of regenerative medicinal products, including cell therapies, gene therapy and tissue engineering that are mainly for the treatment of cancers.

While passing the draft act is expected to generate huge market value and industrial growth, doctors and legislators yesterday held a public hearing at the legislature, at which they voiced their concerns about the regulations.

Chang Bin-jui (張濱叡), deputy executive director of the Taiwan Medical Association’s Medical Law Think Tank, said most of the articles in the draft act are similar to the articles in the Medical Act (醫療法) and the Pharmaceutical Affairs Act (藥事法), and an article about allowing critically ill patients to be treated with regenerative medicine that is still under clinical trial seems to be similar to a provision for compassionate use.

The association is concerned about the vagueness of the draft act, Chang said, urging the Ministry of Health and Welfare to clarify the details, including regulations on the import, manufacture and registration of regenerative medicinal products, as well as the donation of biological ingredients or liability for adverse drug reactions.

The FDA plans to draft regulations relating to the draft act and it would take doctors’ concerns into consideration, Wu said.

Further public hearings would be held once the regulations have been drafted, as well as a 60-day comment period before they go into effect, he said.

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