Stem cell rules clear, adequate, says FDA

Manila, Philippines The Food and Drug Administration (FDA) said on October 14, its guidelines governing stem cell therapy in the country are adequate and clear, including the registration of products, health facilities and ethics review.

The FDA said 51 health facilities have submitted applications for stem cell therapy treatment, while 14 stem cell product applications have been received as of last month.

The results of the review of these applications are not yet released and the FDA said the exact timetable is still not decided.

The FDA said regulations on stem cell therapy are handled by different agencies for check and balance.

It said health facilities that handle human cells, tissues, and cellular and tissue-based products (HCT/Ps) will be accredited by the Bureau of Health Facilities and Services under the Department of Health (DOH).

Stand-alone clinics should be affiliated with a research medical center that is accredited by the DOH.

Stem cell products should be registered with the FDA to ensure that these products meet safety, efficacy, and quality standard based the product claims.

Ethics review of health research involving human participants is handled by hospital ethics review boards that are registered, accredited and audited by the Philippine Health Research Ethics Board (PHREB).

The FDA added that there is a feedback mechanism and safety monitoring for patients. Patients can report to the FDA any adverse reaction from stem cell products.

Critics said patients should not pay for the cost of clinical trials of drugs since their efficacy and safety are still not proven.

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Stem cell rules clear, adequate, says FDA

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