Registration of Human Stem Cell-based products ordered

The Food and Drug Administration (FDA) has ordered the registration of human stem cell and cell-based or cellular therapies in the country.

"Pursuant to Administrative Order 2013-0012 known as 'Rules and Regulations Governing the Accreditation of Health Facilities Engaging in Human Stem Cell and Stem-Cell Based or Cellular Therapies in the Philippines' strengthening of the regulatory framework to ensure access to safe and quality health facilities engaging in human stem cell and cell-based or cellular therapies in the Philippines has been promulgated," the FDA said.

It said the circular "does not cover cellular or cell-based therapeutic products intended to replace blood volume or alter the coagulative properties of blood."

The order also does not cover human embryos for research, human embryonic stem cells, aborted human fetal stem cells and plant parts labeled as stem cell as the creation, importation, promotion and marketing of these products are banned in the country.

Stem-cell based products of animal origin are also prohibited from being registered with the FDA.

Under the guidelines, companies have to submit various documents, including the good manufacturing practice certificate of the stem-cell based manufacturer, information of the product and its manufacture and scientific evidence to support each claimed indication, copy of marketing authorization from the national regulatory authority of the exporting country, claimed shelf-life and stability studies, list of countries where the product is already approved and date of approval. (With a report from Jenny F. Manongdo)

Read this article:
Registration of Human Stem Cell-based products ordered

Related Post