Taiwan’s exosome policy shift signals more predictable approval path for cosmetics

The Taiwan Food and Drug Administration (TFDA) has loosened regulatory requirements for exosomes in cosmetics. 

Under the Ministry of Health and Welfare, the country has issued a regulatory document titled “Documentation Requirements for Case-by-Case Applications for the Use of Exosomes Derived from Human Cells in Cosmetics.” The document adjusts restrictions on exosomes, human cells, tissues, and products derived from them — evaluating the ingredients on a case-by-case basis. 

In March 2024, Taiwan made it exceptionally difficult to use human cell-derived exosomes in cosmetics. Companies could only get approval after submitting a large safety and quality data package, and it was made mandatory for every applicant to undergo all long-term tests. 

Now, the TFDA will decide which tests are needed based on product, data, and risk profile. The revised annex took effect immediately upon the document’s publication on February 2.

Exosomes are microscopic messengers, released by skin cells, that contain proteins, lipids, and genetic material. The ingredient helps strengthen communication between skin cells that aging impairs. They are touted as next-generation anti-aging actives that boost cell renewal and collagen production.

Case-by-case evaluations

Despite the updates, Taiwan maintains its position as one of the strictest markets in Asia for human-derived exosomes. The revision does not signal a relaxation of the country’s regulatory position on human-derived cosmetic ingredients. Instead, it reflects a move toward a more proportionate, science-driven assessment of safety data. 

By allowing certain long-term toxicological studies to be evaluated on a case-by-case basis, TFDA recognizes that not all human cell-derived exosomes exhibit the same exposure profile or level of risk, and that a uniform testing approach may not always be needed.Human cell-derived exosomes remain tightly regulated in Taiwan. 

TFDA has clarified that beauty brands should determine the necessity of these tests based on the specific characteristics of the exosomes — such as their physicochemical properties and the outcomes of other safety evaluations. The authority also retains discretion to request additional studies during the review process where it considers them necessary to support a safety determination. 

Core requirements relating to donor qualification, pathogen screening, manufacturing process controls, batch consistency, stability testing, and mandatory local irritation, antigenicity, and genotoxicity testing remain unchanged.

Innovation and regulation 

Strong regulations on cosmetic ingredients are often critiqued for stifling innovation and making it more difficult for smaller companies to come to fruition. 

Personal Care Insights previously spoke with Joshua Zeichner, a US-based board-certified dermatologist, about the tension among innovation, regulation, and consumer trust regarding human-derived ingredients in cosmetics.

“The newest technology to enter the market is exosomes… While there is huge potential, there are also huge unknowns,” he said.

Innova Market Insights data suggests that growing interest in exosomes has driven a 24% CAGR in patent publications over the past five years. 

From an industry perspective, the TFDA’s case-by-case approval remains a high-bar process, requiring extensive technical documentation, robust quality controls, and close engagement with the regulator. However, for companies already pursuing approval, the revised requirements may improve predictability in dossier planning and offer opportunities to reduce development costs where a strong scientific rationale supports a more targeted testing strategy.

Exosomes often behave like biological materials rather than typical cosmetic ingredients. Therefore, Taiwan treated the ingredients more as medical or biotech materials instead of skin care actives. Regulatory scrutiny continues to shape exosome innovation in cosmetics. 

China’s regulatory changes

Last year, China also adjusted its standards for beauty products to help it become a more accessible hub for advanced cosmetic science.

The government announced updates to its cosmetic rules to speed up approvals, raise safety standards, and make the market more accessible for foreign brands, which have been struggling to keep a stable footing in the country.

China’s National Medical Products Administration (NMPA) issued opinions that focused on accelerating cosmetic approvals, stimulating innovation in raw materials, and strengthening safety oversight. The NMPA’s changes will gradually make China’s cosmetics rules more predictable for global companies amid years of reported slowdowns.