We’re proud to announce a major milestone!
bitop Ectoin® natural Approved
as a Quasi-Drug in Japan!
We’re proud to announce a major milestone:
bitop Ectoin® natural has been officially approved as a quasi-drug by the Japanese Ministry of Health, Labour and Welfare (MHLW)!
What This Means
Quasi-drug (医薬部外品) status in Japan is highly regulated and reserved for ingredients with clinically proven health benefits, such as skin protection, hydration, or prevention of conditions like inflammation or irritation.
This approval confirms that Ectoin® natural meets Japan’s stringent standards for quality, safety, and efficacy.
Why This Matters
Achieving quasi-drug registration in Japan is no small feat.
It involves:
Extensive toxicological and clinical data
Clear proof of functional claims
Full regulatory review and compliance
bitop’s Ectoin® natural has successfully met all these requirements, underscoring its position as a science-backed, multifunctional active with wide-ranging dermatological benefits.
Ectoin® natural – Trusted Worldwide
From barrier repair to anti-inflammatory action, from hydration to pollution defense, Ectoin® natural has proven itself across markets and clinical settings.
With this new regulatory recognition, we are excited to expand our support for preventive skin health and sensitive skin care in the Japanese market.
