Recently I paid a visit to an online forum about hair loss to find there were lots of buzz about NGF-574H. I was happy to see such an active interest in the product before the official launch. in the meantime, however, I found some of them talk based on the wrong information. Here are some facts and history behind the product:
(1) In 2016, MFDS Korea (Korea FDA) announced that it would expand the scope of functional cosmetics to include hair loss symptom relief claim if the efficacy and safety are proved pursuant to their guideline. Human stem cell conditioned media is already allowed as an ingredient for cosmetic product if manufactured at a qualified facility audited by MFDS.
(2) NGF-574H was originally intended to be developed as a drug for alopecia at Medipost. As you may already be aware, it is long and very costly process to develop a drug. Though functional cosmetics may have much limited regulatory freedom to claim the efficacy (for example we may not claim hair growth), it would still make sense as we could introduce the product to the market much faster.
(3) We have submitted application for NGF-574H to register as a functional cosmetics to MFDS. The regulatory review is taking much longer than expected because we assume, If registered, it would be the first functional cosmetic product in Korea with stem cell conditioned media as an active ingredient. The regulatory review is still ongoing. We expect the registration before the end of this year but who knows?
(4) Off label usage of the product is allowed to medical doctors in Korea. They can use and recommend to patients whatever product they believe effective on specific indication regardless of registered label. Dermatologists are eager for the innovative hair growth products proved by legitimate clinical trials as they are disappointed with solutions available in the market. We discussed with some KOL dermatologists here and decided we would launch the product through clinics and hospitals exclusively before registration as a functional cosmetics.
(5) The three products we are going to launch in Korea shortly are not intended to sell as a package. Daily use of hair tonic alone will help your thinning and losing hair as proved in the clinical trials with male and female subjects. For those who are not satisfied with hair loss shampoo in the market, doctors may recommend our shampoo. We will also launch booster product in Korea exclusive for hair treatment in clinic coupled with dermatology devices, based on the strong request by the KOL dermatologists. The product will be used only by medical professionals for patient treatment depending on their hair status.
(6) There are many inquiries about the product availability oversea through our website. Not concluded yet, but we consider establishing a website for oversea patients where they would order the product online if it were in line with regulatory compliance.
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