Regulations in the field of quasi-drugs and cosmetics have followed a completely different process. With the establishment of the Pharmaceutical Affairs Law in 1960, the regulatory system for quasi-drugs and cosmetics was united. Since then, the introduction of all ingredients, new cosmetic standards, etc. has been carried out. Consumer interest in quasi-drugs and cosmetics has become increasingly greater, driven by the recent increase in health awareness. In addition, for quasi-drugs and cosmetics, both inbound and outbound demand in the market is strong, and international distribution is progressing. Under these circumstances, the supply of high-quality and safe products is further demanded. In order to ensure the quality of ingredients blended in quasi-drugs and cosmetics and the safety of products, the Japanese government is reviewing the regulations as needed. This article outlines the transition of regulations in the field of quasi-drugs and cosmetics, with specific examples.
マテリアル事業部ではPLGA（乳酸・グリコール酸共重合体）を用いた, 独自のナノ粒子複合化技術を活用した事業に取り組んでいます。製薬・美容科学研究センターでは受託研究及び化粧品・医薬部外品開発を行っています。五條工場では2016年に発売したナノインパクト100を始めとする自社ブランドの育毛剤や化粧品の製品製造のほか, PLGAナノ粒子を配合した美白パウダーなどの数多くのOEM化粧品の製造を行っています。
The market scale of hair growth stimulants including medicines and quasi-drugs in Japan was 67.5 billion yen at 2016. It is expected that the market of hair growth stimulant for women will be bigger in future. Therefore, the market needs to develop new hair growth stimulants. Nowadays, it is difficult to develop novel medicines or novel quasi-drugs for hair growth, because the wave of animal experiment abolition is getting bigger in the world-wide cosmetics industry. Under such circumstances, despite authorities approving over 30 active quasi-drugs in the field of hair tonic products, most of these drugs are not fully utilized. It will be important that we reevaluate these approved active ingredients. And, the importance of digging out the approved quasi-drugs is expected to increase in the future. In this lecture, I would like to describe a reassessment of approved active quasi-drugs for hair growth and its evaluation methods.
Recently there were typical reports about the serious side-effect syndromes for the medicated cosmetics in Japan. One side-effect symptom was due to medicated soap with the hydrolyzed wheat powder so-called as “Cha No Sizuku Sekken.” This symptom was called as the food-dependent exercise-induced anaphylaxis (FDEIA). Another side-effect symptom was caused to rododendrol (4-(4-hydroxyphenyl)-2-bunanol, HPBol) as the whitening agent. HPBol happened the serious side-effect of vitiligo against many users. In this report, I explain to describe the position of quasi drugs in Japan and to make clear to both the distribution of molecular weight about the hydrolyzed wheat powder described by Dr. Yoshiaki Ikarashi and the cause of giving the side-effect of rododendrol described by Takumi Akiyama.
Cosmetics and medicated cosmetics are recognized as a necessity of daily life to increase the quality of life, and are used to maintain health and increase beauty. Cosmetics and medicated cosmetics are mainly regulated by The Law on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical devices. The main purpose of the Law is to improve public health, and to achieve this, securement of the quality, efficacy, and safety of cosmetics etc. is required. To fulfill the purpose, it is necessary to understand the regulation for cosmetics and medicated cosmetics accurately and to follow the Law properly. In this report, the definition of cosmetics and medicated cosmetics, regulations on ingredients and efficacy-effects, and regulations for selling cosmetics etc. are described.