Ensuring Compliance: A Guide to Japan’s Quasi-drug Regulations

Background

QUASI-DRUG topicals in Japan fall between cosmetics and pharmaceuticals, with a wide range of vague concepts and classifications, and the regulations and compliance requirements for QUASI-DRUG topicals are also complex. In recent years, incidents such as mass skin inflammation caused by skin lightening products, adjustments in labeling and efficacy requirements for QUASI-DRUG products, and stricter scrutiny of ingredients have required companies to make timely strategic adjustments to ensure sustainability and competitiveness.

To help cosmetic companies address these challenges, ChemLinked is hosting an exclusive webinar titled “Ensuring Compliance: A Guide to Japan’s Quasi-drug Regulations.” By attending this seminar, participants will be able to gain an in-depth understanding of the Japanese cosmetic regulatory system, product registration procedures for QUASI-DRUG, product compliance points, and labeling considerations for QUASI-DRUG.

In this webinar, Chemlinked has invited Mr. Yuan Tiangu, a professional regulatory expert and market analyst, to discuss the core compliance issues of Japan’s QUASI-DRUG products through fascinating case studies and practical applications. Experts from ChemLinked will offer the same content in Chinese to cater to attendees from different language backgrounds. Through this webinar, we will share with you the latest regulatory requirements, innovative compliance strategies and emerging market trends, and provide you with practical solutions to help you better understand and address compliance challenges.

Reference links:

Notes:

Please feel free to send us questions before, during or after the webinar;

The webinar livestreaming is freely available to all users. You are welcome to register for and participate in the webinar.

Kindly be aware that the access to the slides, recording, and Q&A collection is limited to ChemLinked premium members only [Upgrade now].

History of Cosmetic Regulations in Japan

Outline of Cosmetics Regulations in Japan’s QUASI-DRUG Products Division

Classification of QUASI-DRUG Products and Cosmeceuticals

Qualifications Required for Registration of Foreign QUASI-DRUG Manufacturing/sales Regulation

GQP and GVP Systems for Foreign Pharmaceutical Products

Registration of Foreign QUASI-DRUG Manufacturers

Registration of Manufacturing and Sales of Foreign QUASI-DRUG Products

Instructions for Making a Registration File for QUASI-DRUG Registration

Schedule

Date	Time (GMT+8)	World Clock	Language
2024-11-14	22:00 ~ 23:00	London: 14:00-15:00 New York: 09:00-10:00	English
2024-11-27	14:00 ~ 15:00	Japan/South Korea: 15:00-16:00	Chinese

Speaker

Tiangu Yuan

He has 12 years of experience in domestic and international sales of cosmetics and health foods for two major cosmetic groups in Japan, KOSE and POLA & ORBIS. Since the business covers multiple channels such as door-to-door sales, drugstores, online channels, duty free, etc. in Japan, he is familiar with the delicate differences between channels, has rich experience in multi-channel mixed sales, and is familiar with the business environment and market information of the beauty industry in Japan. As an overseas sales executive, he is familiar with the regulatory requirements for cosmetic products in Japan, China (including Taiwan), South Korea, Thailand, Vietnam, and Europe, as well as the compliance requirements related to health food registration and filing.