Introduction
Entering Japan's prestigious beauty market is a major opportunity for overseas brands. However, navigating Japan's unique regulatory landscape is the fundamental key to success. In Japan, full regulatory compliance requires correct product classification, licensing, ingredient conformity, mandatory notifications, product registration for quasi-drugs, post-marketing obligations, and strict control of claims and advertising.
This guide provides essential information on complying with Japan's Pharmaceuticals and Medical Devices Act (PMD Act) for cosmetics and quasi-drugs.
Understanding Japan's Regulatory Framework - PMD Act
In Japan, cosmetics are governed by the Pharmaceuticals and Medical Devices Act, which was formerly known as the Pharmaceutical Affairs Law. Products are classified into two categories: Cosmetics and Quasi-Drugs.
The regulations governing each category differ greatly. Misclassifying your product or failing to meet compliance standards can lead to significant delays, financial penalties, or removal from the market.
The Critical Difference: Cosmetics vs. Quasi-Drugs
The first and most critical step for overseas brands is distinguishing between cosmetics and quasi-drugs. The two categories have entirely different regulatory paths, and misclassification is a top cause of market entry failures.
What Is a "Cosmetic" in Japan?
According to the PMD Act, cosmetics are defined as:
“Articles with mild action on the human body, which are intended to be applied to the human body through rubbing, sprinkling or other methods, aiming to clean, beautify and increase the attractiveness, alter the appearance or to keep the skin or hair in good condition.”
Typical cosmetic categories include:
Perfume and eau de cologne
Makeup cosmetics (e.g. foundation, lipsticks, eyeshadows)
Skincare products (e.g. moisturizers, lotions)
Hair care products (e.g. shampoos, conditioners)
Special purpose cosmetic(e.g. Sunscreen, shaving cream and others)
Cosmetic soaps
※ Cosmetics must not claim any therapeutic or functional effects related to treatment or physiological improvement.
What Is a "Quasi-Drug" in Japan?
Quasi-drugs occupy a middle ground between cosmetics and pharmaceuticals. They are defined as: “Products with mild action on the human body, they are considered as cosmetics with mild pharmacological action.”
Typical Quasi-Drug categories include:
Whitening products (to suppress melanin production), acne treatments, anti-prickly-heat products
Anti-dandruff and anti-itching shampoos
Hair growth or anti-hair-loss products
Deodorants for suppressing body or perspiration odor
Fluoride-containing toothpastes
Regulatory Requirements For Imported Cosmetics in Japan
Obtain the Cosmetic Manufacturing and Marketing License: Companies must obtain the corresponding license before they can conduct manufacturing or marketing activities for cosmetics in Japan.
Ingredient Compliance: All ingredients must comply with Japan's Standards for Cosmetics issued by the Ministry of Health, Labour and Welfare (MHLW)
Submit the Cosmetic Notification: Foreign manufacturers/importers must submit both a notification and a marketing notification to the regulatory officials, whereas domestic manufacturers are only required to submit a cosmetic marketing notification.
Claims & Advertising Compliance: All marketing claims must adhere to PMD Act guidelines and cannot cross into quasi-drug or drug territory.
Regulatory Requirements For Imported Quasi-Drugs in Japan
1. Obtain the Manufacturing and Marketing License: Companies must obtain the corresponding license before they can conduct manufacturing or marketing activities for quasi-drugs in Japan. For quasi-drugs manufactured overseas, the foreign manufacturer needs to obtain the "Accreditation of Foreign Quasi-drug Manufacturer".
2. Submit the Quasi-Drug Product Registration and Marketing Approval: Each quasi-drug product must be individually registered and granted marketing approval before it can be sold.
3. Post-Marketing Compliance: Includes quality assurance and compliance reporting.
4. Compliance of Product Claims and Advertising: Similar to cosmetics, all claims and promotional materials for quasi-drugs must strictly comply with Japanese laws and regulations.
REACH24H's Compliance Support Services
We assist international brands in navigating every stage of the Japanese regulatory process:
Product Classification: Determining if your product is a cosmetic or quasi-drug.
License Application Support: Guiding Marketing Authorization Holders (MAHs) through the application process for Cosmetic/Quasi-Drug Manufacturing and Marketing Licenses.
Cosmetic Notification: End-to-end management of the Cosmetic Notification process.
Quasi-Drug Registration: End-to-end management of the approval process, from strategy and dossier preparation to agency liaison.
Japanese INCI Name Application: Support for the submission of Japanese INCI Name applications.
Claims Review: Auditing and advising on compliant product claims and advertising for both cosmetics and quasi-drugs.
For more information and inquiries, please feel free to contact us at customer@reach24h.com.
FAQ
Q1. How to determine whether a product is a quasi-drug?
Pre-evaluation should be conducted based on the intended claims, conformity of active ingredients and additives with the MHLW approved list, and comparison with similar products already on the Japanese market.
Q2. How long does a quasi-drug approval take?
The processing period varies depending on product type and data completeness. The simplest application types generally require 9–12 months, while applications involving new active ingredients may take longer.
Q3. What are the labeling requirements for quasi-drugs?
Quasi-drugs must indicate the following items:
Specification of active ingredients and their quantities
Approved efficacy and usage instructions
Other legally required labeling particulars
Note: Claims for quasi-drugs must be submitted and approved by the regulatory authority during the product registration process before being used on labeling or advertisements.
