Japan Releases Two Instructions on Medicated Soap Market Access Requirements

Takehome:

Japan MHLW released two instructions for medicated soap market access requirements on Mar 29, 2018. The first instruction regulates the basic requirements for application of medicated soap marketing approval. The second instruction indicates the detailed information on how to fill out the marketing license application form.

Requirements for Application for Marketing Approval of Medicated Soaps

According to Pharmaceutical and Medical Devices Law, medicated soaps (including facial cleansing products) are classified as quasi drugs, which require application for marketing approval. The first instruction regulates the basic requirements for applicable scope, type, concentration and specification of active ingredients, type, concentration and specifications of additives, usage, dosage, efficacy and function of medicated soaps when applying for marketing approval.

The specific requirements are as follows:

1. Scope of application: the instruction only applies to medicated soap.

2. The type and concentration of active ingredients:

For applicants wanting to use 2 active ingredients in medicated soaps, only the following two options are permitted:

3. Specification: the active ingredients of P (see the above table) are listed on the Japanese Pharmacopoeia while the active ingredients of Q (see the above table) are listed on Japanese Standards of Quasi-drug Ingredients.

4. The types, specifications and dosages of additives shall be in accordance with the List of Additives of Quasi Drugs released in 2008.

5. Dosage forms: solid, semisolid, liquid and etc.

6. Functions: medicated soaps are allowed to have and claim the following two functions:

• Medicated soap for cleansing, anti-bacteria and deodorization;
• Medicated soap for cleansing and preventing chapping and roughness of skin.

Different function requires that the product contains one of the active ingredients listed in the right column of the table below.

The second instruction indicates the detailed information on how to fill out the marketing license application form of medicated soaps, stakeholders wanting to know the details can refer to it in our database.