Standards for Marketing Approval of Vitamin Preparations in Japan

Standards for Marketing Approval of Vitamin Preparations (Japan)

The Standards for Marketing Approval of Vitamin Preparations were issued by the Pharmaceuticals and Medical Devices Agency of Japan as Notification PB No.90 on February 1, 1985 and finally revised on March 22, 1995. These standards set regulatory criteria for oral vitamin preparations used for alleviating symptoms that vitamins are effective against and for nutritional supplementation. Preparations not conforming to these standards require submission of efficacy and safety documents and justification for combinations. (PMDA, 000272496.pdf).

Scope

Vitamin preparations under these standards are oral formulations containing one or more vitamins intended for symptom alleviation or vitamin supplementation. (PMDA, 000272496.pdf).

Active Ingredients

Permitted active ingredients and their allowable combinations are listed in Table 1. The standards define specific inclusion rules for preparations mainly consisting of Vitamin A, D, E, B1, B2, B6, C and various combinations thereof. Limited numbers of ingredients from certain columns may be combined based on those rules. (PMDA, 000272496.pdf).

Quantities of Active Ingredients

Active ingredient quantities must conform to limits:

• Maximum daily dose, minimum daily dose, maximum single dose, and minimum single dose are specified in Table 1 for both main ingredients and additional vitamins.
• When multiple ingredients from specified columns are combined (e.g., two from Column I or VIII), the sum of fractional values based on their dose limits must fall within defined bounds. (PMDA, 000272496.pdf).

Dosage Forms

Approved dosage forms include capsules, granules, pills, powders, electuaries, tablets, jelly‑type drops, or oral liquids. (PMDA, 000272496.pdf).

Dosage and Administration

• In principle, vitamin preparations shall not exceed three doses per day.
• Preparations with dosage instructions for infants under 3 months old are prohibited.
• Capsules, pills or tablets over 6 mm intended for children under 5 years are not permitted; smaller forms have corresponding age restrictions.
• For people under 15 years, daily and single dose limits are adjusted by age coefficients from Table 2. (PMDA, 000272496.pdf).

Indications

Indications for each type of vitamin preparation must fall within the scope defined in Table 3 of the standards. These include relief of specific deficiency symptoms and conditions such as dryness of the eyes (Vitamin A), prevention of rickets (Vitamin D), peripheral circulatory disturbances (Vitamin E), and support during pregnancy, lactation and recovery from illness. (PMDA, 000272496.pdf).

Summary

These standards provide the regulatory framework for marketing oral vitamin preparations in Japan. Conformance with active ingredient lists, quantity limits, dosage forms, administration rules, indications and age‑based restrictions is essential for marketing approval. (PMDA, 000272496.pdf).