Food and Drug Safety Center (FDSC)

The Food and Drug Safety Center (FDSC) provides safety testing of pharmaceuticals, medical devices, health foods, and other related products.

This page provides detailed information about FDSC’s non-clinical studies, examples of disease models, and case studies.

We hope it serve as a useful reference when selecting a contract organization for your needs.

Features of the FDSC’s Non-Clinical Testing Services

Providing Safety Testing Based on Multiple Guidelines

FDSC provides high-quality safety testing in compliance with various guidelines.

In addition to the Ministry of Health, Labour and Welfare (MHLW) guidelines, they perform evaluations according to the recommendations by international standards such as ISO 10993, FDA, ASTM, and OECD.

Since 1970, FDSC has been engaged in a wide range of safety evaluations related to food, pharmaceuticals, and medical devices.

As of October 2024, the Center had conducted over 70,000 tests in total.

They have worked with numerous manufacturers for their biological safety testing of medical devices.

Beyond providing test results, FDSC offers comprehensive follow-up services, including consultations regarding inquiries from regulatory authorities based on study outcomes.

Extensive Range of Safety Tests

FDSC supports a broad spectrum of safety tests, including cytotoxicity, skin sensitization, local irritation, systemic toxicity, genotoxicity, pathological examinations, implantation, blood compatibility, extraction efficiency, and quality control tests and more.

Since 1980, they have provided many GLP compliant studies and can also perform quality control testing in accordance with GMP standards.

Partnered Organizations

No information regarding partnered organizations was found on the official website.

Example of a Non-Clinical Study at the FDSC

Single-Dose Toxicity (Acute Toxicity) Study

Extracts of pharmaceuticals, chemicals, or medical materials are administered once to animals (e.g., mice or rats) orally, intravenously, or dermally, to observe potential toxic effect.

Evaluation items include general condition, body weight change, and pathological examination.

Repeated-Dose Toxicity Study

This study aims to evaluate toxicological changes in animals administered daily or implanted with medical devices over periods ranging from two weeks to one year.

Mice, rats, and rabbits are used as test species, with evaluations including general condition, body weight change, food and water intake, urinalysis, hematology, ophthalmology, and pathological examination.

Company Information

The Food and Drug Safety Center conducts tests in accordance with international standards such as ISO 10993, FDA, ASTM, and OECD, as well as the guidelines of Japan’s Ministry of Health, Labour and Welfare (MHLW).