3/84 NEW TESTING STANDARDS - Pharmaceuticals Law

The Ministry of Health and Welfare is moving up to establish new "Good Clinical Testing Standards" for fiscal year 1984 to guide various testing institutes following a series for scandals in 1983. An "Internal Research Board" to verify testing is likely to be included. The Ministry is also moving to establish retesting standards. In line with an amendment to the pharmaceuticals law that went into effect in April 1980. According to the provisions of Article 14, drugs must be retested 6 years after initial approval. This applies to new composites and new ways of applying the drug. Retesting is required after 4 years for drugs for which new effects have been added or where usage methods or volumes have been changed.

THE JAPAN LAWLETTER, March, 1984. By Roderick Seeman