After Delay Due to Pandemic, Japan Announces Listing of Approved Pharmaceuticals to be Released

The new edition of the Japanese Pharmacopoeia, the official compendium of medicines approved by the government for use in the country, will include 33 new pharmaceuticals, among them antibiotics, excipients, and biologics, as well as many unrefined drugs.

Inclusion in the Pharmacopoeia means drugs are deemed to be safe, effective, and useful for medical care and treatment in the country. In this latest edition, listings of 168 products were revised, eight products were deleted and new rules were set out for the control by pharmaceutical manufacturers of elemental impurities such as catalysts or environmental contaminants that may occur naturally or be introduced inadvertently in drugs.

The release of the 18th edition of the Pharmacopoeia was delayed because of the COVID-19 pandemic. First published in 1877, the official standard listing of pharmaceuticals approved for use in Japan by the Pharmaceuticals and Medical Devices Agency is generally revised every five years. The last edition was released in 2016, but the new edition is not scheduled for release until next year.