FDA Updates Interchangeable Pharmacopeia Guidelines on Quality Testing to Include Health Canada

The FDA updated several ICH guidance documents to reflect Canada’s adoption of interchangeable chapters from the U.S., European and Japanese pharmacopeias.

International recognition of the texts on specific topics allows drugmakers to avoid performing redundant pharmaceutical quality testing — including sterility, particulate and microbiological contamination tests — when seeking approval in different countries and regions.

In addition, it allows regulators to avoid requiring justification for the use of other international methods. Health Canada implemented the 10 ICH annexes in October 2010.