Drug regulation is a global effort, with country specific agencies each with their own unique perspective on the regulatory challenges within their own borders. There is also an international group known as the ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) dedicated to bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration. The founding members include the FDA, EMA, and MHLW/PMDA (the Japanese regulatory authority) and participants include a long list of individual country agencies and industry groups. The ICH working groups prepare guidelines that bring together different regulatory perspectives into a common document which is agreed to by its members. These guidelines form the basis for international drug regulation and are a good first source of information on any regulatory topic (especially if the strategic plan includes marketing in more than one country).

An example of such a guideline is M10, a guideline on bioanalytical method validation. The ICH draft guideline was issued in February, 2019 and is open for comment by member countries (see here for the page of ICH M category guidelines; look for M10 in the drop down list). The FDA has issued a draft copy of M10 for the purposes of obtaining US feedback (see the notice in the Federal Register and the draft guidance page). That feedback is due by September 25, 2019. It’s probably not surprising that the M10 guideline is very similar to the FDA guidance on bioanalytical method validation published in May 2018 (see here for my previous post on this guidance) since the agency actively participates in the M10 working group (and Dr. Brian Booth is the group’s chair). If you work on validated bioanalytical methods for reporting data from GLP or GMP studies for global regulatory applications, you should be familiar with both the ICH guideline and the FDA guidance.

Text Copyright © 2019 Katrina Rogers