"ICH guidelines.....achieve greater harmonisation worldwide to ensure that safe, effective and high quality medicines are developed" - ICH (International Council for Harmonisation)

SETTING AN AMBITIOUS TARGET

One global bioanalysis guideline

In 2016, the regulatory authorities in US (FDA), Europe (EMA), Canada, Japan, China, and Brazil set an ambitious target; for the first time ever to write one common guideline for “Bioanalytical Method Validation and Study Sample Analysis” under the framework of The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).

Our founder, Marianne Scheel Fjording, was selected to join the ICH M10 expert working group, representing the US pharma industry. As a Topic Leader, she was actively involved in writing the guideline together with the working group, managing industry comments and securing alignment with the US pharma industry.

MISSION COMPLETED

ICH M10 is being implemented

In May 2022, the work was completed, and the guideline was signed by all the participating regulatory authorities. Starting with EMA in January 2023, the guideline is being implemented in each region/country and will be providing recommendations for the validation of bioanalytical assays and outlining principles to improve the quality of bioanalytical data in the development and market approval of chemical and biological drugs.

ADOPTION OF ICH M10 IN PHARMA, BIOTECH, AND CRO

Impacting all companies working with PK (pharmacokinetic)

Now the real work begins. Once the guideline is implemented in each region/country, it will regulate bioanalytical method validation and study sample analysis for everybody working in these areas, and it is important to be fully ready for this. As “co-author” of the guideline, and knowing practically every comma, our expert consultant Marianne can assist you.