International – ICH Q14: Pharma groups want clarity on benefits of enhanced approach

Pharmaceutical industry groups questioned whether following the enhanced approach in International Council for Harmonization (ICH) Q14 guidance will confer regulatory relief for manufacturers that follow this method in developing an analytical procedure.

They also asked for recommendations for when an enhanced approach should be followed, called for greater alignment with the ICH Q2(R2) guideline and requested more examples showing multivariate approaches to analytical method development.

The comments were made in response to the US Food and Drug Administration’s (FDA) call for feedback on the two ICH draft guidelines, and echo earlier comments submitted to the European Medicines Agency (EMA). (RELATED: Pharma groups question enhanced approach in Q14, call for more alignment between Q14 and Q2(R2), Regulatory Focus 29 August 2022)…