The International Council for Harmonisation (ICH) announced on 8 November the adoption of its Q5A(R2) guideline on viral safety evaluation of biotechnology products as well as a guideline on ...

This article reviews the scope, key principles, methodological expectations, and regulatory implications of ICH E20, and ...

The flexibility and incompatibility of ICH Q12 guidelines with current EU legislations raise complications. As the world’s economy is increasingly threatened by new barriers to trade, the ...

The International Council for Harmonisation (ICH) has announced two new guidelines, with one (M9) providing recommendations to support the biopharmaceutics classification of medicinal products, while ...

In anticipation of these new guidelines, TransCelerate assembled a team of experts to evaluate the guidance and develop tools to support adoption of ICH E6 (R3). The array of tools announced today ...

Experts have recommended ICH Q10 PQS (International Council for Harmonisation - Pharmaceutical Quality System) guidelines on pharma quality systems for effective implementation of revised Schedule M ...

Data quality frameworks reshape pharmaceutical quality systems in Pharma 4.0, integrating digital maturity, automation, and ...

The new guidelines will address bioanalytical method validation and biopharmaceutics classification system-based biowaivers. On Oct. 19, 2016, the International Council for Harmonization (ICH) ...