Three major pharmaceutical industry groups—two in the US and one in India—have called for changes to the US Food and Drug ...
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 the adoption of Annex 2 to the guideline on Good Clinical ...
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 ...
The ICH E20 guideline, released as a Step-2 draft in June 2025, establishes globally harmonised principles for the planning, conduct, analysis, and interpretation of ...
The new guidelines will address bioanalytical method validation and biopharmaceutics classification system-based biowaivers. On Oct. 19, 2016, the International Council for Harmonization (ICH) ...
The final ICH E6 (R3) Good Clinical Practice (GCP) Guidelines were published on 6 th January 2025, updating the framework for clinical trials to reflect modern trial designs, technology, and data ...
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 ...
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