Mullin Reelected ICH Management Committee Chair

At the 11/16-11/10 International Council on Harmonization (ICH) meeting in Singapore, the ICH management committee reelected CDER associate director for strategic initiatives Theresa Mullin to a one-year term as the committee chair. A meeting report also indicates that the assembly regulatory members adopted the new ICH Q12 guidance on the technical and regulatory considerations for pharmaceutical product lifecycle management. The guidance “aims to promote innovation and continual improvement in the pharmaceutical sector, and strengthen quality assurance and reliable supply of product, including proactive planning of global supply chain adjustments.”

The assembly also adopted an E9(R1) addendum to defining the appropriate estimand for a clinical trial/sensitivity analyses, and a new M9 guidance on biopharmaceutics classification system-based biowaivers.