When working with the common technical dossier (CTD), the structure of Module 2 “follows the scope and outline of the Body of Data in Module 3,”1
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guideline on Registration of Pharmaceuticals for Human Use (M4)1
While everyone is facing new speed to market expectations, we should consider and discuss why global regulatory barriers are increasing, why science- and risk-based strategies often mean more data are required, and why regulatory approval for new technologies and new medicines seems more challenging than ever before. We can no longer afford to delay innovation, product and process...
Management of global postapproval chemistry, manufacturing, and controls (CMC) changes is a growing challenge for industry with many issues. ICH Q12 (Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management) is a transformative document shaping global regulatory postapproval submissions that will help alleviate some of these issues.
The latest ICH guideline, ICH Q12,1
On 20 November 2019, the ICH Assembly endorsed the Q12 guideline, “Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management,” at its biannual meeting in Singapore. This transformational guideline has a wide scope of applicability across pharmaceutical drug substances and products (both chemical and biological), drug-device combination products that meet the...