medicines-medical devices-regulatory affairs
This post is an attempt to provide basic information on the International Council for Harmonisation (ICH) and its functions. Click on the ‘+’ sign next to each heading to access the information under each heading. Source: ICH Please share any…
Health Canada has published an update on Update on the Implementation of ICH’s Q12 Guideline and Pilot Programs. What is the ICH 12 guideline about? The ICH guideline entitled, “Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management” (ICH Q12)…
The International Council for Harmonisation (ICH) has published its draft Q13 guideline on continuous manufacturing of drug substances and drug products, for consultation. Perceived problem necessitating this guideline According to the ICH Concept paper of November 2018, there is a…