The answer to how many ICH quality guidelines there are is not a fixed number, as guidelines are continuously developed, revised, and implemented. Instead of a single number, it's more accurate to understand that the ICH guidelines are organized into four major categories.
However, we can provide context regarding the types of guidelines:
- Quality (Q): These guidelines cover all aspects of quality assurance.
- Safety (S): These address preclinical safety testing.
- Efficacy (E): These cover clinical studies.
- Multidisciplinary (M): These cover topics that cut across the other three categories.
Within each category, there are numerous specific guidelines. Trying to provide a definitive count is misleading because the number changes over time. Accessing the official ICH website is the best way to get precise details on current, active guidelines within each category.
Therefore, while we cannot provide a fixed number, understanding the framework of four categories is the most important takeaway regarding ICH guidelines.
