What is ICH and How does it impact regulatory and drug development
What is ICH and Why?
ICH stands for International Council for Harmonization.
To be more precise, it is The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use.
ICH is established in 1990.
It started as a group of Pharma/Biotech Industry and Regulatory Agencies such as FDA from USA, Europe and Japan to discuss and harmonize scientific and technical aspects of drug registrations.
Now, there are many other countries that joined ICH (Korea, China, Canada etc.).
They meet three times a year and work on guidance to harmonize drug development on Safety, Efficacy and Quality aspects.
ICH Guidelines are a goldmine of information for understanding drug development.
When ICH Guidance or combined with regional guidance document, you have all powerful tools for development of drugs and information that regulators want to see to approve your drug.
There are Four types of guidance documents in ICH.
Q — Stands for Quality — These guidance documents provides information on building Quality in your drug. They discuss CMC or Chemistry Manufacturing and Controls aspects of drug development.
S- Stands for Safety — These guidance documents provides information on establishing Safety profile of your drug before trial can be started in humans. They discuss Non-Clinical aspects of drug development.
E- stands for Efficacy — These guidance documents provides information on establishing Efficacy profile of your drug. They discuss Clinical aspects of drug development.
M — stands for Multi-disciplinary — These guidance documents provides information that involve more than one of the above disciplines at a time. They discuss some combined aspects of drug development.
Together, these ICH guidelines help you develop drugs.
For example:
- Safety guidelines suggest you about the non-clinical testing that you need to work on before submitting First In Human studies.
- Quality guidelines suggest you about setting up specifications to control drug substance and drug product or determining the stability requirements.
- Efficacy guidelines suggest about designing the clinical trials.
- Multidisciplinary guidelines suggest about how all this information can be submitted to regulatory authorities in a common format.
How to use the ICH guidelines
Use ICH guidelines to understand the overall drug development.
Use them to gain deeper understanding into the general requirements for Non-Clinical, CMC and Safety aspects of drug development.
To go much deeper, you may need guidance documents from individual regulatory authorities.
For example, ICH guidelines will help you determine how doses used in Non-clinical studies can pave a way to safe starting dose in humans. However, to understand how to calculate those doses, you may need an FDA guidance.
