ICH

Question 1

Who are the ICH and what do they do/ type of work do they do/ what type of guidelines do they produce
CGI

Answer 1

They are a combination of regulatory authorities and pharma industry working together to establish the best practices.
- They provide guidance documents, which many of them are now part of the regulatory requirements.
Guidance docs are:
Q – chemistry, manufacturing, controls
S – in vivo and in vitro pre clincal studies
E clincal studies in human subjects
M cross-cutting subjecting that doesn’t fit into QSE catergories
- Vastly improved the drug approval process

Question 2

Importance of ICH, RDP

Answer 2

Promotion of public health through international harmonisation that contributes to:
- Prevention in the unnecessary duplication of clinical studies and post market clinical evaluations
- Developing, manufacturing, registering and supervision of new medicine.
- Reduction of unnecessary animal testing without compromising the safety and efficacy of medicines