ICH
The global body that harmonises drug regulation across the US, EU, Japan, and other markets.
Definition
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) brings together regulators and industry from the US (FDA), EU (EMA), Japan (PMDA), and increasingly Canada, Brazil, China, Korea, and Switzerland. ICH guidelines (E1–E20 efficacy, S1–S12 safety, Q1–Q14 quality, M-series multidisciplinary) define common standards so a single dataset can support submissions in multiple regions.
See also
- EMA — The EU regulatory agency that authorises and supervises medicines for use across member states.
- PMDA — Japan's medicines regulator.