- The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) was established to standardize and harmonize regulatory requirements for drug development and registration across different countries.
- The primary goal is to ensure that safe, effective, and high-quality medicines are developed efficiently while minimizing duplication of efforts in regulatory submissions.
Key Objectives of ICH:
- Promote harmonization of regulatory guidelines among different regions (US, EU, Japan, etc.).
- Reduce time and cost in pharmaceutical development.
- Improve drug safety, efficacy, and quality globally.
- Minimize unnecessary animal testing and human trials.
- Ensure scientific and technical advances are incorporated into regulations.
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