Final answer:
The ICH established in 1990 key guidelines for clinical research to ensure safety, quality, and efficacy in drug development. It created minimum standards for various aspects of clinical trials along with documents on general trial considerations and analytical procedure validation. The guidelines aim at harmonization for consistent global drug development and approval.
Step-by-step explanation:
The International Conference on Harmonization (ICH) held in 1990, laid the groundwork for a harmonized approach to the regulation of clinical trials worldwide, with the primary aim of ensuring that all aspects of drug development, including safety, quality, and efficacy, are addressed. This conference sought to establish minimum standards for clinical research, and ICH guidelines have covered various areas including the design, conduct, safety, and reporting of clinical trials. Some of the key documents produced by the ICH include the E8 guideline on general considerations for clinical trials, providing a framework for the conduct of trials, and Q2(R1) on the validation of analytical procedures, addressing the methodology and documentation necessary to ensure the quality and reliability of analytical data.
Further guidance has been set forth in documents such as EMA's CPMP/ICH/286/95 on non-clinical safety studies, which is crucial for ensuring the safety of human subjects before commencing clinical trials. The ICH has been influential in shaping the regulatory landscape for drug development, with a focus on harmonization to facilitate the global development and approval of pharmaceuticals.