A Primary Purpose of the ICH Is To: – (FIND THE ANSWER)
The International Conference on Harmonization (ICH) is an organization formed to achieve consensus on standards for the trial and promotion of drugs and biologics. The primary purpose of the ICH is to harmonize drug regulations across countries in the European Union (EU), Japan, and the United States (US) and to facilitate the global development and registration of new products.
The ICH has established a variety of guidelines that are designed to ensure the safety, efficacy, and quality of drugs. The ICH’s most widely known guideline is the Good Clinical Practice guideline. This guideline outlines the responsibilities and expectations for the conduct, monitoring, reporting, and documentation of clinical trials. It is designed to protect the rights of human participants, ensure trial data integrity, and promote ethical clinical practices.
The ICH also created an addendum to the GCP guideline, called E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1). This addendum sets out a unified standard for the EU, Japan, and the US to ensure the safety and efficacy of drugs and biologics. It also requires sponsors and researchers to report serious adverse events and ensure the proper maintenance of trial records.
The ICH also encourages the sharing of clinical trial information as part of its mission to develop and register new products. It has also developed guidelines to protect and promote public access to data generated from clinical trials, and this includes the safety and efficacy data.
In summary, the primary purpose of the ICH is to promote international collaboration and harmonization of drug regulations across countries in the EU, Japan, and the US. The ICH has established a variety of guidelines to ensure the safety, efficacy, and quality of drugs, as well as to promote public access to clinical trial data.