What is International Conference on Harmonisation (ICH)?
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ICH stands for the "International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use." It is an international organization that brings together regulatory authorities and the pharmaceutical industry from different regions of the world to develop and promote harmonized guidelines and standards for the development, registration, and post-approval of pharmaceutical products.
The primary goal of ICH is to reduce duplication of efforts in drug development and streamline the process of bringing new drugs to market by creating a common set of standards that are accepted by regulatory agencies in various countries. This helps to facilitate the global development and registration of new pharmaceutical products and ensures that these products are of high quality, safe, and effective.
ICH was established in 1990 as a result of discussions between regulatory authorities and industry representatives from the European Union, Japan, and the United States. Since then, other regions and countries have also become involved, expanding the reach of ICH guidelines. The organization works on developing guidelines in various areas, including quality, safety, efficacy, and multidisciplinary topics related to pharmaceuticals.
ICH guidelines cover a wide range of topics related to drug development, clinical trials, manufacturing, quality control, safety reporting, and more. One of the well-known outcomes of ICH's work is the ICH-GCP (Good Clinical Practice) guidelines, which set the standards for conducting clinical trials involving human participants, as I mentioned in my previous response.
Overall, ICH plays a critical role in promoting international collaboration, regulatory convergence, and efficient drug development processes that benefit both the pharmaceutical industry and the public by ensuring the availability of safe and effective medicines.
