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ICH guidelines

The document summarizes the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines. The ICH was formed to provide uniform technical requirements and standards for drug quality, safety and efficacy. It has guidelines in 14 quality, 11 safety, and 18 efficacy areas. The ICH members are regulatory authorities and pharmaceutical industry representatives from Europe, Japan and the US. It was established in 1990 in Brussels to harmonize technical requirements between these major regions to ensure safe, effective and high quality medicines.

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ICH Guidelines Prepared by Varsha Jindaniya M.Pharm Pharmaceutical Department of NIET college
Introduction History Members of ICH Guidelines Introduction-The International Council for Harmonisation of Technical Requirements for pharmaceutical human use ICH guidelines use to maintain the efficacy, safety and quality of drugs. ICH guidelines motives to provide uniform standards for technical requirements for pharmaceuticals for human use. ICH aims to provide uniform standards for technical requirements for pharmaceuticals for human use
Quality- Stability, impurity, GMP etc .It's all about the quality assurance . There are 14 guidelines in quality assurance. Safety- In this safety guidelines the carcinogenicity, genotoxicity, reprotoxicity etc it's all comes under this safety guidelines. There are 11guidelines in safety. Efficacy- In this guidelines the clinical trials, pharmacogenomics, pharma vigilance etc all are comes under this efficacy guidelines. There are total 18 guidelines comes in this. Multidisciplinary- Med. DRA, CTD (common tech documents) , electronics STD etc all are in this guidelines. There are 10 guidelines in this.
Members of ICH - 1. In Japan - Ministry of Health Labour and Welfare (MHLW) Japan Pharmaceutical Manufacturing Association (JPMA) 2. In Europe- The Members are the European Union (EU) European Federation of Pharmaceutical Industries and Association (EFPIA) 3. In USA - The Members are The Food and Drugs Administration (FDA) The Pharmaceutical Research and Manufacturers of America (Pharma) Additional Members + Observers WHO, EFTA(European Free Trade Association), Canada, Australia, Non- voting Members IFPMA(International Federation of Pharmaceutical Manufactures Association) Representative. These all members are as a observers.
History- 1980 - European community 1989 - WHO Conference on Drug Regulatory Authorities This conference conduct in Paris. 1990 - Birth of ICH. this conference conduct in Brussels. -Europe, Japan, USA This conference is conducted by European Federation of Pharmaceutical Industries (EFPIQ) in Brussels. Six Party Experts Working Groups 1990 - In Tokyo steering Committee. Commitment and process decides in this conference.
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