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利用者:Akaniji/日米EU医薬品規制調和国際会議日米EU医薬品規制調和国際会議[1]（にちべい—いやくひんきせいちょうわこくさいかいぎ、英：International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) ）は日本、米国、EUの薬事行政官と産業界の代表からなる協議会で、3国によってまちまちである薬事規制を統一するための国際的な協議会である。 is a project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of pharmaceutical product registration. The purpose of ICH is to reduce or obviate the need to duplicate the testing carried out during the research and development of new medicines by recommending ways to achieve greater harmonisation in the interpretation and application of technical guidelines and requirements for product registration. Harmonisation would lead to a more economical use of human, animal and material resources, and the elimination of unnecessary delay in the global development and availability of new medicines while maintaining safeguards on quality, safety, and efficacy, and regulatory obligations to protect public health. ICH guidelines have been adopted as law in several countries, but are only used as guidance for the U.S. Food and Drug Administration.[2] 経緯In the 1980s, what is today the European Union began harmonising regulatory requirements. In 1989, Europe, Japan, and the United States began creating plans for harmonisation; ICH was created in April 1990 at a meeting in Brussels, Europe. 構成Seven parties that represent the regulatory bodies and the research-based industries of the founding members are responsible for the decision making process: the European Commission, the European Medicines Agency (EMEA), the European Federation of Pharmaceutical Industries and Associations (EFPIA), the Ministry of Health, Labour and Welfare, the 1986 Japan Pharmaceutical Manufacturers Association (JPMA), the Food and Drug Administration (FDA), and the Pharmaceutical Research and Manufacturers of America (PhRMA). 工程The ICH process consists of five steps: Step 2: Confirmation of EWG consensus by the SC Step 3: Regulatory consultation and discussion
The draft becomes subject of consultation in the three regions. It is published in the European Union (as draft CHMP or CVMP guideline), Japan (after translation by MHLW), and the USA (as draft guideline in the Federal Register) and everybody within these regions can comment on it. There is also an opportunity for companies, associations and authorities in non-ICH regions to comment on the draft, which is distributed by IFPMA and WHO. After obtaining all consultation results, the EWG will be resumed. A new rapporteur will be appointed from the regulatory party, preferably from the same region as the previous rapporteur. The same procedure described in Step 1 is used to address the consultation results into the Step 2 Final Document. The draft document to be generated as a result of the Step 3 phase is called Step 4 Experts Document.
If industry and regulatory EWG members agree on the alterations as a result of the consultation, the Step 4 Experts Document is signed by the EWG regulatory experts only (Step 4 Experts Signoff) and submitted to the SC to request adoption as Step 4 of the ICH process.
If there is no agreement in the EWG within the time frame the SC may extend the time frame, abandon the current draft and resume the process from Step 1, suspend or abandon the harmonization project. Step 5: Implementation 関連項目脚注
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