International Council for harmonisation of technical requirements for Pharmaceuticals for Human Use - wikipedia International Council for harmonisation of technical requirements for Pharmaceuticals for Human Use This article needs additional citations for verification. Please help improve this article by adding citations to reliable sources. Unsourced material may be challenged and removed. ( January 2009 ) The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use ( ICH ) 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 eliminate 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, non-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. Contents 1 History 2 Structure 2.1 Step 2 : Confirmation of EWG consensus by the SC 2.2 Step 3 : Regulatory consultation and discussion 2.3 Step 4 : Adoption of an ICH harmonised tripartite guideline 2.4 Step 5 : Implementation 3 See also 4 Notes 5 External links History 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 ; International Council of Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use ( ICH ) was created in April 1990 at a meeting in Brussels. In 2015, International Conference on Harmonisation changed its name to the International Council for Harmonisation while becoming a legal entity in Switzerland. On 23 October 2015 ICH conducted the initial meeting of their new assembly. Structure The ICH has four major parts : ICH Steering Committee ICH Coordinators ICH Secretariat ICH Working Groups The Steering Committee, made of six ICH Parties, governs the ICH, determining the policies and procedures, selecting topics for harmonisation and monitoring progress of harmonisation initiatives. The ICH consists of : European Commission European Federation of Pharmaceutical Industries and Associations ( EFPIA ) Ministry of Health, Labour and Welfare ( Japan ) ( MHLW ) Japan Pharmaceutical Manufacturers Association ( JPMA ) Food and Drug Administration ( FDA ) Pharmaceutical Research and Manufacturers of America ( PhRMA ) The ICH Coordinators represents each ICH Party to the ICH Secretariat on a day - to - day basis. The ICH Secretariat is primarily concerned with preparations for, and documentation of, meetings of the Steering Committee as well as coordination of preparations for Working Group ( EWG ( Expert Working Group ), IWG ( Implementation Working Group ), Informal WG ) and Discussion Group meetings. The ICH Working Groups are created by the Steering Committee when a new topic is accepted for harmonisation, and is charged with developing a harmonised guideline that meets the objectives outlined in the Concept Paper and Business Plan. Face - to - face meetings of the EWG will normally only take place during the biannual SC meetings. Interim reports are made at each meeting of the SC. If consensus is reached the EWG will sign the Step 2 Experts Signoff sheet and submit it to the SC to request adoption. If there is no agreement in the EWG within the time frame the SC may extend the time frame, suspend or abandon the harmonization project. Step 2 : confirmation of EWG consensus by the SC Step 2 is reached when the SC agrees, based on the report of the EWG, that there is sufficient scientific consensus on the technical issues for the draft guideline. This text is signed off by the SC as Step 2 Final Document. 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. Step 4 : adoption of an ICH Harmonised Tripartite guideline Step 4 is reached when the SC agrees that there is sufficient scientific consensus on the technical issues. If one industry party has strong objections to the adoption of the guideline due to deviations of the revised draft from the original consensus the regulatory parties may agree that a revised document should be submitted for further consultation. In this case, the EWG discussion may be resumed. The Step 4 Final Document is signed off by the SC signatories for the regulatory parties of ICH as an ICH Harmonised Tripartite Guideline. Step 5 : implementation The ICH Harmonised Tripartite Guideline moves immediately to the final step of the process that is the regulatory implementation. This step is carried out according to the same national / regional procedures that apply to other regional regulatory guidelines and requirements, in the European Union, Japan, and the United States. Information on the regulatory action taken and implementation dates are reported back to the SC and published by the ICH Secretariat on the ICH website and in the annual press statement. See also Australia New Zealand Therapeutic Products Authority CIOMS Guidelines Clinical study report Clinical trial Common Technical Document Council for International Organizations of Medical Sciences Good clinical practice ( GCP ) Health Canada Health Sciences Authority -- Singapore IFPMA -- & -- International Pharmaceutical Federation National pharmaceuticals policy Pharmaceutical policy Pharmacopoeia Regulation of therapeutic goods State Food and Drug Administration -- China Uppsala Monitoring Centre Notes Jump up ^ Bankert, Elizabeth A ; Robert J. Amdur ( 2006 ). Institutional Review Board. Jones & Bartlett Publishers. p. 281. Jump up ^ ICH Makes Organizational Changes, Zachary Brennan, 26 October 2015, Regulatory Affairs Professionals Society ^ Jump up to : ICH is now International Council for Harmonisation -- a Legal Swiss Entity, James Lind Institute Jump up ^ ( 1 ) External links Official website Analysis : New ICH M2 Requirements into eCTD NMV ( = RPS ) Retrieved from `` https://en.wikipedia.org/w/index.php?title=International_Council_for_Harmonisation_of_Technical_Requirements_for_Pharmaceuticals_for_Human_Use&oldid=820795186 '' Categories : Clinical research Pharmaceuticals policy Drug safety Life sciences industry Hidden categories : Articles needing additional references from January 2009 All articles needing additional references Talk Contents About Wikipedia Deutsch Español Français Italiano Polski Edit links This page was last edited on 16 January 2018, at 17 : 25. Text is available under the Creative Commons Attribution - ShareAlike License ; additional terms may apply. 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Question: a primary purpose of the international conference on harmonisation (ich) is to
Answer: to reduce or eliminate 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