International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use: Difference between revisions

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Line 1: {{Short description\|Initiative to promote public health}} ~~{{more citations needed\|date=January 2009}}~~ The '''International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use''' ('''ICH''') is an initiative that brings together regulatory authorities and [[pharmaceutical industry]] to discuss scientific and technical aspects of [[Drug development\|pharmaceutical product development]] and registration. The mission of the ICH is to promote [[public health]] by achieving greater harmonisation through the development of technical Guidelines and requirements for pharmaceutical product registration.<ref>{{cite book \|author1=Mullin Theresa \|editor1-last=Gallin \|editor1-first=John I. \|editor2-last=Ognibene \|editor2-first=Frederick P. \|editor3-last=Lee Johnson \|editor3-first=Laura \|title=Principles and Practice of Clinical Research \|date=17 Nov 2017 \|publisher=Academic Press \|page=88 \|chapter=International Regulation of Drugs and Biological Products}}</ref>▼ Harmonisation leads to a more rational use of human, animal and other resources, the elimination of unnecessary delay in the global development, and availability of new medicines while maintaining safeguards on quality, [[drug safety\|safety]], efficacy, and regulatory obligations to protect public health.~~mangso~~ Junod notes in her 2005 treatise on Clinical Drug Trials that "Above all, the ICH has succeeded in aligning clinical trial requirements."<ref name="junod05">{{cite book \|last1=Junod \|first1=Valerie \|title=Clinical drug trials - Studying the safety and efficacy of new pharmaceuticals \|date=2005 \|publisher=Bruylant \|location=(thesis for Faculté de droit de Genève) Bruxelles \|page=107}}</ref>▼ The '''International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use''' ('''ICH''') is an initiative that brings together regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceutical product development and registration. ▲The mission of the ICH is to promote public health by achieving greater harmonisation through the development of technical Guidelines and requirements for pharmaceutical product registration.<ref>{{cite book \|author1=Mullin Theresa \|editor1-last=Gallin \|editor1-first=John I. \|editor2-last=Ognibene \|editor2-first=Frederick P. \|editor3-last=Lee Johnson \|editor3-first=Laura \|title=Principles and Practice of Clinical Research \|date=17 Nov 2017 \|publisher=Academic Press \|page=88 \|chapter=International Regulation of Drugs and Biological Products}}</ref> ▲Harmonisation leads to a more rational use of human, animal and other resources, the elimination of unnecessary delay in the global development, and availability of new medicines while maintaining safeguards on quality, safety, efficacy, and regulatory obligations to protect public health.mangso ==History== In the 1980s the [[European Union]] began harmonising regulatory requirements. In 1989, Europe, Japan, and the United States began creating plans for harmonisation. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was created in April 1990 at a meeting in [[Brussels]]. ICH had the initial objective of coordinating the regulatory activities of the European, Japanese and United States regulatory bodies in consultation with the pharmaceutical trade associations from these regions, to discuss and agree the scientific aspects arising from product registration.<ref>{{cite book \|last1=Teasdale \|first1=Andrew \|last2=Elder \|first2=David \|last3=Nims \|first3=Raymond W. \|title=ICH Quality Guidelines: An Implementation Guide \|date=9 Oct 2017 \|publisher=John Wiley & Sons \|page=1}}</ref> Since the new millennium, ICH's attention has been directed towards extending the benefits of harmonisation beyond the founding ICH regions.{{cn\|date=November 2023}} In 2015, ICH underwent several reforms and changed its name to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use while becoming a legal entity in Switzerland as a non-profit association.<ref>[http://www.raps.org/Regulatory-Focus/News/2015/10/26/23473/ICH-Makes-Organizational-Changes/ ICH Makes Organizational Changes], Zachary Brennan, 26 October 2015, Regulatory Affairs Professionals Society</ref><ref name="jliedu">[http://www.jliedu.com/blog/ich-is-now-international-council-on-harmonisation-a-legal-swiss-entity/ ICH is now International Council for Harmonisation – a Legal Swiss Entity], James Lind Institute</ref> The aim of these reforms was to transform ICH into a truly global initiative supported by a robust and transparent governance structure.<ref>{{cite web \|title=International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) \|url=http://www.ema.europa.eu/ema/index.jsp?curl=pages/partners_and_networks/general/general_content_001865.jsp&mid=WC0b01ac05801df740 \|website=European Medicines Agency\|date = 2018-09-17}}</ref> The ICH Association established an Assembly as the over-arching governing body with the aim of focusing global pharmaceutical regulatory harmonisation work in one venue that allows pharmaceutical regulatory authorities and concerned industry organisations to be more actively involved in ICH’s harmonisation work. The new Assembly met for the first time on 23 October 2015.<ref name="jliedu" /> ==Structure== The ICH comprises the following bodies:<ref>{{cite journal \|last1=Lourenco \|first1=C. \|last2=Orphanos \|first2=N. \|last3=Parker \|first3=C. \|title=The International Council for Harmonisation : Positioning of the future with its recent reform and over 25 years of harmonisation work \|journal=Pharmaceuticals Policy and Law \|date=2016 \|volume=18 \|issue=1–4 \|page=82\|doi=10.3233/PPL-160434 }}</ref> # ICH Assembly # ICH Management Committee Line 19 ⟶ 16: # ICH Secretariat The ICH Assembly brings together all Members and Observers of the ICH Association as the overarching governing body of ICH. It adopts decisions in particular on matters such as on the adoption of ICH Guidelines, admission of new Members and Observers, and the ICH Association’s work plans and budget. Member representatives appointed to the Assembly are supported by ICH Coordinators who represent each Member to the ICH Secretariat on a daily basis.{{cn\|date=November 2023}} The ICH Management Committee (MC) is the body that oversees operational aspects of ICH on behalf of all Members, including administrative and financial matters and oversight of the Working Groups (WGs).{{cn\|date=November 2023}} The MedDRA Management Committee (MC) has responsibility for direction of MedDRA, ICH’s standardised medical terminology. The MedDRA MC has the role of managing, supporting, and facilitating the maintenance, development, and dissemination of MedDRA.<ref>{{cite book \|author1=Mullin Theresa \|editor1-last=Gallin \|editor1-first=John I. \|editor2-last=Ognibene \|editor2-first=Frederick P. \|editor3-last=Lee Johnson \|editor3-first=Laura \|title=Principles and Practice of Clinical Research \|date=17 Nov 2017 \|publisher=Academic Press \|page=92 \|chapter=International Regulation of Drugs and Biological Products}}</ref> The ICH Secretariat is responsible for day-to-day management of ICH, coordinating ICH activities as well as providing support to the Assembly, the MC and Working Groups. The ICH Secretariat also provides support for the MedDRA MC. The ICH Secretariat is located in Geneva, Switzerland.{{cn\|date=November 2023}} The ICH WGs are established by the Assembly when a new technical topic is accepted for harmonisation, and are charged with developing a harmonised guideline that meets the objectives outlined in the Concept Paper and Business Plan. Face-to-face meetings of the WG will normally only take place during the biannual ICH meetings. Interim reports are made at each meeting of the Assembly and made publicly available on the ICH website. Line 42 ⟶ 39: ===''Step 2b'': Endorsement of draft Guideline by Regulatory Members=== ''Step 2b'' is reached when the Regulatory Members of the Assembly further endorse the draft Guideline.<ref>{{cite journal \|last1=Lourenco \|first1=C. \|last2=Orphanos \|first2=N. \|last3=Parker \|first3=C. \|title=The International Council for Harmonisation : Positioning of the future with its recent reform and over 25 years of harmonisation work \|journal=Pharmaceuticals Policy and Law \|date=2016 \|volume=18 \|issue=1–4 \|page=86\|doi=10.3233/PPL-160434 }}</ref> ===''Step 3'': Regulatory consultation and discussion=== ''Step 3'' occurs in three distinct stages: regulatory consultation, discussion, and finalisation of the ''Step 3'' Expert Draft Guideline. * '''Stage I - Regional regulatory consultation:''' The Guideline embodying the scientific consensus leaves the ICH process and becomes the subject of normal wide-ranging regulatory consultation in the ICH regions. Regulatory authorities and industry associations in other regions may also comment on the draft consultation documents by providing their comments to the ICH Secretariat. * '''Stage II - Discussion of regional consultation comments:''' After obtaining all comments from the consultation process, the EWG works to address the comments received and reach consensus on what is called the ''Step 3'' Experts Draft Guideline. Line 57 ⟶ 53: The ICH Harmonised 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 ICH regions. Information on the regulatory action taken and implementation dates are reported back to the Assembly and published by the ICH Secretariat on the ICH website.<ref name=":0">{{~~cite~~Cite web \|date=2022 \|title=Welcome to the ICH Official Website \|url=~~http~~https://www.ich.org/ \|website=International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)}}</ref> ==Work products== Line 63 ⟶ 59: ===Guidelines=== The ICH topics are divided into four categories and ICH topic codes are assigned according to these categories:<ref~~>{{cite~~ ~~web \|title~~name=~~ICH~~":0" ~~website \|url=http://www.ich.org}}<~~/~~ref~~> * Q : Quality Guidelines * S : Safety Guidelines * E : Efficacy Guidelines * M : Multidisciplinary Guidelines ICH Guidelines are ~~not~~lack ~~mandatory~~binding ~~for~~force, ~~anybody~~instead ~~per se but the strength of the ICH process lies in the commitment for implementation~~implemented by ~~ICH~~regulatory ~~Regulatory~~members ~~Members~~through ~~using~~national ~~appropriate~~and ~~national/~~regional ~~tools~~governance.<ref>{{cite book \|last1=van Boxtel \|first1=Chris J. \|last2=Santoso \|first2=Budiono \|last3=Edwards \|first3=Ralph \|title=Drug Benefits and Risks: International Textbook of Clinical Pharmacology \|date=2008 \|publisher=IOS Press \|page=70}}</ref> ===MedDRA=== Line 76 ⟶ 72: ==See also== {{div col~~-begin~~\|colwidth=28em}} * [[Brazilian Health Regulatory Agency]] {{col-2}}▼ * [[National Sanitary Surveillance Agency\|ANVISA, Brazil]] * [[Australia New Zealand Therapeutic Products Authority]] * [[Biotechnology Innovation Organization~~\|BIO~~]] * [[CIOMS Guidelines]] * [[Clinical study report]] * [[Clinical trial]] * [[Common Technical Document]] * [[Council for International Organizations of Medical Sciences]] * [[European Federation of Pharmaceutical Industries and Associations~~\|EFPIA~~]] * [[Food and Drug Administration\|~~FDA~~Food and Drug Administration, US]] * [[Good clinical practice]] (GCP) * [[Health ~~Canada\|Health Canada,~~ Canada]] * [[Health Sciences Authority\|HSA, Singapore]] * [[~~Japan~~International Federation of Pharmaceutical Manufacturers ~~Association\|JPMA~~& Associations]]▼ * ~~[[IFPMA]] – & –~~ [[International Pharmaceutical Federation]]▼ ~~{{col-2}}~~ * [[Japan Pharmaceutical Manufacturers Association]] ▲* [[IFPMA]] – & – [[International Pharmaceutical Federation]] * [[Ministry of Food and Drug Safety\|Ministry of Food and Drug Safety, Republic of Korea]] ▲* [[Japan Pharmaceutical Manufacturers Association\|JPMA]] * [[Ministry of ~~Food~~Health, Labour and ~~Drug Safety~~Welfare\|~~MFDS~~Ministry of Health, ~~Republic~~Labour ofand Welfare, ~~Korea~~Japan]] * [[Ministry of Health, Labour and Welfare\|MHLW, Japan]] * [[National pharmaceuticals policy]] * [[Pharmaceutical policy]] * [[Pharmacopoeia]] * [[Pharmaceutical Research and Manufacturers of America~~\|PhRMA~~]] * [[Pharmaceuticals and Medical Devices Agency\|~~PMDA~~Pharmaceuticals and Medical Devices Agency, Japan]] * [[Regulation of therapeutic goods]] * [[Swissmedic\|Swissmedic, Switzerland]] * [[Food and Drug Administration (Taiwan)~~\|TFDA, Taiwan~~]] * [[Uppsala Monitoring Centre]]{{div col end}} ~~{{col-end}}~~ ==Notes== Line 113 ⟶ 104: ==External links== {{div col~~-begin~~\|colwidth=28em}} ~~{{col-2}}~~ * [http://www.ich.org ICH website] * [http://theectdsummit.com/summit/?p=612 Analysis: New ICH M2 Requirements into eCTD NMV (=RPS)] * [http://portal.anvisa.gov.br/ ANVISA, Brazil] * [https://www.bio.org/ BIO] * [https://ec.europa.eu/health/human-use_en EC, Europe] * [https://www.efpia.eu/ EFPIA] * [https://www.fda.gov/ FDA, US] * [http://www.hc-sc.gc.ca/ Health Canada, Canada] * [http://www.hsa.gov.sg/ HSA, Singapore] * [http://www.igbamedicines.org/ IGBA] ▼ * [http://www.jpma.or.jp/ JPMA] ▼ ~~{{col-2}}~~ ▲* [http://www.igbamedicines.org/ IGBA] ▲* [http://www.jpma.or.jp/ JPMA] * [https://www.meddra.org/ MedDRA website] * [http://www.mfds.go.kr/ MFDS, Republic of Korea] * [http://www.mhlw.go.jp/ MHLW/PMDA, Japan] * [http://www.phrma.org/ PhRMA] * [https://www.swissmedic.ch/ Swissmedic, Switzerland] * [https://www.fda.gov.tw/ TFDA, Chinese Taipei] * [http://www.wsmi.org/ WSMI] ▲{{div col-2 end}} {{DEFAULTSORT:International Conference On Harmonisation Of Technical Requirements For Registration Of Pharmaceuticals For Human Use}} Line 141 ⟶ 130: [[Category:Drug safety]] [[Category:Life sciences industry]] [[Category:International standards]]