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Overview of ICHNovember 2020International Council for Harmonisation of Technical Requirementsfor Pharmaceuticals for Human Use
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ICHINTERNATIONAL COUNCIL FOR HARMONISATIONofTechnical Requirementsfor Pharmaceuticals for Human Use Unique harmonisation initiative for regulators andpharmaceutical industry Originally founded in 1990 Reformed as a non-profit legal entity under Swiss Law on 23October 20153
Purpose of ICHPromotion of public health through internationalharmonisation that contributes to: Prevention of unnecessary duplication of clinical trials andpost market clinical evaluations Development and manufacturing of new medicines Registration and supervision of new medicines Reduction of unnecessary animal testing withoutcompromising safety and effectivenessAccomplished through Technical Guidelines that areimplemented by the regulatory authorities.4
ICH Members(as of November 2020)17 Members: Founding Regulatory: EC, Europe; MHLW/PMDA, Japan; FDA, United StatesFounding Industry: EFPIA; JPMA; PhRMAStanding Regulatory: Swissmedic, Switzerland; Health Canada, CanadaRegulatory: ANVISA, Brazil; NMPA, China; HSA, Singapore; MFDS,Republic of Korea; TFDA, Chinese Taipei; TITCK, TurkeyIndustry: BIO; Global Self-Care Federation; IGBASee https://www.ich.org/page/members-observers for details
ICH Observers(as of November 2020)2 Standing Observers: WHO; IFPMA32 Observers: Regulatory authorities; Regional HarmonisationInitiatives; international industrypharmaceutical organisations; internationalorganisations regulated or affected by ICHGuidelinesSee https://www.ich.org/page/members-observers for details
Composition of ICH WGs742 experts in 33 WGs – as of November 2020
ICH Successes (1)GCP (Good Clinical Practice)Clinical trials conducted in one ICH region can be used in otherICH regions by setting the common standards on science andethics.8
ICH Successes (2)CTD/eCTD (Common Technical Document)ICHGuidelinesCTDeCTDReviewReviewCTD brings together all Quality, Safety and Efficacy informationin a common, harmonised format, accepted by regulators in allICH regions. It has revolutionised regulatory review processesfor regulators and industry.9
ICH Successes (3)MedDRA (Medical Dictionary for Regulatory Activities) Highly specific, standardised medical terminology developed byICH to facilitate sharing of regulatory information It is used for registration, documentation and safety monitoringof medical products both before and after marketingauthorisation10
ICH Products (as of November 2020)Close to 70 Guidelines on technical requirements on: Safety – 15 Guidelines Quality - 24 Guidelines Efficacy – 21 Guidelines Multidisciplinary - 7 GuidelinesElectronic Standards for the Transfer of RegulatoryInformation (ESTRI)CTD/eCTDMedDRA (standardised medical terminology)See http://www.ich.org/products/guidelines.html for details11
Structure of the ICH Association12
Remit of the Assemblyand the Management CommitteeAssembly is: The overarching body of the Association, composed of allMembers that take decisions, regarding Articles ofAssociation, Rules of Procedures, admission of newMembers, Adoption of ICH Guidelines, etc.Management Committee is: The body that oversees operational aspects of theAssociation on behalf of all Members, includingadministrative and financial matters and oversight of theWGs.13
Decision-making for ICH Guidelines The Management Committee provides: Recommendations on the selection of new topics forharmonisation as well as on the adoption, withdrawal oramendments of ICH Guidelines The Assembly takes decisions: By consensusIn the absence of consensus: vote in accordance with theArticles of Association, where only regulatory members havethe right to vote14
Membership in the Assembly—Eligibility Criteria for RegulatorsEngagement in the ICH Process Past regular attendance in ICH meetings Past appointment of experts in WGsApplication of ICH Guidelines Have implemented at least the following ICH Guidelines(“Tier 1”): Q1: Stability Testing Guidelines Q7: Good Manufacturing Practice Guide for ActivePharmaceutical Ingredients E6: Good Clinical Practice GuidelineSee https://www.ich.org/page/application-process for details15
Membership in the Assembly—Eligibility Criteria for IndustryType of Organisation International pharmaceutical industry organisationEngagement in the ICH Process Past regular attendance in ICH meetings Past appointment of experts in WGsImpact of ICH Guidelines The organisation and/or its members must be regulatedor affected by ICH guidelinesSee https://www.ich.org/page/application-process for details16
ICH Observers Limited eligibility criteria for new Observers Rights of Observers: To attend ICH Assembly meetings, but no right to voteor automatically appoint experts in WGs Standing Observers (WHO and IFPMA) maintain theirright to appoint experts in WGs No duties are imposed on ObserversSee https://www.ich.org/page/application-process for details17
Steps in the ICH Process forGuideline DevelopmentAdoption byRegulatorsSign-off byRegulatoryTopic LeadersEndorsementa. by Assemblyb. By RegulatorsSign-offby ocedure18
The ICH Step Process (1) Step 1:oThe WG works to prepare a consensus draft of the technicaldocument. Step2: Step 2a:oThe Members of the ICH Assembly are invited to endorse thetechnical document. Step 2b:oThe Regulatory Members of the ICH Assembly are invited toendorse the draft Guideline.19
The ICH Step Process (2) Step 3:ooPublic consultation by the ICH Regulatory Members and ICHSecretariat. All comments are considered by the WG.Step 3 is finalised once consensus is reached by the regulatoryexperts of the WG. Step 4:oThe Regulatory Members of the ICH Assembly adopt thefinal ICH harmonised Guideline. Step 5:oImplementation by the ICH Regulatory Members.20
Keys to ICH Success Involves expertise from both regulatory authorities andregulated industry Science-based, consensus driven Clear and effectively managed process Close collaboration of parties with comparable regulatoryand technical capability Commitment of regulators to implement products ofharmonisation Common global platform and tools Revised processes and governance21
Summary ICH has achieved international harmonisation oftechnical guidelines, withregulators and industry.engagementof ICH has clear governance and increasingly globalmembership following ICH reform. Five transparent steps in the ICH process forGuideline development.22
Thank you for your attentionwww.ich.orgVisit our websites for more information onthe work of ICH:www.ich.orgwww.meddra.orgFollow us on@ICH news23
Engagement in the ICH Process Past regular attendance in ICH meetings Past appointment of experts in WGs Application of ICH Guidelines Have implemented at least the following ICH Guidelines (“Tier 1”): Q1: Stability T
