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International Council on
Harmonisation of Technical
Requirements for
Registration of Pharmaceuticals for
Human Use (ICH) Overview
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History
 The birth of ICH took place at a meeting in April 1990, hosted by
EFPIA (European Federation of Pharmaceutical Industries and
Associations) in Brussels.
 Unique harmonisation initiative for regulators and pharmaceutical
industry
 Reformed as a non-profit legal entity under Swiss Law on October
23, 2015.
 First Decade: Development of guidelines of Safety, Quality and
Efficacy topics. Multidisciplinary topics, which included MedDRA
(Medical Dictionary for Regulatory Activities) and the CTD
(Common Technical Document) were also initiated.
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History
 Second decade: Facilitating the implementation of ICH Guidelines
in ICH's own regions and maintaining already existing ICH
Guidelines as science and technology continued to evolve.
 Third decade: Extended the benefits of harmonisation beyond the
founding ICH regions. Increasing international outreach; changing
ICH’s governance structure; disseminating more information on ICH
processes to a wider number of stakeholders; and establishing ICH as
a legal entity to provide for a more stable operating structure.
 Official Website: www.ich.org
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Mission
 To make recommendations towards achieving greater harmonisation
in the interpretation and application of technical Guidelines and
requirements for pharmaceutical product registration.
 To maintain a forum for a constructive dialogue on scientific issues
between regulatory authorities and the pharmaceutical industry.
 To contribute to the protection of public health in the interest of
patients from an international perspective.
 To monitor and update harmonised technical requirements.
 To facilitate the adoption of new or improved technical research and
development approaches which update or replace current practices.
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Purpose of ICH
Promotion of public health through international harmonisation that
contributes to:
 Prevention of unnecessary duplication of clinical trials and post
market clinical evaluations
 Development and manufacturing of new medicines
 Registration and supervision of new medicines
 Reduction of unnecessary animal testing without compromising
safety and effectiveness
Accomplished through Technical Guidelines that are implemented by
the regulatory authorities.
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Governance of ICH Association

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Governance of ICH Association

Assembly is:
 The main body of the Association, composed of all Members that take
decisions, regarding Articles of Association, Rules of Procedures,
admission of new Members, Adoption of ICH Guidelines, etc.
 ICH Assembly Chair: Ms. Lenita Lindström-Gommers (EC, Europe)
Management Committee is:
 The body that oversees operational aspects of the Association on
behalf of all Members, including administrative and financial matters
and oversight of the WGs.
 ICH Management Committee Chair: Dr. Theresa Mullin (FDA,
US)
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Governance of ICH Association

MedDRA Management Committee
 The MedDRA Management Committee (MC) has responsibility for
direction of MedDRA, an ICH standardised dictionary of medical
terminology.
Secretariat
 Day-to day management of ICH.
 coordinating ICH activities as well as providing support to the
Assembly, the ICH Management Committee and its Working Groups
 Support for the ICH MedDRA Management Committee
 Secretariat is located in Geneva, Switzerland.
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Governance of ICH Association

Working Groups
An ICH Working Group (WG) is established for each technical topic selected for
harmonisation.
 There are several different types of ICH working group:
 Expert Working Group (EWG): Develops harmonised guideline that meets the
objectives in the Concept Paper and Business Plan.
 Implementation Working Group: Develops Q&As to facilitate implementation of
existing guidelines.
 Informal Working Group: Is formed prior to any official ICH harmonisation
activity with the objectives of developing/finalising a Concept Paper, as well as
developing a Business Plan.
 Discussion Group: Discusses specific scientific considerations or views i.e. Gene
Therapy Discussion Group (GTDG), and ICH & Women Discussion Group.
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Governance of ICH Association

ICH Coordinators
 Ensure proper distribution of ICH documents to the appropriate persons
from their organisation.
 Responsible for the follow up on actions within their respective
organisation within assigned deadlines.
 Assist communication between the ICH Management Committee and/or
Assembly and the ICH Working Groups.
Auditors
 Audit the financial statements of the Association upon conclusion of each
Fiscal Year
 Appointed for a period of two years and may be re-appointed
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Members of ICH Committee

Founding Regulatory Members Swissmedic, Switzerland
EC, Europe (European Regulatory Members
Commission) ANVISA, Brazil (Agência
FDA, US (Food and Drug Nacional de Vigilância Sanitária)
Administration) CFDA, China (China Food and
MHLW/PMDA, Japan (Ministry of Drug Administration)
Health, Labor and Welfare of HSA, Singapore (Health Sciences
Japan/ Pharmaceuticals and Authority)
Medical Devices Agency) MFDS, Korea (ministry of Food
Founding Industry Members and Drug Safety)
EFPIA (European Federation of Industry Members
Pharmaceutical Industries and BIO (Biotechnology Innovation
Association) Organisation)
JPMA (Japan Pharmaceutical IGBA (International Generic and
Manufacturers Association Biosimilar Medicines Association)
PhRMA (Pharmaceutical Research WSMI (World Self-Medication
and Manufacturers of America) Industry)
Standing Regulatory Members
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Legislative or Administrative
Observers of ICH Committee
Authorities, Regional
Harmonisation Initiatives (RHIs),
International Pharmaceutical
Industry Organisation,
International Organisation
regulated or affected by ICH
Guideline

Latest addition to the Observers

list is
“Bill and Melinda Gates
Foundation”
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Work Products of ICH

Quality Guidelines
 Conduct of stability studies, defining relevant thresholds for
impurities testing and a more flexible approach to pharmaceutical
quality based on Good Manufacturing Practice (GMP) risk
management.
Safety Guidelines
 Uncovers potential risks like carcinogenicity, genotoxicity and
reprotoxicity.
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Work Products of ICH

Efficacy Guidelines
 The design, conduct, safety and reporting of clinical trials.
 Covers novel types of medicines derived from biotechnological
processes and the use of pharmacogenetics/ genomics techniques to
produce better targeted medicines.
Multidisciplinary Guidelines
 Includes the ICH medical terminology (MedDRA),
 Common Technical Document (CTD) and
 Development of Electronic Standards for the Transfer of Regulatory
Information (ESTRI).
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Work Products of ICH

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Work Products of ICH

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Work Products of ICH

electronic Common Technical Document (eCTD)
Medical Dictionary for Regulatory Activities (MedDRA):
 An ICH Standardised dictionary of medical terminology.
Consideration Documents:
 The Consideration documents have been developed by discussion
groups i.e., Gene Therapy Discussion Group, and ICH & Women
Discussion Group to report specific scientific considerations.
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Process of Harmonisation
The ICH SC is responsible for the governance of ICH.
 Each harmonisation activity is initiated by a Concept Paper which is
a short summary of the proposal.
 Depending on the category of harmonisation activity a Business Plan
may also be required.
 ICH harmonisation activities fall into 4 categories:
 Formal ICH Procedure,
 Q&A Procedure,
 Revision Procedure and
 Maintenance Procedure.
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Process of Harmonisation
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Formal ICH Procedure

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Formal ICH Procedure

 The process of consensus building begins when the ICH SC adopts a
Concept Paper as a new topic.
 Step 1 is initiated when the EWG begins the preparation of a
consensus draft of the technical document, based on the objectives
set out in the Concept Paper.
 Work is conducted via e-mail, teleconferences and web conferences.
If endorsed by the SC, the EWG will also meet face-to-face at the
biannual SC meetings.
 Interim reports on the progress of the draft technical document are
made to the SC on a regular basis.
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Formal ICH Procedure

 When consensus is reached among EWG members from all ICH
Parties, the EWG will sign the Step 1 Experts sign-off sheet.
 The Step 1 Technical Document with EWG signatures is then
submitted to the ICH SC to request adoption under Step 2a of the
ICH process.
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Formal ICH Procedure

 Step 2a (Confirmation of consensus on the Technical Document:)
is reached when the ICH SC agrees based on the report of the EWG,
that there is sufficient scientific consensus on the technical issues for
the Technical Document to proceed to the next stage of regulatory
consultation.
 The consensus text approved by the experts under Step 1 is signed-
off by the SC as the Step 2a Final Technical Document.
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Formal ICH Procedure

Step 2b: Adoption of the draft Guideline:
 On the basis of the technical document, the Regulatory ICH Parties
will take the actions they deem necessary to develop the “draft
Guideline”.
 The consensus text is signed-off by the SC Regulatory ICH Parties as
Step 2b Draft Guideline.
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Formal ICH Procedure

Step 3 occurs in three distinct stages:
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. In the EU it is published as a draft
CHMP Guideline, in Japan it is translated and issued by MHLW for
internal and external consultation, in the USA it is published as draft
guidance in the Federal Register and in Canada it is posted on the
Health Canada website to solicit comments.
Regulatory authorities and industry associations in other regions may
also comment on the draft consultation documents by providing their
comments to the ICH Secretariat.
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Formal ICH Procedure

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.
 If the Rapporteur was from an industry party, until Step 2b a new
Rapporteur from a regulatory party is appointed, preferably from the
same region as the previous Rapporteur.
 The same procedure described in Step 1 is used to address the
consultation results.
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Formal ICH Procedure

Stage III: Finalisation of Step 3 Experts Draft Guideline:
 When, after due consideration of the consultation results by the
EWG, consensus is reached amongst the experts from the ICH
Parties on a revised version of the Guideline, the Step 3 Experts
Draft Guideline is signed by the EWG experts of the Regulatory ICH
Parties.
 The Step 3 document with regulatory EWG signatures is submitted
to the SC to request adoption at Step 4 of the ICH process.
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Formal ICH Procedure

 Step 4 is reached when the ICH SC agrees, on the basis of the report
from the Regulatory Chair and the Rapporteur of the EWG, that
there is sufficient consensus on the draft guideline.
 Step 4 is reached when the document is signed-off by the SC
Regulatory ICH Parties as an ICH harmonised Guideline.
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Formal ICH Procedure

 Having reached Step 4, the harmonised Guideline moves
immediately to the final step of the process that is the regulatory
implementation or Step 5.
 Step 5 is carried out according to the same national/regional
procedures that apply to other regional regulatory guidelines and
requirements, in the EU, Japan, USA, Canada and Switzerland.
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Q & As Procedure
 The Q&As procedure is followed when additional guidance is
considered necessary to help the interpretation of certain ICH
harmonised Guidelines and ensure a smooth and consistent
implementation in the ICH regions and beyond.
 The procedure is initiated with the endorsement by the SC of a
Concept Paper (a Business Plan may be required in certain cases).
 An IWG is nominated to work on a draft Q&A document. The group
makes a recommendation to the SC on whether the document would
require a public consultation (Step 3 of the ICH process) based on
the level of information provided by the answers.
 The document then follows the normal path of a Step 2b/Step 4
document as per the Formal ICH Procedure.
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Revision Procedure
 The revision procedure is followed either in cases where the
scientific/technical content of an existing ICH Guideline is no longer
up-to-date or valid, or in cases where there is new information to be
added with no amendments to the existing ICH Guideline necessary.
 In the case of the latter, the new information can be added in the
form of an Addendum (or an Annex in the case of Q4B) to the
Guideline.
 The procedure is initiated with the endorsement by the SC of a
Concept Paper. For revisions a Business Plan is not necessary.
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Revision Procedure
 An EWG with membership as specified by the Concept Paper is
subsequently established.
 The revision procedure is almost identical to the Formal ICH
Procedure i.e. 5 ICH Steps. The only difference is that the final
outcome is a revised version of an existing Guideline, rather than a
new Guideline.
 The revision of a Guideline is designated by the letter R1 after the
usual denomination of the Guideline. When a Guideline is revised
more than once, the document will be named R2, R3, R4, etc at each
new revision. In cases where an Addendum has been developed,
upon reaching Step 4 the Addendum is added to the existing
Guideline.
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Maintenance Procedure
 The Maintenance Procedure is currently applicable only for changes
to the Q3C Guideline on Impurities: Residual Solvents and M2
Recommendations.
 In each case the procedure is used when there is new information to
be added or the scientific/ technical content is out-of-date or no
longer valid.
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Thank You for

your Kind Attention!!
Focus is only getting when the Body, Mind and Soul come together