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ICH Institution Profile | Drug Discovery & DDS

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INSTITUTION PROFILE

ICH
— The forum that harmonizes how new medicines are tested and how applications are structured across countries

ICH (International Conference on Drug Regulatory Harmonics) is a collection of medical regulatory bodies and pharmaceutical organizations in each country. Testing and application materials necessary for the development of new drugstechnical requirementsInternational Organization ICH does not approve the drug, but here is the agreed guidelines by authorities such as the United States, Europe, Japan, and China. To incorporate the rules of your country,"Common Rules" for New Drug Development Planworks as In this article, ICHHow much does drug discovery and DDS affect?We will organize the main guidelines from the way they are imported.

Composition: ICH’s official website (list of members, history, page of each guideline and status of implementation, funding, announcement of the general meeting in June 2026) and the budget book for FY2026 as the primary information / final update September 2026

In this article
  1. ICH in 30 seconds
  2. What kind of organization is the type of influence?
  3. What is DDS?
  4. Scope of influence (authorization and region)
  5. Companies and organizations involved
  6. Future Prospects
  7. Glossary/Source/Ins ment and Source Response Table

1. ICH in 30 seconds

NameInternational Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human UseInternational Conference on Pharmaceutical Regulations
Country / RegionInternational Organization (S)zerland Law Association)Switzerland
Type of OrganizationRegulatory and industry associationsNo approval screening
Established in April 1990Incorporated on October 23, 2015
Number of peopleMember 25 observer 43as of June 2026. regulators out of 19
Budget (2026)1,850,000 Swiss francAbout 36 million of medical terminology MedDRA related costs
Involvement in drug discovery and DDSTechnical Guidelines AgreementNon-clinical/Clinical/Quality/Application Format
Impact rangeThe entire market of affiliatesBusinesses in other countries that want to sell in the market
1 point to press

ICH GuidelinesThere is no legal force in itself, and each authority has the first time to implement it as its own rulesHome ICH aims to implement all regulatory members’ guidelines, The implementation is carried out according to the rules of each country and region, and the time varies depending on the authorities. FactsHome However, there is a large influence on the main authorities such as the United States, Europe, Japan, and China. BusinessesApplication materials for the same test plan and common formatto apply for multiple markets.

2. What kind of organization is the type of influence?

The drug discovery and DDS articles are not sold by yourself. instead ofWhat pathways will affect the industry?is divided into four types.

4 types of drug discovery and DDS The institution does not sell the drug yourself. 4 different routes to influence the industry Funding Decide on policies and regulations Set the standard Make a place Budget for R&D Clinical Examination and Approval Harmonization of technical guidelines Presentation of clinical data NIH FDA／EMA／PMDA／NMPA ICH AACR／ASCO What to do What to Sell How to apply Who sees what data Scope to reach: budget of your country Scope of delivery = market of your country Scope to reach: affiliates Scope to reach: Participants ICH is centered on the standard type. The role of "place" where authorities and industry organizations discuss in the same table However, the force is born for the first time when the member authority adopts it as its own rules
Figure 1　4 types of drug discovery and DDS related organizations and ICH position. The classification is based on this article, and the name of the organization is shown by eight institutions in this series. Format of this paperHome ICH has both the “standard” type that agrees with the guidelines and the “place” type discussed by regulatory authorities and industry groups.

3. What is DDS?

ICH’s guidelines are divided into four categories: quality (Q), safety (S), effectiveness (E) and complex (M). We will arrange the day of adoption (Step 4) for 6 special drugs and DDSs, and the date of implementation as the rule of their country by the authorities in Europe and Japan. Facts。

GuidelineWhat to doAdoption (Step 4)European/US/Japan/ChinaAuthorities
M3(R2)Need to support clinical trials and approval applicationsNon-clinical Safety TestingTypes, Periods and PeriodsJune 11, 2009December 2009 / January 2010 / February 2010 / November 202119 authorities
S6(R1)BiopharmaceuPre)ical safety evaluation of antibodies. Evaluation of animal species, immunogenic, reproductive toxicity, and cancerJune 12, 2011December 2011 / May 2012 / March 2012 / May 202019 authorities
E9(R1)What to Estimate in Clinical TrialsEstimated target = estimandframework and sensitivity analysisNovember 20, 2019July 2020 / May 2021 / June 2024 / January 202119 authorities
Q5EBiopharmaceuEquality and homogeneity before and after changing the manufacturing processRatingNovember 18, 2004June 2005 / June 2005 / April 2005 / July 202019 authorities
Q6BBiopharmaceuStandards and Test Methods(Acceptance Standard)March 10, 1999September 1999 / August 1999 / May 200119 authorities
M4（CTD）Application for approvalCommon formatHome Only the first part of the five modules differs depending on the regionNovember 2000
M4(R4) June 15, 2016		Required: Europe and Japan 2003, USA 2017. China held in February 2018―

* The date and number of officials are based on the status of the implementation of the ICH Guidelines (19 regulatory members). As there is a difference between the European implementation of E9 (R1) and the implementation of Japan,The period from adoption to implementation differs greatly depending on the authorities。

Agenda in progress toward new modalities

AgendaHomeContact
S13Nucleic acidNon-Clinical Safety Test for OligonukreotideIn June 2023, the general meeting was approved and established a working group. Report on progress at the general meeting of June 2026
Q6(R1)Q6A and Q6B are revised simultaneously.All modalitiesPrinciples of standard settings common toIn June 2021, the general meeting was approved and the concept document was approved in July 2024.
Q5ECell and gene therapyAdvanced Medical Products (ATMP)The equivalent of the process changeApril 2025
M18BiosimilarFramework for determining how comparable efficacy testing is needed in developmentMay 2025
E23Real World EvidenceHow to use it for regulatory decisionsMay 2025
From the viewpoint of drug discovery: guidelines become a “design diagram of development plan”

M3(R2) specifies which non-clinical study should be expected at each stage of the clinical trial. Pre-clinical budgets and datesleft. In biopharmaceu s such as antibodies, S6(R1) can choose animal species, Q5E and Q6B decide manufacturing and quality control assembly. In relatively new modalities such as nucleic acid drugs, cell and gene therapy, a dedicated agreement (S13, Q5E Annex) is still working, There is a part to rely on individual consultations by authorities Undetermined / Future。

4. Scope of influence (authorization and region)

What ICH hasNot having
As an agreement between authorities and industry organizationsAdopt technical guidelinespermissions. Regulatory members aim to implement all guidelinesauthority to approve and dis drugs. authority to force guidelines directly to the company (force is born from the rules of each authority)
Region19 regulatory members (Europe, US, Japan, China, Canada, Switzerland, UK, Korea, Brazil, etc.) market. Ob Bar includes WHO, India, Australia and other authoritiesRegulations of non-member countries. Authorization to instruct the authorities during the implementation and method
All companies you want to sell in the market.Regardless of the country of head officeFollow the guidelines conducted by the relevant authoritiesMember of individual companies
SizeThe Swiss franc budget for 2026 was 1,850 million. The annual membership fee is 233,000 Swiss francA large permanent research and examination organization (work is carried by the authorities and industry experts)
Notes on reading numbers

In the 2026, about 13.8 million Swiss franc is the maintenance and operation cost of MedDRA, a medical glossary for regulation. MedDRAICH’s membership income is about 236 million Swiss francHome FactsHome The influence of ICH is not budget size,Main authorities have joined the same agreementHome In addition, "Member 25" was the number of organizations, and the number of experts involved in ICH's activities was not confirmed by the publication material. Undetermined / Future。

5. Companies and organizations involved

How the ICH Guidelines reach your company Agreed by authorities and industry bodies (Step 4) to implement their own rules (Step 5) Regulatory Member(19) EC/FDA/MHLW/PMDA/FDAPA Industry Group Members (6) EFPIA/JPMA/PhRMA/JP etc. Ob (43) WHO/IFPMA ICH Guideline Agreement and Adoption (Step 4) Example: When the S6 (R1) (pre ical safety of biopharmaceu s) was carried out by each authorities Europe (EC) December 2011 Japan(MHLW・PMDA) March 2012 USA (FDA) May 2012 China ()PA) May 2020 Pharmaceutical companies: can apply to each region in a common form (CTD) However, the time of implementation is different by the authorities, and the local documents (CTD part 1) remain.
Figure 2　ICH’s guidelines are agreed and flows to the company as the rules of each authority. Source: ICH member list, announcement of the general meeting in June 2026, implementation status of the safety guidelines page (S6 (R1)), page of CDD. 4 out of 6 groups and 3 out of 43 Format of this paper。

Member Breakdown

Member (based on ICH notation)Relationship with the Series
Founding MemberEC (Europe), FDA (US), MHLW/PMDA (Japan)FDA, FDA, PMDA Europe Joins EC, Europe
Founding MemberEFPIA、JPMA、PhRMAIndividual pharmaceutical companies participate through industry groups, not members
Regular and General Regulatory Members16 authorities including Health Canada, Swissmedic, PAPA (China), MHRA (UK), MFDS (South Korea), and ANVISA (Brazilian)NMPA
General Industry Group MembersBIO、Global Self-Care Federation、IGBAParticipation as a group rather than individual companies
Permanent ObIFPMA、WHORoutes to other countries

6. Future Prospects

ReadPrimary Information
Combination of non-clinical safety testing for nucleic acid drugs in Europe and JapanOne AgreementContact UsS13 was approved by the General Assembly in June 2023 and reported progress at the General Assembly in June 2026. The time of adoption and implementation of each authority is not determined
The concept of standard setting exceeds the distinction of chemical products and biopharmaceu sNew modalitiesCloseQ6(R1) aims to revise Q6A and Q6B simultaneously and create a common principle for all modalities
In the future, ICH’s agreed market will continueExpanded by members of the observerSome guidelines are required for observers to become regulators. In June 2026, two authorities joined the observer

7. Glossary

Step 4／Step 5
Stage of ICH procedure. In Step 4, the guidelines are finally adopted, and each authorities in Step 5.
CTD
Common format for approval application materials. The first part consists of local documents, and the second to fifth parts are general, quality, non-clinical, and clinical.
Estimated target (estimand)
In clinical trials, the idea of predetermining what effect is under what condition is in the patient population. E9(R1)
Comparability
Evaluation to indicate that there is no negative impact on quality, safety and efficacy even when changing the manufacturing method. Q5E sets the principle.
Ob
Authorities and organizations that can participate in ICH discussions but are not members. Some guidelines are required to migrate to regulatory members.

8. Source

  1. ICH　Members & Ob。s (a list of regulatory, industry, regulator, regulatory, industry, and observer) https://www.ich.org/page/members-observers
  2. ICH　History (3 classifications of quality, safety and effectiveness) https://www.ich.org/page/history
  3. ICH　Press Release: ICH Assembly Meeting, Rio de Janeiro, June 2026 (Participation 25・Observ 43, New Observ 2 Authority, S13・Q6(R1)・Q5E Appendix・M18・E23 etc progress) https://www.ich.org/pressrelease/press-release-ich-assembly-meeting-rio-de-janeiro-june-2026
  4. ICH　Guideline Members (Step 5 implementation, the goal for all regulatory members to implement all guidelines according to the rules of each country, starting from observer status to regulatory members). https://www.ich.org/page/ich-guideline-implementation
  5. ICH　Multidisciplinary Guidelines (M3(R2), date and status of Step 4, M18) https://www.ich.org/page/multidisciplinary-guidelines
  6. ICH　Safety Guidelines (S6(R1), Step 4 date and implementation status, S13) https://www.ich.org/page/safety-guidelines
  7. ICH　Efficacy Guidelines (E9(R1), date and status of Step 4, E23). https://www.ich.org/page/efficacy-guidelines
  8. ICH　Quality Guidelines (Q5E, Q6B, Step 4 date, implementation status, Q5E Annex, Q6 (R1)) https://www.ich.org/page/quality-guidelines
  9. ICH　CTD (5 modules, 2003 in Europe and Japan, 2017 in the United States, M4 (R4) Step 4 and status of implementation). https://www.ich.org/page/ctd
  10. ICH　2026 ICH & MedDRA。ed Budget Unit: thousand Swiss franc). https://admin.ich.org/sites/default/files/inline-files/2026%20ICH%20%26%20MedDRA%20Combined%20Budget.pdf
  11. ICH　2026 ICH Annual Membership Fees https://admin.ich.org/sites/default/files/inline-files/2026_ICH%20Membership%20Fee.pdf

9. Response table of claims and sources

Content
List of members and observers, breakdown of regulatory members 19 and industry members 6FactsSource 1 https://www.ich.org/page/members-observers
Inauguration of the Swiss Law on October 23, 2015FactsSource 2 https://www.ich.org/page/history
Member 25 observer 43 (June 2026), 2 new observer of the authorities, progress of the agenda in progressFactsSource 3 https://www.ich.org/pressrelease/press-release-ich-assembly-meeting-rio-de-janeiro-june-2026
Goals for all regulatory members, implementation according to the rules of each country, and membership conditions for observersFactsSource 4 https://www.ich.org/page/ich-guideline-implementation
Step 4 of M3 (R2), June 11, 2014, and 15 of 19 authorities in Europe and Japan.FactsSource 5 https://www.ich.org/page/multidisciplinary-guidelines
Step 4 of S6 (R1) (June 12, 2011) and 16 of 19 authorities were held in Japan and the U.S. and Europe, and the approval period of S13 wasFactsSource 6 https://www.ich.org/page/safety-guidelines
E9(R1)Step 4 (November 20, 2019) and EU-Japan implementation days, 13 of 19 authorities, and E23 approval timesFactsSource 7 https://www.ich.org/page/efficacy-guidelines
Q5E・Q6B Step 4 and status of implementation, Q5E Annex and Q6 (R1) content and approval timeFactsSource 8 https://www.ich.org/page/quality-guidelines
CTD’s 5 modules, Europe and Japan, 2003, USA, 2017, M4 (R4), Step 4, ChinaFactsSource 9 https://www.ich.org/page/ctd
2026 budget 1,849.7 million Swiss franc, MedDRA related 1,376.5 million, membership income 235.5 millionFactsSource10 https://admin.ich.org/sites/default/files/inline-files/2026%20ICH%20%26%20MedDRA%20Combined%20Budget.pdf
Founding Member’s annual membership fee 233,000 Swiss franc, Geneva OfficeFactsSource11 https://admin.ich.org/sites/default/files/inline-files/2026_ICH%20Membership%20Fee.pdf
Selection of six drug discovery and DDS, Figure 2 reportFormat of this paperThis article
The time of adoption of agreements for nucleic acid drugs and ATMP and the time of implementation of each authority, the number of experts involved in ICHUndetermined / FutureNot specified in the source 3, 6, and 8. This article does not estimate
Chapter 6 Prospects 3 ItemsInterpre of this paper from the source 3, 4, 6, and 8

Last Updated:September 26, 2026/Troy Technical
The figures and dates of this article are based on ICH’s official website and budget. The status of the guidelines may differ from the latest notifications of each authority. This is an interpretation that reads from primary information. This article is not medical advice.

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