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International Conference On Harmonisation (ICH)

The document discusses the International Conference on Harmonisation (ICH), which aims to harmonize technical requirements for pharmaceutical product registration. It lists the permanent and standing regulatory members as well as regulatory and industry members. It also lists 23 observer organizations. It defines the Common Technical Document (CTD) format and electronic CTD (eCTD) format, noting the benefits of eCTD include improved data quality, reusability, and access, as well as lifecycle management. However, challenges in adopting eCTD include limited knowledge, software/IT issues, transition plans, communication of requirements, and managing new specifications.

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71 views7 pages

International Conference On Harmonisation (ICH)

The document discusses the International Conference on Harmonisation (ICH), which aims to harmonize technical requirements for pharmaceutical product registration. It lists the permanent and standing regulatory members as well as regulatory and industry members. It also lists 23 observer organizations. It defines the Common Technical Document (CTD) format and electronic CTD (eCTD) format, noting the benefits of eCTD include improved data quality, reusability, and access, as well as lifecycle management. However, challenges in adopting eCTD include limited knowledge, software/IT issues, transition plans, communication of requirements, and managing new specifications.

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International Conference on Harmonisation (ICH)

ICH Members
 Permanent Members:
 Founding regulatory members: EC, Europe; MHLW/PMDA, Japan; FDA, US

 Founding industry members: EFPIA, JPMA, PhRMA

 Standing Regulatory Members:


 Health Canada, Canada; Swissmedic, Switzerland

 Regulatory Members:
 ANVISA, Brazil; CFDA, China; MFDS, Republic of Korea

 Industy Members:
 BIO; IGBA; WSMI

ICH Observers
 23 Observers:
 Including Roszrdravnadzor, Russia; IFPMA, WHO, TGA, Australia; EDQM, EU; APEC, ASEAN;

http://www.ich.org/
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CTD Definition

 The Common Technical Document (CTD) defines the


organisation of a paper submission that is accepted by
regulatory authorities in scope

 ICH Multidisciplinary Expert Working Group (M4 EWG) defines


CTD

 Out of scope: Guidelines for local (national/regional) content


requirements

9
eCTD Definition

 The electronic Common Technical Document (eCTD) is the


electronic presentation of the CTD. It is a standard format for
text, data, and images and facilitates electronic transmission of
information from transmitter to receiver.

 ICH M8 Multidisciplinary Expert Working Group


(EWG)/Implementation Working Group (IWG) defines eCTD
format and specifications to manage common documentation
 Current eCTD is v3.2.2
 Next version of eCTD is v4.0 (global adoption from 2020 onwards)

 Out of Scope: Guidelines for regional requirements

1 0
Before eCTD

CTD dossier in bookrack Reviewer‘s desk

11
After eCTD

eCTD is a standard format for


exchange of data and metadata

Industry - gateway/portal - Agency

eCTD dossier in server Reviewer‘s desk

12
Benefits of eCTD

 Expectation was:
 High availability
 Easy view / navigation
 Fast retrieval
 Lifecycle support
 Replaces paper
 Results are:
 Expected advantages have been met
 Contribute to improvement of:
 Data quality
 Reusability
 Faster and secure access to dossiers via gateway or portal
 Lifecycle management

13
Challenges with eCTD

 eCTD adoption has provided Health Authorities and


Industry with challenges;
 Limited knowledge to its adoption that impacts uptake
 Software / IT infrastructure / Interoperability
 Transition plans for new and registered products
 Clear communication and interpretation of requirements
 Management and implementation of new specifications

14

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