Identification of Medicinal Products

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Identification of Medicinal ProductsPharmacovig
ilanceTask Forces
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Outline

• ICH
• Presentation of the work items
• Discussion

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ICH

• International Conference on Harmonisationof
• Technical Requirements for Registration
• of Pharmaceuticals for Human Use

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ICH Organisation
The six parties
Regulators EC (EU), MHLW (JP), FDA
(US) Industry EFPIA, JPMA, PhRMA
Secretariat
IFPMA
Observers
EFTA, Health Canada, WHO
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ICH Terms of Reference

• To maintain a forum for a constructive dialogue
  between regulatory authorities and the
  pharmaceutical industry on the real and perceived
  differences in the technical requirements for
  product registration in the EU, USA and Japan in
  order to ensure a more timely introduction of new
  medicinal products, and their availability to
  patients 
• To contribute to the protection of public health
  from an international perspective (added upon
  revision in 2000) 
• To monitor and update harmonised technical
  requirements leading to a greater mutual
  acceptance of research and development data 
• To avoid divergent future requirements through
  harmonisation of selected topics needed as a
  result of therapeutic advances and the
  development of new technologies for the
  production of medicinal products 
• To facilitate the adoption of new or improved
  technical research and development approaches
  which update or replace current practices, where
  these permit a more economical use of human,
  animal and material resources, without
  compromising safety 
• To facilitate the dissemination and communication
  of information on harmonised guidelines and their
  use such as to encourage the implementation and
  integration of common standards

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ICH Products
Quality Safety Efficacy Multidisciplinary
23 Guidelines 13 Guidelines 18 Guidelines 6
Guidelines/Specifications
All available at
www.ich.org
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Summary

• ICH exists to promote harmonisation in the area
  of the regulation of pharmaceuticals
• To help ensure timely registration of new
  products through harmonisation of technical
  content
• To minimise duplication of work
• In order to improve the process of electronic
  standards development and ensure their
  applicability in the ICH regions, ICH is piloting
  its SDO Process
• The aim of the SDO Process is to develop
  standards that are accredited by ISO, CEN and HL7
  and implemented through ICH.

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ISO, CEN, HL7 ICH

• For legal and practical reasons, standards that
  ICH proposes for development need to be
  recognised by ISO, CEN and HL7
• At the time that ICH became a liaison member of
  ISO, ISO, CEN and HL7 were already in discussions
  regarding the Joint Initiative, the Charter for
  which was announced at the TC215 Plenary meeting
  in Montreal

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The Seven Work Items
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N546 Health informatics Pharmacovigilance
Structures and controlled vocabulary for
laboratory test units for the reporting of
laboratory results
N545 Health informatics Pharmacovigilance
Individual case safety report
N 547 Health informatics Identification of
medicinal productsData elements and structures
for the exchange of regulated product
information for drug dictionaries

N548 Health informatics Identification of
medicinal products Structures and controlled
vocabularies for pharmaceutical product
identifiers (PhPIDs)
N549 Health informatics Identification of
medicinal products Structures and controlled
vocabulary for ingredients
N550 Health informatics Identification of
medicinal products Structures and controlled
vocabulary for pharmaceutical dose forms
N550 Health informatics Identification of
medicinal products Structures and controlled
vocabulary for units of presentation
N551 Health informatics Identification of
medicinal products Structures and controlled
vocabulary for units of measurement
N550 Health informatics Identification of
medicinal products Structures and controlled
vocabulary for routes of administration
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Thank you