17 september 2007iso tc215 wg6 brisbane1 identification of medicinal products &...
TRANSCRIPT
17 September 2007 ISO TC215 WG6 Brisbane 1
Identification of Medicinal Products&
Pharmacovigilance
Task Forces
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Outline
• ICH
• Presentation of the work items
• Discussion
17 September 2007 ISO TC215 WG6 Brisbane 3
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
17 September 2007 ISO TC215 WG6 Brisbane 5
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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N 547 Health informatics Identification of medicinal products
Data elements and structures for the exchange of regulated product
information for drug dictionaries
N 547 Health informatics Identification of medicinal products
Data 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)
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
N549 Health informatics Identification of medicinal products
Structures and controlled vocabulary for ingredients
N551 Health informatics Identification of medicinal products Structures and controlled vocabulary
for units of measurement
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 units of presentation
N550 Health informatics Identification of medicinal products
Structures and controlled vocabulary for units of presentation
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 pharmaceutical dose forms
N550 Health informatics Identification of medicinal products Structures and controlled vocabulary
for routes of administration
N550 Health informatics Identification of medicinal products Structures and controlled vocabulary
for routes of administration
N546 Health informatics Pharmacovigilance
Structures and controlled vocabulary for laboratory test units for the reporting of laboratory results
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
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Thank you