17 september 2007iso tc215 wg6 brisbane1 identification of medicinal products &...

17 September 2007 ISO TC215 WG6 Brisbane 1

Identification of Medicinal Products&

Pharmacovigilance

Task Forces


Outline

• ICH

• Presentation of the work items

• Discussion


ICH

International Conference on Harmonisationof

Technical Requirements for Registration

of Pharmaceuticals for Human Use


ICH: Organisation

The six parties:

Regulators : EC (EU), MHLW (JP), FDA (US)

Industry: EFPIA, JPMA, PhRMA

Secretariat:

IFPMA

Observers:

EFTA, Health Canada, WHO


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


ICH Products

Quality

Safety

Efficacy

Multidisciplinary

23 Guidelines

13 Guidelines

18 Guidelines

6 Guidelines/Specifications

All available at

www.ich.org


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.


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


The Seven Work Items


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)


Structures and controlled vocabularies for pharmaceutical product identifiers (PhPIDs)


Structures and controlled vocabulary for ingredients


Structures and controlled vocabulary for ingredients

N551 Health informatics Identification of medicinal products Structures and controlled vocabulary

for units of measurement


for units of measurement


Structures and controlled vocabulary for units of presentation


Structures and controlled vocabulary for units of presentation


Structures and controlled vocabulary for pharmaceutical dose forms


Structures and controlled vocabulary for pharmaceutical dose forms


for routes of administration


for routes of administration

N546 Health informatics Pharmacovigilance

Structures and controlled vocabulary for laboratory test units for the reporting of laboratory results


Structures and controlled vocabulary for laboratory test units for the reporting of laboratory results


Individual case safety report


Thank you

17 september 2007iso tc215 wg6 brisbane1 identification of medicinal products &...

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