1. 17 September 2007ISO TC215 WG6 Brisbane1 Identification of Medicinal Products & Pharmacovigilance Task Forces

2. 17 September 2007ISO TC215 WG6 Brisbane2 Outline ICH Presentation of the work items Discussion

3. 17 September 2007ISO TC215 WG6 Brisbane3 ICH International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use

4. 17 September 2007ISO TC215 WG6 Brisbane4 ICH: Organisation The six parties: Regulators : EC (EU), MHLW (JP), FDA (US) Industry: EFPIA, JPMA, PhRMA Secretariat: IFPMA Observers: EFTA, Health Canada, WHO

5. 17 September 2007ISO TC215 WG6 Brisbane5 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

6. 17 September 2007ISO TC215 WG6 Brisbane6 ICH Products Quality Safety Efficacy Multidisciplinary 23 Guidelines 13 Guidelines 18 Guidelines 6 Guidelines/Specifications All available at www.ich.org

7. 17 September 2007ISO TC215 WG6 Brisbane7 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.

8. 17 September 2007ISO TC215 WG6 Brisbane8 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

9. 17 September 2007ISO TC215 WG6 Brisbane9 The Seven Work Items

10. 17 September 2007ISO TC215 WG6 Brisbane10 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) 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

11. 17 September 2007ISO TC215 WG6 Brisbane11 Thank you