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Identification of Medicinal Products & Pharmacovigilance Task Forces

Identification of Medicinal Products & Pharmacovigilance Task Forces. Outline. ICH Presentation of the work items Discussion. ICH. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH: Organisation. The six parties:.

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Identification of Medicinal Products & Pharmacovigilance Task Forces

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  1. Identification of Medicinal Products&PharmacovigilanceTask Forces ISO TC215 WG6 Brisbane

  2. Outline • ICH • Presentation of the work items • Discussion ISO TC215 WG6 Brisbane

  3. ICH International Conference on Harmonisationof Technical Requirements for Registration of Pharmaceuticals for Human Use ISO TC215 WG6 Brisbane

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

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

  7. 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 TC215 WG6 Brisbane

  8. 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 ISO TC215 WG6 Brisbane

  9. The Seven Work Items ISO TC215 WG6 Brisbane

  10. 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 informaticsIdentification of medicinal productsData elements and structures for the exchange of regulated product information for drug dictionaries N548 Health informaticsIdentification of medicinal productsStructures and controlled vocabularies for pharmaceutical product identifiers (PhPIDs) N549 Health informaticsIdentification of medicinal productsStructures and controlled vocabulary for ingredients N550 Health informaticsIdentification of medicinal productsStructures and controlled vocabulary for pharmaceutical dose forms N550 Health informaticsIdentification of medicinal productsStructures and controlled vocabulary for units of presentation N551 Health informaticsIdentification of medicinal products Structures and controlled vocabulary for units of measurement N550 Health informaticsIdentification of medicinal productsStructures and controlled vocabulary for routes of administration ISO TC215 WG6 Brisbane

  11. Thank you ISO TC215 WG6 Brisbane

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