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An agency of the european UnionAlberto Ganan Jimenez, PhD Quality of Medicines, european Medicines Agency (EMA)ICH and eu regulatory framework and the role of the european Medicines Agency (EMA)ASEAN Training Workshop on ICH Q5C30-31 May 2011, Kuala Lumpur2 Outline Overview ICH and the Global Cooperation Group european Medicines Agency (EMA) european Regulation of Medicinal Products Procedural Aspects (Centralised Procedure)3 To provide a brief overview of ICH Explain the role of the Steering Committee Responsibilities Membership Function Report on the mandate of the Global Cooperation Group Shift from information-sharing to training Membership (RHIs*, DRAs*)Agenda: International Conference on Harmonisation (ICH)*RHI: Regional Harmonisation Initiatives*DRA: Drug regulatory Authority4 ICHINTERNATIONAL CONFERENCE ONHARMONIS/ZATIONof Technical Requirements for the Registration of Pharmaceuticals for Human by ICH SecretariatIFPMA, Geneva, Switzerland5 ICH BackgroundUnique harmonisation project involving the regulators and research-based industries of US, EU and Japan started in 1990 WHO, Canada, and EFTA* are observersObjectives: to improve efficiency of new drug development and registra
Alberto Ganan Jimenez, PhD –Quality of Medicines, European Medicines Agency (EMA) An agency of the European Union ICH and EU regulatory framework and the role …
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