Work plan for the joint CHMP/CVMP Quality Working Party (QMP) for 2018

On December 4, 2017, the CHMP/CVMP Working Party issued their final work plan for the joint Quality Working Party (QWP) for 2018 The Plan outlines the agreed upon business priorities and the Agency’s relocation because of the United Kingdom’s exit from the European Union and the resulting impact on the Agency’s business continuity.  Business covered:

  • 1. Meetings scheduled for 2018
  • 2. EU Guidelines and Reflection Papers
    •  2.1New EU Guidelines and Reflection Papers
    • 2.2 EU Guidance under revision
    • 2.3(V)ICH Guidelines
  • 3. Medicinal Products-specific activities
    • 3.1 Pre-Authorisation activities
    • 3.2 Evaluation and supervision activities
  • 4. Input in European activities
    • 4.1 Training for the Network and Knowledge Building
  • 5. Input in International activities (beyond ICH guidelines)
    • 5.1 Activities with other regulators
    • 5.2 Activities with international bodies
  • 6. Contribution to dialogue and engagement with stakeholders and external parties

In addition to the actions identified above, the working party can be involved in any other activities foreseen in its mandate: Click Here

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