On December 14, 2017, the EMA published its adopted Work Plan for the Biologics Working Party 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
    • 2.1 New EU Guidelines
    • 2.2 EU Guidance under revision
    • 2.3 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
    • 4.2 Support to and cooperation with EU institutions and Network
  5. Input in International activities (beyond ICH guidelines)
    • 5.1 Activities with other regulators
  6. Contribution to dialogue and engagement with stakeholders and external parties
    • 6.1 Workshops
    • 6.2 Other activities 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

Click Here to Open Official Publication