The European Hematology Association (EHA)

European Affairs

Regulatory affairs & scientific relations

EHA’s regulatory work: European Medicines Agency

Most of EHA’s regulatory work entails collaboration with the European Medicines Agency (EMA). EMA is the European Union agency responsible for:

  • Evaluating the efficacy and safety of medicines submitted for EU marketing authorization
  • Monitoring safety across the lifecycle of medicines

We've built a strong, mutually beneficial relationship with EMA that encompasses:

  • The exchange of information and advice
  • Joint educational activities
  • The nomination of experts for regulatory assessment and scientific consultations

Our relationship also encourages dialogue between regulators and medical experts on a range of issues, including:

  • Emerging trends and issues arising from scientific and technological innovation
  • The implications of new EU legislation

EHA actively participates in several EMA groups and platforms, including the:

  • Health Care Professionals Working Party (HCPWP)
  • Policy Officers Group (HCP POG)
  • Cancer Medicines Forum
  • ACT EU Multi-stakeholder Platform Advisory Group (MSP AG)

We also interact and collaborate with relevant EMA expert teams and groups, such as:

  • Haematology Working Party (HaemWP)
  • Inter-Committee Scientific Advisory Group on Oncology
  • ATMPs & Haematology Office
  • Committee on Advanced Therapies (CAT)
  • Committee on Orphan Medicinal Products (COMP)

Read our monthly news and updates on EMA scientific committees' decisions and hematological medicines on the selected EMA news page.

Scientific relations

European Affairs closely interacts with EHA’s Specialized Working Groups (SWGs). This helps us effectively advocate for the interests of researchers and clinicians in the EU context, signal opportunities for collaboration, and support policymakers, regulators, and payers in need of the best available scientific advice.

Our role is to:

  • Facilitate direct involvement of experts in policy and regulatory processes
  • Monitor and alert members to funding opportunities for research
  • Link EMA and other regulatory or Health Technology Assessment (HTA) bodies with leading experts, to assist with assessments of medicines and therapies
  • Create, participate in, or support European scientific networks that are either hematology-specific or cross-disciplinary