Consultations
This website provides hospital pharmacists with information on open consultations that are being conducted by EAHP, the European Medicines Agency, the European Commission and any other entities or individuals.
EAHP
No open consultation at the moment.
European Commission
| Due date | Name of consultation | Scope of consultation |
| 04/10/2023 | Revision of the EU general pharmaceuticals legislation - Commission proposal | The proposal is open for feedback for a period of 8 week(s). All feedback received will be summarised by the European Commission and presented to the European Parliament and Council with the aim of feeding into the legislative debate. |
European Medicines Agency (EMA)
| Due date | Name of consultation | Scope of consultation |
| 26/09/2023 | Draft ICH E6 (R3) guideline on good clinical practice – step 2b | The objective of this ICH GCP Guideline is to provide a unified standard to facilitate the mutual acceptance of clinical trial data for ICH member countries and regions by applicable regulatory authorities. This guideline builds on key concepts outlined in ICH E8(R1) General Considerations for Clinical Studies. This includes fostering a quality culture and proactively designing quality into clinical trials and drug development planning, identifying factors critical to trial quality, and engaging stakeholders, as appropriate, using a proportionate risk-based approach. |
| 30/09/2023 | ICH Reflection paper on proposed international harmonisation of real-world evidence terminology and convergence of general principles regarding planning and reporting of studies using real-world data, with a focus on effectiveness of medicines | The objectives of this reflection paper are to engage ICH on convergence of terminology for real-world data and real-world evidence, on the format for protocols and reports of study results submitted to regulatory agencies throughout the lifecycle of medicinal products, and on promoting registration of study protocols and reports. |
| 30/09/2023 | Concept Paper on the development of a Guideline on the quality aspects of mRNA vaccines | The Concept Paper addresses the need to establish a guideline on the quality aspects of mRNA vaccines. The scope of the guideline focuses on the mRNA vaccines against infectious diseases (including self-amplifying mRNA). It is not intended to address specific requirements for mRNA vaccines to be used in clinical trials, but the scientific principles described may also be applicable during pharmaceutical development. |
| 31/12/2023 | Draft Reflection paper on the use of Artificial Intelligence (AI) in the medicinal product lifecycle | The document reflects on principles relevant to the application of AI and machine learning at any step of a medicine's lifecycle, from drug discovery to the post-authorisation setting. All interested parties are invited to comment on the consultation. |
EDQM
| Due date | Name of consultation | Scope of consultation |
| 30/09/2023 |
European Paediatric Formulary: Furosemide oral solution monograph |
The European Directorate for the Quality of Medicines & HealthCare (EDQM) released Issue 7 of Pharmeuropa PaedForm, in which the draft text for Furosemide 2 mg/mL Oral Solution is published for public consultation with a view to its later inclusion in the European Paediatric Formulary. EDQM welcomes all comments on the revised monograph from users and interested parties |
Others
No open consultation at the moment.
Last update: 9 August 2023
