Open consultations

Regulators and developers need high-quality tools to keep pace with scientific and technological advances and particularly to ensure the robust assessment of therapies and outcomes fitting patients’ needs. Research into regulatory science aims to address issues in development and evaluation as well as gaps that hinder regulatory advancement. EMA/HMA are launching the new European Platform for Regulatory Science Research. The platform aims to advance and accelerate regulatory science research, to increase the quality and impact of research and outcomes, thereby improving regulatory practices, standards, development and use of medicines and relevant devices or other technologies. Fostering the exchange and collaboration between researchers from the academic sector and regulators will help the system address gaps and research needs in regulatory science, improve the usefulness of outputs, and support the translation of solutions into the practice of regulators and developers. Please provide comments using this template. The completed comments form should be sent to [email protected].

Gaps exist in regulatory science that need to be addressed to improve medicine development and evaluation, to ultimately enable access to medicines that address patients’ needs. Research into regulatory science aims to address repeat issues in development and evaluation as well as gaps that hinder regulatory advancement. By highlighting regulatory science research needs, the goals are to stimulate research in these fields; to encourage researchers to consider in their area of work the regulatory and public health challenges and opportunities; to help researchers identify topics of common interest for interactions such as in the EMA/HMA European Platform for Regulatory science research  and for exploring with researchers pathways for translating results into solutions; and to offer the research needs for the awareness of funders so as to support their scoping of funding calls. Please provide comments using this template. The completed comments form should be sent to [email protected].

The European medicines regulatory network data strategy establishes a comprehensive framework to maximize the value of regulatory data while ensuring its quality, security, and ethical use. The strategy aligns with and supports the broader objectives outlined in the draft European medicines agencies network strategy to 2028, particularly in advancing data-driven decision-making and strengthening the network's digital capabilities. Comments should be provided until 31 December 2024 using this EUSurvey form.

Enabling tools are defined as novel technologies that have the potential to enable innovation and impact medicine development. As part of EMA’s horizon scanning and foresight activities, applicants to EMA procedures are asked to highlight the enabling tools applied in their development programs. This information is requested either when registering a Research Product Identifier (RPI) in IRIS (an EMA platform for submitting applications electronically). 
Following an analysis of the list of enabling technologies in 2023 and previous years, the EMA is updating the list of enabling technologies to better capture innovative features of proposed developments discussed. This draft list is open for public consultation until November 30. Comments should be provided using this EUSurvey form. For any technical issues, please contact EUSurvey Support.

EMA has opened a public consultation on the draft 2025-2027 Vaccines Working Party (VWP) Workplan which constitutes the roadmap of VWP activities on the basis of evolving identified priorities.

The workplan has been adopted by EMA’s human medicines committee (CHMP) and is now open for public consultation. All key stakeholders are therefore encouraged to provide their feedback through the EU survey no later than EOB 06 December 2024.

• Submission of comments on Vaccines Working Party (VWP) Work Plan 2025-2027

If you respond on behalf of a company that is affiliated with an EU (trade) industry organisations, you are encouraged to share your comments to the respective affiliated EU (Trade) Industry organisation.

This guideline replaces Note for Guidance on clinical investigation of medicinal products for the 10 treatment of peripheral arterial occlusive disease (CPMP/EWP/714/98 rev 1).

Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.

Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.

The European Medicines Agencies Network Strategy to 2028 will guide the network as it seizes opportunities and meets the challenges of the near future. This includes preparing for and responding to public health emergencies and threats such as antimicrobial resistance.

Comments should be provided using the EU survey form below:

Public consultation on European Medicines Agencies Network Strategy to 2028

This guideline replaces the Reflection paper on risk management requirements for elemental impurities in veterinary medicinal products, EMA/CVMP/QWP/153641/2018 and the Implementation of risk assessment requirements to control elemental impurities in veterinary medicinal products, EMA/CVMP/QWP/631010/2017-Rev.2.

Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.

This Q&A outlines the quality requirements for co-processed excipients (CoPE) used in solid oral dosage forms in both human and veterinary medicinal products. The use of CoPEs in pharmaceutical formulations is considered to have a higher degree of risk than using individual excipients due to several factors: for example complexity of composition, quality control, formulation development and stability issues. The Q&A aims to harmonise and quality clarify dossier requirements for CoPEs using a risk-based approach. It defines three risk categories for the CoPE and the risk factors the MAH/applicant should consider to identify the adequate risk category, and the related quality dossier requirements, which need to be provided by the MAH/applicants as part of new MAA or variations. 

Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support .

This guideline replaces Guideline on clinical investigation of medicinal products in the treatment and prevention of bipolar disorder (CPMP/EWP/567/98). 

Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.

Guideline concerning the application of Directive 2001/83/EC with a view to the granting of a marketing authorisation for a medicinal product. This guideline replaces the ‘Note for guidance on chemistry of new active substances’ (CPMP/QWP/130/96, Rev 1) and ‘Chemistry of active substances’ (3AQ5a). It has been revised to cover new and existing active substances in one guideline.

Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.

This guideline addresses specific aspects regarding the manufacturing process, characterisation, specifications and analytical control for synthetic oligonucleotides which are not covered in the Guideline on the Chemistry of Active Substances (EMA/454576/2016) or Chemistry of Active  Substances for Veterinary Medicinal Products (EMA/CVMP/QWP/707366/2017). It also contains requirements and considerations related to conjugation, to active substance in solution, to medicinal60
product development, to oligonucleotide generics development, to oligonucleotide personalised medicine approaches and to clinical trial applications (human products only).

Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.

 

This Guideline has been developed by the appropriate VICH Expert Working Group and is subject to consultation by the parties, in accordance with the VICH Process. At Step 7 of the Process the final draft will be recommended for adoption to the regulatory bodies of the European Union, Japan and 
USA.
Comments should be provided using this template. The completed comments form should be sent to [email protected].