The guideline on veterinary good pharmacovigilance practices (VGVP) Module: Signal Management (EMA/522332/2021) was initially adopted in November 2021 and came into effect in January 2022. The current 2021 version of the document makes reference to future revisions, should these be warranted by the experience gained by all stakeholders involved in the signal management process. This concept paper addresses the need for a thorough revision of the guideline, applying the experience gained with the implementation of Regulation (EU) 2019/6 on the signal management process.

Comments should be providedusing this template. The completed comments form should be sent tovet-guidelines@ema.europa.eu

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

This concept paper aims to outline the rationale, objectives, and proposed changes for the targeted update of Annex 6, Manufacture of Medicinal Gases, of the Good Manufacturing Practice (GMP) guide, that is common to the Member States of the European Union (EU)/European Economic Area (EEA) as well as to the Participating Authorities of the Pharmaceutical Inspection Co-operation Scheme (PIC/S). The aim of the revision is to carry out a limited review and update of the guideline to reflect industry’s current practices, including the use of new technologies and computerized systems.

Those participating in the public consultation are asked to please submit comments via theEU Survey tool.

This concept paper aims to outline the rationale, objectives, and proposed changes for the targeted update of Annex 15, Qualification and validation, of the Good Manufacturing Practice (GMP) guide, that is common to the Member States of the European Union (EU)/European Economic Area (EEA) as well as to the Participating Authorities of the Pharmaceutical Inspection Co-operation Scheme (PIC/S). The aim of the revision is to extend the scope of the annex to active substances manufacturers and to consider the revision of ICH guideline Q9 (R1) on quality risk management.

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The purpose of the proposed guideline is to address key considerations for studies that utilise Bayesian statistics in clinical development.

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The proposed guideline will replace the Guideline on clinical evaluation of diagnostic agents (CPMP/EWP/1119/98/Rev. 1) and the Appendix 1 to the guideline on clinical evaluation of diagnostic agents (CPMP/EWP/1119/98 REV. 1) on imaging agents (EMEA/CHMP/EWP/321180/2008).

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Comments should be provided usingthis template. The completed comments form should be sent tovet-guidelines@ema.europa.eu 

This revision will replace the current version of the CVMP guideline on veterinary medicinal products controlling Varroa destructor parasitosis in bees (EMA/CVMP/EWP/459883/2008-Rev.1).
Comments should be provided usingthis template. The completed comments form should be sent tovet-guidelines@ema.europa.eu 

This guideline replaces the 'Guideline for demonstration of efficacy of ectoparasiticides' (7AE17a).

Comments should be provided usingthis template. The completed comments form should be sent tovet-guidelines@ema.europa.eu 

This guideline replaces the current version of the Guideline on the requirements for combined vaccines and associations of immunological veterinary medicinal products (IVMPs) (EMA/CVMP/IWP/594618/2010). The guideline was revised in order to adapt legal references to the current legislation and reflect the experience that was gained with the guideline since it is in force. In addition, new approaches in vaccine development and alternative approaches to assess the absence of immunological interference in the associated use of vaccines are considered in the revision. This information is also included in the guideline. 

Comments should be provided usingthis template. The completed comments form should be sent tovet-guidelines@ema.europa.eu 

Comments should be provided using thisEUSurvey form. For any technical issues, please contact theEUSurvey Support.

Comments should be provided using thistemplate. The completed comments form should be sent toich@ema.europa.eu 

This guideline replaces the ‘Guideline on Radiopharmaceuticals’ (EMEA/CHMP/QWP/306970/2007). Comments should be provided using thisEUSurvey form. For any technical issues, please contact theEUSurvey Support.

The proposed revised guideline will replace the 'Guideline on good pharmacogenomic practice' (EMA/CHMP/718998/2016). Comments should be provided using thisEUSurvey form. For any technical issues, please contact theEUSurvey Support.

The proposed guideline will replace the Guideline on clinical investigation of medicinal products in the treatment of Parkison’s disease (EMA/CHMP/330418/2012 rev. 2, 7 July 2012).

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This concept paper proposes the development of a guideline to provide advice on data requirements and methodology for assessing the risk to public health from antimicrobial resistance due to the use of an antimicrobial veterinary medicinal product (VMP) in non-food-producing animal species to address regulatory requirements laid in Regulation (EU) 2019/6. In view of the experience and knowledge with antimicrobials for pets, the intended guideline will be developed with a focus on companion animals, although all non-food-producing animals are in scope.

Comments should be provided using this template. The complete comments form should be sent to awpsecretariat@ema.europa.eu 

This guideline replaces the 'Guideline on the choice of the non-inferiority margin' (EMEA/CPMP/EWP/2158/99) and ‘Points to consider on switching between superiority and non-inferiority' (CPMP/EWP/482/99).

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Comments should be provided using thisEUSurvey form. For any technical issues, please contact theEUSurvey Support.

This guideline replaces the guideline on the clinical evaluation of medicinal products intended for the treatment of Hepatitis B (CHMP/EWP/6172/03). Comments should be provided using thisEUSurvey form. For any technical issues, please contact theEUSurvey Support.