Open consultations
The list below includes the European Medicines Agency's (EMA) open public consultations.
To reply to a consultation, please use the form for comments (which is also linked within each consultation document):
Please note that EMA may collect and further process some personal data of stakeholders and interested parties who submit contributions to the consultations. For more information, see:
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ICH guideline S11 on nonclinical safety testing in support of development of paediatric medicines - Step 2b - Draft guideline (PDF/1.76 MB)
Reference numberEMA/CHMP/ICH/616110/2018StatusDraft: consultation openFirst published27/09/2018Consultation dates24/09/2018 to 24/03/2019Email address for submissions
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Reflection paper on the use of aminopenicillins and their beta-lactamase inhibitor combinations in animals in the European Union: development of resistance and impact on human and animal health (PDF/984.37 KB)
Reference numberEMA/CVMP/AWP/842786/2015StatusDraft: consultation openFirst published21/09/2018Last updated21/09/2018Consultation dates21/09/2018 to 21/12/2018Email address for submissionsSummaryThe objective of this document is to review available information on the use of aminopenicillins and their beta-lactamase inhibitor combinations in veterinary medicines in the EU, their effect on the emergence of antimicrobial resistance (AMR) and the potential impact of resistance on human and animal health. The document provides information for the risk profiling, as recommended by the Antimicrobial Advice ad hoc Expert Group (AMEG) of the EMA.
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Reflection paper on resistance in ectoparasites (PDF/308.67 KB)
Reference numberEMA/CVMP/EWP/310225/2014StatusDraft: consultation openFirst published21/09/2018Last updated21/09/2018Consultation dates21/02/2018 to 31/08/2019Email address for submissionsSummaryThe Committee adopted a new draft reflection paper on ectoparasitic resistance (EMA/CVMP/EWP/310225/2014) for a 11-month period of public consultation. The reflection paper aims to give an overview of the currently known resistance situation in ectoparasites to active substances used in veterinary medicinal products with a special focus on Europe, and to provide a review of the current knowledge on resistance mechanisms.
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Draft qualification opinion on stride velocity 95th centile as a secondary endpoint in Duchenne Muscular Dystrophy measured by a valid and suitable wearable device (PDF/2.49 MB)
Reference numberEMA/CHMP/SAWP/527447/2018StatusDraft: consultation openFirst published21/09/2018Last updated21/09/2018Consultation dates21/09/2018 to 30/11/2018Email address for submissionsSummaryThis report provides a final agreed draft Context of Use for public consultation describing where Stride Velocity measured at the ankle 95th Centile is deemed by CHMP as an appropriate endpoint in studies to support regulatory decision making on medicines for the treatment of Duchenne Muscular Dystrophy (DMD), together with CHMP's scientific consideration of the submission leading to the draft opinion. The document also includes the questions posed by the applicant and also raised by CHMP to the Applicant, and all the data provided by the applicant in support of the Application.
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Concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate - Revision 1 (PDF/91.07 KB)
Reference numberEMA/PDCO/362462/2016StatusDraft: consultation openFirst published17/09/2018Last updated17/09/2018Consultation dates17/09/2018 to 16/12/2018Email address for submissionsSummaryThe Guideline on the investigation of medicinal products in the term and preterm neonates was prepared during the period from 2007 to 2009 and came into effect in 2010 (EMEA/536810/2008). Considerable experience of assessing PIP applications covering neonatal age subset has been gained since then and it has become apparent that some essential questions arise repeatedly during the assessment of Paediatric Investigation Plans (PIP) applications for products intended to be investigated and used in neonates. Furthermore, in recent years there has been increasing debate about neonatal research trends and standards, suggesting that the existing guidance even though approved only 5 years ago is not adequately addressing issues associated with the development and investigation of products in term and preterm neonates.
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Draft guideline on clinical investigation of medicinal products in the treatment of epileptic disorders - Revision 3 (PDF/727.6 KB)
Reference numberCHMP/EWP/566/98StatusDraft: consultation openFirst published17/08/2018Last updated17/08/2018Consultation dates17/08/2018 to 17/02/2019Email address for submissionsSummaryThe present document is a third revision of the existing guideline. It should be considered as general guidance on the development of medicinal products for the treatment of epileptic disorders and should be read in conjunction with other EMA and ICH guidelines, which may apply to these conditions and patient populations. The main changes to the existing guideline include incorporation of the new classification / definitions of seizure types and epilepsies, the acceptance of add-on studies in support of a monotherapy claim on a case-by-case basis, the inclusion of new sections on neonates and status epilepticus and other changes related to paediatric developments. This guideline provides assistance for the development and evaluation of medicinal products for the treatment of epilepsy in adults and children. The scope of this document is restricted to treatment of seizures in epileptic disorder although there are some remarks concerning non-seizure features of epilepsy syndromes.
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Draft guideline on specifications: test procedures and acceptance criteria for herbal substances, herbal preparations and herbal medicinal products/traditional herbal medicinal products - Revision 3 (PDF/303.3 KB)
Reference numberEMA/HMPC/162241/2005StatusDraft: consultation openFirst published15/08/2018Last updated15/08/2018Consultation dates15/08/2018 to 30/11/2018Email address for submissionsSummaryThis document addresses specifications, i.e. those tests, procedures, and acceptance criteria used to assure the quality of the herbal substances/preparations and herbal medicinal products at release and during the shelf-life.
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Draft guideline on quality of herbal medicinal products/traditional herbal medicinal products - Revision 3 (PDF/205.93 KB)
Reference numberEMA/HMPC/201116/2005StatusDraft: consultation openFirst published15/08/2018Last updated15/08/2018Consultation dates15/08/2018 to 30/11/2018Email address for submissionsSummaryThis document intends to cover the general quality aspects of herbal medicinal products for human and veterinary use, including traditional herbal medicinal products for human use. It describes the special problems of herbal medicinal products and the differences between medicinal products containing chemically defined active substances.
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Draft guideline on similar biological medicinal products containing recombinant granulocyte-colony stimulating factor (rG-CSF) - Revision 1 (PDF/150.49 KB)
Reference numberEMEA/CHMP/BMWP/31329/2005StatusDraft: consultation openFirst published15/08/2018Last updated15/08/2018Consultation dates15/08/2018 to 15/02/2019Email address for submissionsSummaryThe proposed guideline will replace annex to guideline on similar medicinal products containing biotechnology-derived proteins as active substance: Non-Clinical and Clinical Issues - Guidance on similar medicinal products containing recombinant granulocyte-colony stimulating factor, EMEA/CHMP/BMWP/31329/2005
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Draft guideline on the use of minimal residual disease as a clinical endpoint in multiple myeloma studies (PDF/126.46 KB)
Reference numberEMA/CHMP/459559/2018StatusDraft: consultation openFirst published06/08/2018Last updated06/08/2018Consultation dates06/08/2018 to 31/10/2018Email address for submissionsSummaryThe guideline aims to address the use of undetectable minimal residual disease (MRD) as an intermediate efficacy endpoint in controlled randomised clinical studies in patients with multiple myeloma (MM), adequately designed to demonstrate efficacy by relevant hard endpoints. MRD as an endpoint in this context would allow earlier approval of new drugs pending final confirmatory data.
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ICH M9 on biopharmaceutics classification system based biowaivers - Step 2b - First version (PDF/351.95 KB)
Reference numberEMA/CHMP/ICH/493213/2018StatusDraft: consultation openFirst published06/08/2018Last updated06/08/2018Consultation dates06/08/2018 to 06/02/2019Email address for submissionsSummaryThis new multidisciplinary guideline is proposed to address biopharmaceutics classification system (BCS)-based biowaivers. BCS-based biowaivers may be applicable to BCS Class I and III drugs, however BCS-based biowaivers for these two classes are not recognized worldwide. This means that pharmaceutical companies have to follow different approaches in the different regions. This guideline will provide recommendations to support the biopharmaceutics classification of medicinal products and will provide recommendations to support the waiver of bioequivalence studies. This will result in the harmonisation of current regional guidelines/guidance and support streamlined global drug development.
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Draft questions and answers on Data Monitoring Committees issues (PDF/105.13 KB)
Reference numberEMA/492010/2018StatusDraft: consultation openFirst published01/08/2018Last updated01/08/2018Consultation dates01/08/2018 to 31/07/2019Email address for submissionsSummaryThe aim of this question-and-answer document is to supplement the CHMP Data Monitoring Committee Guideline (Doc Ref. EMEA/CHMP/EWP/5872/03) by providing clarification on the role and necessity for a Data Monitoring Committee (DMC) in different phases of drug development and throughout the product lifecycle as well as with regard to the responsibilities for implementing DMC decisions.
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Draft guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells (PDF/322.12 KB)
Reference numberEMA/CAT/GTWP/671639/2008 Rev. 1StatusDraft: consultation openFirst published31/07/2018Last updated31/07/2018Consultation dates31/07/2018 to 31/07/2019Email address for submissionsSummaryThis guideline defines scientific principles and provides guidance for the development and evaluation of medicinal products containing genetically modified cells intended for use in humans and presented for marketing authorisation. Its focus is on the quality, nonclinical aspects and safety and efficacy requirements of genetically modified cells developed as medicinal products.
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Draft VICH GL58 Stability testing of new veterinary drug substances and medicinal products in climatic zones III and IV - First version (PDF/169.17 KB)
Reference numberEMA/CVMP/VICH/335918/2016StatusDraft: consultation openFirst published27/07/2018Last updated27/07/2018Consultation dates27/07/2018 to 31/12/2018Email address for submissionsSummaryThe guideline is an annex to the VICH parent stability guideline, stability testing of new veterinary drug substances and medicinal products (VICH GL3 (R)), and provides guidance regarding the stability data package for a new veterinary drug substance and medicinal product to be included in a registration application submitted within the regions in the climatic zones III and IV.
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Reflection paper on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics (SPC) harmonisation (PDF/2.4 MB)
Reference numberEMA/CVMP/849775/2017StatusDraft: consultation openFirst published27/07/2018Last updated27/07/2018Consultation dates27/07/2018 to 31/01/2019Email address for submissionsSummaryEstablished veterinary antibiotics are not always used at the authorised dose, and the dose may need to be reviewed in order to maintain their effectiveness whilst limiting the risks of antimicrobial resistance. Before a new dose is introduced, the company would typically have to conduct new studies to ensure it does not negatively affect the safety of the target animal, the consumer of animal produce, or the environment. This may reduce product availability, which could have a negative impact on antimicrobial resistance development. At the same time, the principles for ethical use of animals in medicine testing encourage alternatives to the use of animals in the testing of medicines. Therefore, the CVMP has launched a pilot project to develop and test desk-based methodologies to optimise the dose of established veterinary antibiotics. The resulting reflection paper is available for public consultation until 31 January 2019.
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Second draft guideline on the assessment of the risk to public health from antimicrobial resistance due to the use of an antimicrobial veterinary medicinal product in food-producing animals (PDF/565.7 KB)
Reference numberEMA/CVMP/AWP/706442/2013StatusDraft: consultation openFirst published27/07/2018Last updated27/07/2018Consultation dates27/07/2018 to 31/10/2018Email address for submissions
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Draft guideline on data requirements for veterinary medicinal products for the prevention of transmission of vector- borne diseases in dogs and cats (PDF/181.1 KB)
Reference numberEMA/CVMP/EWP/278031/2015StatusDraft: consultation openFirst published27/07/2018Last updated27/07/2018Consultation dates27/07/2018 to 31/08/2019Email address for submissions
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Concept paper on the need to develop a reflection paper on development of medicinal products to prevent and treat acute kidney injury (PDF/177.01 KB)
Reference numberEMA/CHMP/171100/2018 Corr.StatusDraft: consultation openFirst published09/07/2018Last updated30/07/2018Consultation dates30/07/2018 to 01/08/2019Email address for submissionsSummaryThe concept paper will include discussion of and recommendations for the requirements for evaluation and development of medicinal products for the prevention and/or treatment of acute kidney injury (AKI) and its long-term complications. Relevant topics for discussion include patient populations, endpoints, study methodology, and study duration.
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Draft guideline on the use of adjuvanted veterinary vaccines (PDF/181.05 KB)
Reference numberEMA/CVMP/IWP/315887/2017StatusDraft: consultation openFirst published05/07/2018Last updated05/07/2018Consultation dates05/07/2018 to 15/01/2019Email address for submissionsSummaryThe main aim of the guideline is to outline the information which should be included for the adjuvant in the marketing authorisation application (MAA) of an immunological veterinary medicinal product (IVMP). This guideline replaces the ‘Note for Guidance on the use of adjuvanted veterinary vaccines’. The guideline discusses the important aspects to consider for the adjuvant in an IVMP and provides guidance on the information on the adjuvant which should be included in Parts 2, 3 and 4 of the MAA. The details on the adjuvant which should be referred to in the SPC of the IVMP is also addressed in this guideline.
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Draft guideline on the summary of product characteristics (SPC) for veterinary medicinal products containing antimicrobial substances - Revision 1 (PDF/153.63 KB)
Reference numberEMA/CVMP/383441/2005-Rev.1StatusDraft: consultation openFirst published30/04/2018Last updated21/09/2018Consultation dates30/04/2018 to 31/08/2019Email address for submissionsSummaryThe guideline, which was developed to encourage optimal use and to minimise selection of antimicrobial resistance (AMR), was revised in order to improve consistency of the summary of product characteristics (SPCs) for antimicrobial products in the EU Member States.
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Draft guideline on clinical evaluation of vaccines - Revision 1 (PDF/448.17 KB)
Reference numberEMEA/CHMP/VWP/164653/05 Rev. 1StatusDraft: consultation openFirst published26/04/2018Last updated26/04/2018Consultation dates26/04/2018 to 30/10/2018Email address for submissionsSummaryThis guideline addresses the clinical evaluation of vaccines intended for the prevention of infectious diseases. It includes considerations for trials intended to document the safety, immunogenicity and efficacy of new candidate vaccines and to support changes in the prescribing information of licensed vaccines. It also considers the need for and use of vaccine effectiveness studies. The draft guideline includes specific considerations for clinical trials with vaccines in special populations, such as pregnant women or the elderly. It also adds considerations to priming and boosting strategies, including the option of heterologous prime-boost, which entails administration of one type of vaccine first followed by a different type of vaccine for the same pathogen later.
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Draft guideline on manufacture of the veterinary finished dosage form - Revision 1 (PDF/249.78 KB)
Reference numberEMA/CVMP/QWP/798401/2015StatusDraft: consultation openFirst published23/04/2018Last updated23/04/2018Consultation dates23/04/2018 to 22/10/2018Email address for submissions
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Draft addendum to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections to address paediatric-specific clinical data requirements - First version (PDF/305.9 KB)
Reference numberEMA/CHMP/187859/2017StatusDraft: consultation openFirst published06/04/2018Last updated06/04/2018Consultation dates06/04/2018 to 30/10/2018Email address for submissionsSummaryThis document proposes the development of an addendum to the Guideline on the evaluation of medicines indicated for treatment of bacterial infections CPMP/EWP/558/95 rev 2), to provide specific guidance on paediatric clinical development programmes to support the authorisation of antibacterial agents for treating infectious diseases in children.
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Draft ICH guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management - Step 2b - Annexes - First version (PDF/497.57 KB)
Reference numberEMA/CHMP/ICH/804273/2017StatusDraft: consultation openFirst published18/12/2017Last updated18/12/2017Consultation dates18/12/2017 to 18/12/2018Email address for submissionsSummaryAnnexes to the 'Draft ICH guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management - Step 2b - Annexes - First version'
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Draft ICH guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management - Step 2b - First version (PDF/575.95 KB)
Reference numberEMA/CHMP/ICH/804273/2017StatusDraft: consultation openFirst published18/12/2017Last updated18/12/2017Consultation dates18/12/2017 to 18/12/2018Email address for submissionsSummaryThis new guideline is proposed to provide guidance on a framework to facilitate the management of post-approval chemistry, manufacturing and controls (CMC) changes in a more predictable and efficient manner across the product lifecycle. This guideline aims to promote innovation and continual improvement, and strengthen quality assurance and reliable supply of product, including proactive planning of supply chain adjustments. The guideline strives to promote, for regulators (assessors and inspectors), an improved understanding of the Applicants’ pharmaceutical quality systems (PQSs) for management of post-approval CMC changes. This new guideline is intended to complement the existing ICH Q8 to Q11 guidelines.
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Quality review of documents (QRD) template ‘Particulars to appear on the immediate package – combined label and package leaflet’ for veterinary medicinal products authorised via the centralised, mutual recognition and de... (PDF/207.3 KB)
Reference numberEMA/195158/2017StatusDraft: consultation openFirst published03/04/2017Last updated03/04/2017Consultation dates03/04/2017 to 31/10/2018Email address for submissionsSummaryThis template is designed for applicants who plan to put all labelling and leaflet information on the immediate packaging instead of printing a package leaflet. This is in line with Article 61(1) of the Veterinary Directive. The aim is to harmonise existing initiatives at the national level (driven by the need for such a template) and to ensure that critical elements are prominently located on these types of packs. An 18-month pilot phase will enable applicants and competent authorities to gain experience in using the template within pre- or post-authorisation applications. The aim after the pilot is to incorporate the combined label-leaflet within the main set of QRD veterinary templates. Please send comments using the comments form to qrd@ema.europa.eu until 31 October 2018.
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